TPLC - Total Product Life Cycle

• Device: orthopedic stereotaxic instrument
• Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
• Product Code: OLO
• Regulation Number: 882.4560
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
7D SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
7D SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
ALPHATEC SPINE
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
AUGMEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	10
BLUE ORTHO
	SUBSTANTIALLY EQUIVALENT	5
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	12
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
COMERGE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK LLC
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	6
CORIN LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CUREXO, INC.
	SUBSTANTIALLY EQUIVALENT	3
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	3
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	3
ECENTIAL ROBOTICS
	SUBSTANTIALLY EQUIVALENT	3
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FIAGON GMBH
	SUBSTANTIALLY EQUIVALENT	1
FUSION ROBOTICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
GLOBUS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU LANCET ROBOTICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	1
INNOSYS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIJOINT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
IZI MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	2
KALITEC DIRECT, LLC DOING BUSINESS AS KALITEC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
KICO KNEE INNOVATION COMPANY PTY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
KICO KNEE INNOVATION COMPANY PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	6
MAZOR ROBOTICS LTD.
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
MEDIVIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	2
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTECH S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC NAVIGATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC SOFAMOR DANEK, USA INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT NAVIBOT INTERNATIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NAVBIT PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	2
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NOVARAD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
ONPOINT SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOKEY ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT D/B/A ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	5
ORTHOSOFT INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	3
ORTHOSOFT INC. (D/B/A) ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORTOMA AB
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PATHKEEPER SURGICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
POINT ROBOTICS MEDTECH INC.
	SUBSTANTIALLY EQUIVALENT	3
POLARISAR INC.
	SUBSTANTIALLY EQUIVALENT	1
PRACTICAL NAVIGATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
PREMIA SPINE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROPRIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
REMEX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	4
REMEX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	2
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	6
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGALIGN SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL THEATER, INC.
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THINK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	11
TORNIER SAS
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	1
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	1585	1585
2020	2744	2744
2021	1696	1696
2022	1568	1576
2023	1493	1493
2024	2353	2354

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1141	1141
Material Integrity Problem	842	842
Device Slipped	835	836
Mechanical Problem	809	809
Use of Device Problem	712	712
Incorrect, Inadequate or Imprecise Result or Readings	500	500
Application Program Problem: Parameter Calculation Error	483	483
Fracture	471	471
Detachment of Device or Device Component	462	462
Unintended Application Program Shut Down	461	461
Connection Problem	382	382
Imprecision	354	354
Computer Software Problem	336	336
Insufficient Information	298	298
Adverse Event Without Identified Device or Use Problem	265	265
Unintended Movement	235	235
Non Reproducible Results	235	235
Physical Resistance/Sticking	224	224
Mechanical Jam	223	223
Material Twisted/Bent	218	218
Human-Device Interface Problem	198	198
Device-Device Incompatibility	193	194
Malposition of Device	169	169
Application Program Problem	154	154
Residue After Decontamination	148	148
Output Problem	147	147
Material Fragmentation	134	134
Positioning Problem	133	133
Defective Component	126	126
Display or Visual Feedback Problem	116	116
Solder Joint Fracture	110	110
Failure to Calibrate	107	107
Mechanics Altered	97	97
Overheating of Device	97	97
Positioning Failure	97	97
Device Sensing Problem	93	93
Premature Separation	92	92
Intermittent Continuity	88	88
Loose or Intermittent Connection	83	83
Appropriate Term/Code Not Available	82	82
Application Program Freezes, Becomes Nonfunctional	69	69
Intermittent Communication Failure	68	68
Material Deformation	67	67
Improper or Incorrect Procedure or Method	66	66
Noise, Audible	66	66
Failure to Recalibrate	62	62
Circuit Failure	59	59
Material Frayed	57	57
Incorrect Measurement	56	56
Complete Loss of Power	53	53

