TPLC - Total Product Life Cycle

• Device: thoracolumbosacral pedicle screw system
• Definition: Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
• Product Code: NKB
• Regulation Number: 888.3070
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ACCEL SPINE
	SUBSTANTIALLY EQUIVALENT	3
AESCULAP IMPLANT SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	3
AESCULAP IMPLANT SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
AESCULAP IMPLANT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	3
ALLEZ SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
ALPHATEC SPINE, INC
	SUBSTANTIALLY EQUIVALENT	3
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	14
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	6
ALTUS SPINE
	SUBSTANTIALLY EQUIVALENT	1
AMEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
AMENDIA, INC.
	SUBSTANTIALLY EQUIVALENT	4
ARTFX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
ARTHRO-DIF
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
ATLAS SPINE INC.
	SUBSTANTIALLY EQUIVALENT	2
AUXEIN MEDICAL PRIVATE LIMITED/71164
	SUBSTANTIALLY EQUIVALENT	1
AXIS ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
B2B SPINE PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
BACK 2 BASICS DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	3
BAUI BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
BAXANO SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BENVENUE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIEDERMANN MOTECH GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	3
BIOMET SPINE
	SUBSTANTIALLY EQUIVALENT	3
BIOMET SPINE (AKA EBI, LLC)
	SUBSTANTIALLY EQUIVALENT	4
BIOMET SPINE (EBI LLC)
	SUBSTANTIALLY EQUIVALENT	1
BIOMET SPINE LLC,
	SUBSTANTIALLY EQUIVALENT	1
BK MEDITECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BK MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BK MEDITECH, CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BLACK BOX MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
BLACK BOX MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
BLACKSTONE
	SUBSTANTIALLY EQUIVALENT	1
BLACKSTONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BM KOREA
	SUBSTANTIALLY EQUIVALENT	1
CALVARY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	8
CARBOFIX ORTHOPEDICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CG BIO CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHIRAL SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE
	SUBSTANTIALLY EQUIVALENT	2
CHOICE SPINE LP
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP
	SUBSTANTIALLY EQUIVALENT	3
CLARIANCE
	SUBSTANTIALLY EQUIVALENT	1
CLARIANCE SAS
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
CLEARVIEW ORTHOPEDIC DEVELOPMENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
COLIGNE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK LLC
	SUBSTANTIALLY EQUIVALENT	4
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	2
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CUMTOM SPINE
	SUBSTANTIALLY EQUIVALENT	1
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SPINE, INC.
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	11
DEPUY SPINE,INC
	SUBSTANTIALLY EQUIVALENT	1
DIO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EBI, L.P.
	SUBSTANTIALLY EQUIVALENT	4
EBI, LLC
	SUBSTANTIALLY EQUIVALENT	1
EISERTECH, LLC
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
EXPANDING ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
FACETLINK DBA LINKSPINE
	SUBSTANTIALLY EQUIVALENT	1
FLOSPINE
	SUBSTANTIALLY EQUIVALENT	1
G SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	4
GBS COMMONWEALTH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	6
GETSET SURGICAL, SA
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SE - WITH LIMITATIONS	2
	SUBSTANTIALLY EQUIVALENT	10
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	6
GM DOS REIS INDUSTRIA E COMERICO LTDA
	SUBSTANTIALLY EQUIVALENT	1
GPC MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GRAFTON MEDICAL ALLIANCE
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
GS MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
HOGAN LOVELLS US LLP
	SUBSTANTIALLY EQUIVALENT	1
HUVEXEL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	4
IMPLANET S.A.
	SUBSTANTIALLY EQUIVALENT	2
IMPLANET, S.A.
	SUBSTANTIALLY EQUIVALENT	2
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
INGENIUM SPINE
	SUBSTANTIALLY EQUIVALENT	1
INNOSYS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	2
INNOVATIVE SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	7
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRITY IMPLANTS, INC
	SUBSTANTIALLY EQUIVALENT	1
INTELIVATION LLC
	SUBSTANTIALLY EQUIVALENT	1
INTELLIGENT IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	3
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
JMT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	3
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K&J CONSULTING CORP.
