TPLC - Total Product Life Cycle

• Device: orthopedic stereotaxic instrument
• Regulation Description: 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	3
ALPHATEC SPINE
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ALTUS PARTNERS LLC.
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	8
BLUE ORTHO
	SUBSTANTIALLY EQUIVALENT	5
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	11
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
COMERGE AG
	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	4
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE
	SUBSTANTIALLY EQUIVALENT	1
FIAGON GMBH
	SUBSTANTIALLY EQUIVALENT	1
FUSION ROBOTICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
GS MEDICAL CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
GYDER SURGICAL PTY 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	3
INSIGHT MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
LEM SURGICAL AG
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	7
MAZOR ROBOTICS LTD.
	SUBSTANTIALLY EQUIVALENT	4
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	3
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC NAVIGATION, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	4
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT NAVIBOT INTERNATIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS LLC
	SUBSTANTIALLY EQUIVALENT	1
MONOGRAM ORTHOPAEDICS, INC
	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
ORTHOFIX US LLC
	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	1
ORTHOSOFT INC. (D/B/A) ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORTOMA AB
	SUBSTANTIALLY EQUIVALENT	2
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
OSTEOCENTRIC TECHNOLOGIES, INC.
	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	2
PROPRIO, INC.
	SUBSTANTIALLY EQUIVALENT	3
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
REMEX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	5
REMEX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SI-BONE INC.
	SUBSTANTIALLY EQUIVALENT	1
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	3
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	2
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
TYBER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	1
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	2746	2765
2021	1696	1698
2022	1568	1578
2023	1493	1493
2024	2354	2354
2025	2786	2793

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1123	1125
Device Slipped	1058	1058
Mechanical Problem	872	872
Use of Device Problem	843	856
Incorrect, Inadequate or Imprecise Result or Readings	720	720
Detachment of Device or Device Component	655	655
Human-Device Interface Problem	582	582
Imprecision	532	532
Application Program Problem: Parameter Calculation Error	526	526
Unintended Application Program Shut Down	473	473
Fracture	430	430
Connection Problem	399	399
Adverse Event Without Identified Device or Use Problem	317	317
Insufficient Information	301	301
Unintended Movement	286	286
Material Integrity Problem	274	274
Material Fragmentation	272	278
Material Twisted/Bent	268	268
Malposition of Device	262	262
Mechanical Jam	256	256
Physical Resistance/Sticking	237	237
Device-Device Incompatibility	222	222
Computer Software Problem	195	195
Positioning Problem	153	153
Application Program Problem	153	153
Residue After Decontamination	151	151
Appropriate Term/Code Not Available	122	122
Failure to Calibrate	121	121
Device Sensing Problem	119	119
Display or Visual Feedback Problem	118	118
Positioning Failure	117	117
Mechanics Altered	111	111
Improper or Incorrect Procedure or Method	111	111
Overheating of Device	107	113
Component Missing	106	106
Defective Component	103	103
Loose or Intermittent Connection	102	102
Solder Joint Fracture	100	100
Premature Separation	98	98
Intermittent Continuity	89	89
Application Program Freezes, Becomes Nonfunctional	78	78
Material Deformation	69	69
Leak/Splash	68	68
Intermittent Communication Failure	68	68
Noise, Audible	64	64
Complete Loss of Power	63	63
Unintended System Motion	62	62
Failure to Recalibrate	62	62
Circuit Failure	59	59
Incorrect Measurement	52	53

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8865	8881
No Known Impact Or Consequence To Patient	1040	1040
No Patient Involvement	587	587
Spinal Column Injury	547	547
No Consequences Or Impact To Patient	493	493
Injury	253	253
Unspecified Tissue Injury	247	247
Insufficient Information	218	239
Foreign Body In Patient	179	179
Pain	94	94
Laceration(s)	67	67
Bone Fracture(s)	56	56
Unspecified Infection	45	45
Device Embedded In Tissue or Plaque	42	42
Nerve Damage	36	37
Unspecified Nervous System Problem	35	35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	31	31
Hemorrhage/Bleeding	28	28
Joint Laxity	28	28
Post Operative Wound Infection	28	28
Cerebrospinal Fluid Leakage	27	27
Failure of Implant	26	27
No Information	25	25
No Code Available	24	24
Muscle Weakness	24	24
Numbness	19	19
Perforation	17	17
Loss of Range of Motion	16	16
Ambulation Difficulties	15	15
Muscle/Tendon Damage	15	15
Deformity/ Disfigurement	14	14
Inadequate Osseointegration	14	14
Bacterial Infection	11	11
Wound Dehiscence	10	10
Paresis	9	9
Fibrosis	9	9
Neuropathy	8	8
Hematoma	8	8
Discomfort	8	8
Paralysis	8	8
Joint Dislocation	7	7
Spinal Cord Injury	6	6
Erosion	6	6
Nicks, cuts or tears of dura or other tissues by device	6	6
Hip Fracture	6	6
Seroma	6	6
Damage to Ligament(s)	5	5
Tissue Breakdown	5	5
Paraplegia	5	5
Missing Value Reason	5	5

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