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6679	6688
No Known Impact Or Consequence To Patient	2068	2068
No Patient Involvement	901	901
No Consequences Or Impact To Patient	634	634
Injury	300	300
Spinal Column Injury	221	221
Unspecified Tissue Injury	213	213
Insufficient Information	169	169
Foreign Body In Patient	158	158
Pain	111	111
Bone Fracture(s)	75	75
Laceration(s)	56	56
Unspecified Infection	55	55
Device Embedded In Tissue or Plaque	42	42
No Code Available	40	40
Tissue Damage	36	36
Nerve Damage	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Unspecified Nervous System Problem	28	28
No Information	28	28
Failure of Implant	27	27
Joint Laxity	26	26
Cerebrospinal Fluid Leakage	22	22
Muscle Weakness	22	22
Hemorrhage/Bleeding	20	20
Inadequate Osseointegration	17	17
Discomfort	16	16
Ambulation Difficulties	14	14
Loss of Range of Motion	14	14
Post Operative Wound Infection	14	14
Numbness	12	12
Perforation	12	12
Deformity/ Disfigurement	11	11
Hip Fracture	10	10
Fibrosis	9	9
Paralysis	7	7
Paresis	7	7
Muscle/Tendon Damage	7	7
Wound Dehiscence	7	7
Spinal Cord Injury	7	7
Neuropathy	7	7
Damage to Ligament(s)	7	7
Hematoma	6	6
Joint Dislocation	6	6
Complaint, Ill-Defined	6	6
Missing Value Reason	5	5
Fall	5	5
Iatrogenic Source	5	5
Erosion	5	5
Rupture	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Alphatec Spine, Inc.	II	Nov-08-2022
2	Blue Belt Technologies, Inc	II	Jun-11-2024
3	Blue Belt Technologies, Inc	II	Jan-11-2024
4	Blue Belt Technologies, Inc	II	Oct-05-2023
5	Blue Ortho	II	Oct-23-2020
6	Blue Ortho	II	Feb-11-2020
7	Brainlab AG	II	Mar-28-2023
8	Brainlab AG	II	Aug-29-2020
9	Brainlab AG	II	Aug-13-2020
10	DePuy Orthopaedics, Inc.	II	May-02-2022
11	Exactech, Inc.	II	Jun-30-2023
12	Globus Medical, Inc.	II	Feb-07-2024
13	Globus Medical, Inc.	I	Jan-18-2024
14	Howmedica Osteonics Corp.	II	Oct-09-2024
15	Intellijoint Surgical, Inc.	II	Mar-23-2020
16	Intellijoint Surgical, Inc.	II	Aug-08-2019
17	K2M, Inc	II	Oct-07-2019
18	Mako Surgical Corporation	II	Sep-09-2022
19	Mako Surgical Corporation	II	Nov-19-2020
20	Mako Surgical Corporation	II	Jul-31-2020
21	Mako Surgical Corporation	II	Jun-16-2019
22	Mazor Robotics Ltd	II	Sep-16-2024
23	Mazor Robotics Ltd	II	Oct-12-2023
24	Mazor Robotics Ltd	II	Dec-20-2019
25	Medacta Usa Inc	II	Dec-03-2022
26	Medtronic Navigation, Inc.	II	Oct-10-2024
27	Medtronic Navigation, Inc.	II	Jan-10-2024
28	Medtronic Navigation, Inc.	II	Jun-09-2020
29	Medtronic Navigation, Inc.	II	Apr-10-2020
30	Medtronic Navigation, Inc.	II	Dec-19-2019
31	Medtronic Sofamor Danek USA, Inc	II	Aug-09-2023
32	NuVasive Inc	III	Feb-03-2023
33	OMNIlife science Inc.	II	Jun-04-2019
34	Orthosoft, Inc. dba Zimmer CAS	II	Mar-03-2022
35	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Nov-02-2020
36	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-31-2020
37	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-27-2020
38	Smith & Nephew, Inc.	II	Apr-01-2020
39	Stryker Orthopaedics	II	May-28-2024
40	Think Surgical, Inc.	II	Mar-20-2024
41	Tornier S.A.S.	II	Jan-10-2025