	SUBSTANTIALLY EQUIVALENT	1
K2M
	SUBSTANTIALLY EQUIVALENT	1
K2M INC.
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC
	SUBSTANTIALLY EQUIVALENT	5
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	8
K2M, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
K2M, LLC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC DIRECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
KALITEC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
L & K BIOMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	13
LANTERNA MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
LANX, INC.
	SUBSTANTIALLY EQUIVALENT	7
LANX, LLC
	SUBSTANTIALLY EQUIVALENT	2
LDR SPINE USA INC.
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	3
LIFE SPINE, INC
	SUBSTANTIALLY EQUIVALENT	6
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
LIFE SPINE, LLC.
	SUBSTANTIALLY EQUIVALENT	1
LINKSPINE INC
	SUBSTANTIALLY EQUIVALENT	1
MAHE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	6
MEDICREA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	6
MEDICREA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	8
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	3
MEDOS-INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC SOFAMOR DANCK USA, INC.
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK
	SE - WITH LIMITATIONS	4
	SUBSTANTIALLY EQUIVALENT	9
MEDTRONIC SOFAMOR DANEK USA
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC SOFAMOR DANEK USA, INC
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC SOFAMOR DANEK USA, INC.
	SE - WITH LIMITATIONS	7
	SUBSTANTIALLY EQUIVALENT	27
MEDTRONIC SOFAMOR DANEK, INC.
	SUBSTANTIALLY EQUIVALENT	3
	SE - WITH LIMITATIONS	5
MEDYNUS INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY USA, INC.
	SUBSTANTIALLY EQUIVALENT	7
MET ONE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	4
NANOVIS LLC
	SUBSTANTIALLY EQUIVALENT	1
NANOVIS SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NANOVIS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEO MEDICAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NEUROSTRUCTURES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEXT ORTHOSURGICAL
	SUBSTANTIALLY EQUIVALENT	3
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	3
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	3
NUVASIVE INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	7
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	9
NVISION BIOMEDICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORBBO SURGICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ORION BIOTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	2
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ORTHOCIRCLE SPINE
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX
	SUBSTANTIALLY EQUIVALENT	2
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	3
ORTHOFIX, INC.
	SUBSTANTIALLY EQUIVALENT	4
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	2
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
OSSO SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
OSTEOCENTRIC TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA
	SUBSTANTIALLY EQUIVALENT	1
PAONAN BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
PARADIGM SPINE, LLC
	SE - WITH LIMITATIONS	3
PHAMEDICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHYGEN, LLC
	SUBSTANTIALLY EQUIVALENT	6
PINNACLE SPINE GROUP
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	4
PIONEER SURGICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
PREMIA SPINE LTD.
	SUBSTANTIALLY EQUIVALENT	5
PRESIDIO SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
QUALGENIX
	SUBSTANTIALLY EQUIVALENT	1
R&D INNOVATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, L.L.C.
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
RIVARP MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ROYAL OAK MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
S. M. A. I. O
	SUBSTANTIALLY EQUIVALENT	1
S.M.A.I.O
	SUBSTANTIALLY EQUIVALENT	2
S.M.A.I.O.
	SUBSTANTIALLY EQUIVALENT	1
SAFE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	9
SAGICO VA USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	12
SEASPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SENECKA SPINE
	SUBSTANTIALLY EQUIVALENT	2
SEOHANCARE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGDONG KANGSHENG MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI SANYOU MEDICAL CO, LTD
	SUBSTANTIALLY EQUIVALENT	4
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SOLCO BIOMEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SOLCO BIOMEDICAL COPANY INDIA PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SPARTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL BALANCE INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINAL BALANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ELEMENTS, INC
	SUBSTANTIALLY EQUIVALENT	1
SPINAL ELEMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	5
SPINAL RESOURCES, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINE SMITH HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	5
SPINEART
	SUBSTANTIALLY EQUIVALENT	5
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	1
SPINECRAFT LLC
	SUBSTANTIALLY EQUIVALENT	4
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	2
SPINEOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	7
SPINEOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	4
SPINESELECT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, S.A.
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY
	SUBSTANTIALLY EQUIVALENT	2
SPINEWAY S.A.
	SUBSTANTIALLY EQUIVALENT	1
SPINEWAY SA
	SUBSTANTIALLY EQUIVALENT	1
SPINEWELDING AG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP
	SE - WITH LIMITATIONS	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	2
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SPINE
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	11
SURGALIGN SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
SURGTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNTEC SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA)
	SUBSTANTIALLY EQUIVALENT	4
SYNTHES SPINE
	SUBSTANTIALLY EQUIVALENT	7
SYNTHES USA PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
TAEYEON MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TDM CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
THE SKELETAL DESIGN PARTNERSHIP LTD.
	SUBSTANTIALLY EQUIVALENT	1
THEKEN SPINE LLC
	SUBSTANTIALLY EQUIVALENT	2
THEKEN SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
TI-TAMED (PTY) LTD
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
TORREY SPINE
	SUBSTANTIALLY EQUIVALENT	1
U&I CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ULRICH GMBH & CO. KG
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	2
VALORUS SPINE
	SUBSTANTIALLY EQUIVALENT	1
VY SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
WILTROM CORPORATION LIMITED
	SUBSTANTIALLY EQUIVALENT	2
X-SPINE SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
XENCO MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
Z-MEDICAL GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	2
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER BIOMET SPINE, INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ZIMMER SPINE
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER SPINE, INC
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	6
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2014	1668	1668
2015	1446	1446
2016	1585	1585
2017	1615	1615
2018	1684	1684
2019	1915	1915
2020	2076	2076
2021	1735	1737
2022	1340	1340
2023	920	920
2024	515	515

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3292	3292
Adverse Event Without Identified Device or Use Problem	2959	2959
Fracture	1568	1568
Migration	1139	1140
Material Deformation	1067	1067
Loose or Intermittent Connection	913	913
Migration or Expulsion of Device	749	749
Detachment of Device or Device Component	525	525
Device Slipped	495	495
Device Dislodged or Dislocated	473	474
Loosening of Implant Not Related to Bone-Ingrowth	457	457
Unintended Movement	346	346
Device Operates Differently Than Expected	334	334
Material Twisted/Bent	294	294
Torn Material	263	263
Device-Device Incompatibility	249	249
Mechanical Problem	238	238
Insufficient Information	237	237
Appropriate Term/Code Not Available	229	229
Material Separation	167	167
Material Fragmentation	166	166
Disassembly	158	158
Malposition of Device	151	151
Detachment Of Device Component	142	142
Material Integrity Problem	109	109
Failure to Align	104	104
Material Split, Cut or Torn	103	103
Difficult to Remove	92	92
Mechanical Jam	91	91
Use of Device Problem	79	79
Fitting Problem	73	73
No Apparent Adverse Event	69	69
Improper or Incorrect Procedure or Method	66	66
Patient Device Interaction Problem	58	58
Metal Shedding Debris	55	55
Biocompatibility	54	54
Crack	52	52
Compatibility Problem	50	50
Positioning Problem	46	46
Entrapment of Device	41	41
Bent	40	40
Difficult to Insert	38	38
Failure To Adhere Or Bond	36	36
Disconnection	36	36
Calibration Problem	36	36
Noise, Audible	35	35
Device Damaged by Another Device	33	33
Mechanics Altered	32	32
Separation Problem	30	30
Patient-Device Incompatibility	28	28
Unstable	26	26
Naturally Worn	26	26
Premature Separation	25	25
Failure to Osseointegrate	24	24
Device Inoperable	23	23
Separation Failure	22	22
Device Markings/Labelling Problem	22	22
Corroded	18	18
Inaccurate Information	18	18
Inadequacy of Device Shape and/or Size	13	13
Expulsion	12	12
Physical Resistance/Sticking	12	12
Difficult to Advance	11	11
Failure to Disconnect	11	11
Osseointegration Problem	11	11
Nonstandard Device	11	11
Off-Label Use	10	10
Component or Accessory Incompatibility	10	10
Device Handling Problem	9	9
Peeled/Delaminated	9	9
Difficult To Position	9	9
Misassembled	8	8
Unintended Collision	8	8
Product Quality Problem	8	8
Positioning Failure	8	8
Packaging Problem	8	8
Connection Problem	8	8
Activation, Positioning or Separation Problem	8	8
Device Issue	8	8
Material Protrusion/Extrusion	7	7
Scratched Material	6	6
Unintended System Motion	6	6
Sticking	6	6
Component Falling	5	5
Unstable Capture Threshold	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Installation-Related Problem	5	5
Contamination /Decontamination Problem	5	5
Device Operational Issue	5	5
Misassembled During Installation	5	5
Defective Device	4	4
Device Or Device Fragments Location Unknown	4	4
Dull, Blunt	4	4
Failure to Advance	4	4
Contamination	4	4
Material Frayed	4	4
Flaked	3	3
Leak/Splash	3	3
Material Disintegration	3	3
Component Incompatible	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	3220	3220
No Code Available	2700	2700
No Clinical Signs, Symptoms or Conditions	2200	2202
Pain	2180	2181
Failure of Implant	1703	1704
Injury	1233	1233
No Consequences Or Impact To Patient	945	945
Unspecified Infection	731	731
No Information	532	532
Insufficient Information	502	502
Non-union Bone Fracture	404	404
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	292	292
No Patient Involvement	283	283
Impaired Healing	271	271
Spinal Column Injury	259	259
Not Applicable	201	201
Device Embedded In Tissue or Plaque	200	200
Osteolysis	198	198
Bone Fracture(s)	188	188
Foreign Body In Patient	178	178
Nerve Damage	167	167
Post Operative Wound Infection	114	114
Hypersensitivity/Allergic reaction	106	106
Joint Laxity	83	83
Discomfort	81	81
Fall	76	76
Neurological Deficit/Dysfunction	73	73
Reaction	70	70
Numbness	68	68
Patient Problem/Medical Problem	63	63
Stenosis	62	62
Hematoma	62	62
Sedation	58	58
Unspecified Tissue Injury	58	58
Paralysis	56	56
Death	54	54
Spinal Cord Injury	53	53
Inadequate Osseointegration	50	50
Tissue Damage	42	42
Cerebrospinal Fluid Leakage	33	33
Unspecified Nervous System Problem	32	32
Neuropathy	31	31
Abscess	30	30
Pressure Sores	30	30
Itching Sensation	29	29
Limited Mobility Of The Implanted Joint	28	28
Swelling/ Edema	28	28
Ambulation Difficulties	26	26
Vertebral Fracture	25	25
Blood Loss	24	24
Weakness	24	24
Swelling	23	23
Hemorrhage/Bleeding	21	21
Irritation	20	20
Dysphagia/ Odynophagia	19	19
Intraoperative Pain	19	19
Physical Asymmetry	18	18
Inflammation	17	17
Paraplegia	17	17
Cardiac Arrest	16	16
Pulmonary Embolism	15	15
Rash	15	15
Deformity/ Disfigurement	14	14
Fever	14	14
Visual Disturbances	13	13
Purulent Discharge	12	12
Muscle Weakness	12	12
Intervertebral Disc Compression or Protrusion	11	11
Skin Tears	11	11
Implant Pain	10	10
Paresis	10	10
Foreign Body Reaction	10	10
Necrosis	10	10
Disability	10	10
Inadequate Pain Relief	10	10
Joint Disorder	9	9
Ulcer	9	9
Loss of Range of Motion	9	9
Perforation of Vessels	9	9
Thrombosis	9	9
Dizziness	9	9
Wound Dehiscence	9	9
Bacterial Infection	9	9
Decreased Sensitivity	9	9
Vascular System (Circulation), Impaired	9	9
Test Result	8	8
Thromboembolism	8	8
Paresthesia	8	8
Malunion of Bone	8	8
Tingling	8	8
Hypoesthesia	8	8
Collapse	7	7
Local Reaction	7	7
Fatigue	7	7
Unspecified Musculoskeletal problem	7	7
Sudden Cardiac Death	6	6
Tissue Breakdown	6	6
Dyspnea	6	6
Arthritis	6	6
Laceration(s)	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Aug-26-2022
2	Aesculap Implant Systems LLC	II	Jul-21-2022
3	Aesculap Implant Systems LLC	II	Sep-07-2012
4	Alphatec Spine, Inc.	II	Jun-06-2017
5	Alphatec Spine, Inc.	II	Nov-16-2016
6	Alphatec Spine, Inc.	II	Jul-22-2014
7	Alphatec Spine, Inc.	II	Aug-27-2013
8	Alphatec Spine, Inc.	II	May-28-2013
9	Amendia, Inc	II	Jan-10-2018
10	Atlas Spine, Inc.	II	Aug-27-2012
11	Back 2 Basics Direct LLC	II	Aug-21-2018
12	Biomet Spine, LLC	II	Jul-20-2015
13	Biomet Spine, LLC	II	Feb-24-2015
14	Biomet Spine, LLC	II	Feb-11-2015
15	CTL Medical Corporation	II	Mar-20-2019
16	Clariance Inc	III	Jul-18-2019
17	Custom Spine, Inc.	II	Jul-29-2013
18	DePuy Spine, Inc.	II	May-26-2015
19	DePuy Spine, Inc.	II	Jan-24-2013
20	Ebi, Llc	II	Jan-05-2015
21	Ebi, Llc	II	Oct-22-2010
22	Genesys Orthopedics Systems, LLC	II	Sep-22-2014
23	Howmedica Osteonics Corp.	II	Aug-05-2019
24	Icotec Ag	II	Dec-19-2022
25	Innovasis, Inc	II	Feb-20-2018
26	Innovasis, Inc	II	Jan-19-2016
27	Innovasis, Inc	II	Jul-16-2014
28	Integra LifeSciences Corp.	II	Aug-11-2014
29	Integra LifeSciences Corp.	II	Jul-01-2014
30	Integra LifeSciences Corp.	II	Feb-07-2014
31	Integrity Implants Inc.	II	Dec-05-2022
32	Integrity Implants Inc.	II	Dec-05-2022
33	Medicrea International	II	Mar-02-2020
34	Medicrea International	II	Dec-30-2019
35	Medtronic Sofamor Danek USA Inc	II	Aug-03-2018
36	Medtronic Sofamor Danek USA Inc	II	Jul-25-2011
37	NuVasive Inc	II	Nov-19-2012
38	OrthoPediatrics Corp	II	Jul-30-2020
39	OrthoPediatrics Corp	II	Jan-08-2016
40	Orthofix Inc	II	Mar-16-2011
41	Orthofix Inc	II	Mar-08-2011
42	Orthofix, Inc	II	Aug-18-2017
43	Orthofix, Inc	II	Jun-10-2015
44	Orthofix, Inc.	II	Sep-07-2011
45	PIONEER SURGICAL TECHNOLOGY, INC.	II	Sep-09-2014
46	SAFE ORTHOPAEDICS LLC	II	Aug-24-2022
47	SPINEART SA	II	Jun-28-2021
48	SeaSpine Inc	II	Jun-20-2014
49	Spinal Elements, Inc	III	May-11-2015
50	Spinal Elements, Inc	III	May-07-2013
51	Stryker Spine	II	Nov-12-2015
52	Stryker Spine	II	Jun-05-2012
53	Stryker Spine	II	Feb-24-2010
54	Stryker Spine	II	Jun-26-2009
55	Synthes (USA) Products LLC	I	Nov-26-2014
56	Synthes USA (HQ), Inc.	II	Sep-15-2011
57	Synthes USA HQ, Inc.	II	Nov-26-2013
58	Synthes USA HQ, Inc.	II	Oct-01-2012
59	U&I CORP.	II	Jul-20-2020
60	XTANT Medical Holdings, Inc	II	Jan-29-2024
61	Zimmer Biomet Spine Inc.	II	Jan-04-2024
62	Zimmer Biomet Spine Inc.	II	Feb-22-2019
63	Zimmer Biomet, Inc.	II	Dec-15-2020
64	Zimmer Biomet, Inc.	II	Jun-02-2020
65	Zimmer Inc.	II	Oct-18-2010
66	Zimmer Inc.	II	Dec-22-2009
67	Zimmer Spine, Inc.	II	Mar-18-2016
68	Zimmer, Inc.	II	Jul-10-2012
69	Zimmer, Inc.	II	Jul-03-2012