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	2
ALPHATEC SPINE
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	5
ALTUS PARTNERS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
BALMORAL MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	8
BLUE ORTHO
	SUBSTANTIALLY EQUIVALENT	4
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	9
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
COMERGE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	6
CORIN U.S.A. LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CUREXO, INC.
	SUBSTANTIALLY EQUIVALENT	4
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	4
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	3
ECENTIAL ROBOTICS
	SUBSTANTIALLY EQUIVALENT	5
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
EVOLUTION SPINE
	SUBSTANTIALLY EQUIVALENT	1
FIAGON GMBH
	SUBSTANTIALLY EQUIVALENT	1
FOUNDATION SURGICAL GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUSION ROBOTICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	7
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	2
INTEGRITY IMPLANTS, INC.
	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
LEM SURGICAL AG
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	6
MAZOR ROBOTICS , LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDIVIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	5
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC SOFAMOR DANEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDYSSEY CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT NAVIBOT INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	2
MONOGRAM ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
NOVARAD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NU VASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX US, LLC
	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	3
ORTHOSOFT INC. (D/B/A) ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	3
ORTOMA AB
	SUBSTANTIALLY EQUIVALENT	3
OSTEOCENTRIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PATHKEEPER SURGICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
POINT ROBOTICS MEDTECH, INC.
	SUBSTANTIALLY EQUIVALENT	5
PRACTICAL NAVIGATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	2
PROMETHEAN RESTORATIVE, LLC
	SUBSTANTIALLY EQUIVALENT	1
PROPRIO, INC.
	SUBSTANTIALLY EQUIVALENT	4
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	3
PYTHEAS NAVIGATION SAS
	SUBSTANTIALLY EQUIVALENT	1
REMEX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	6
REMEX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	4
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	5
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	2
STRYKER LEIBINGER GMBH & CO KG
	SUBSTANTIALLY EQUIVALENT	8
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SUITE 201, NATIONAL INNOVATION CENTRE
	SUBSTANTIALLY EQUIVALENT	1
SURGENTEC, LLC
	SUBSTANTIALLY EQUIVALENT	3
THINK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	12
TORNIER S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
TYBER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
ULRICH MEDICAL USA, INC.
	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
2021	1696	1700
2022	1568	1582
2023	1493	1497
2024	2354	2356
2025	3344	3351
2026	1660	1676

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Slipped	1422	1423
Detachment of Device or Device Component	1031	1031
Break	876	877
Incorrect, Inadequate or Imprecise Result or Readings	871	871
Use of Device Problem	788	788
Mechanical Problem	723	724
Human-Device Interface Problem	663	663
Imprecision	528	528
Application Program Problem: Parameter Calculation Error	486	486
Unintended Application Program Shut Down	430	430
Fracture	394	395
Connection Problem	383	383
Device-Device Incompatibility	358	358
Material Fragmentation	354	355
Malposition of Device	347	347
Unintended Movement	301	302
Adverse Event Without Identified Device or Use Problem	291	295
Mechanical Jam	245	248
Physical Resistance/Sticking	230	230
Material Twisted/Bent	203	203
Insufficient Device Problem Information	174	174
Positioning Problem	166	166
Improper or Incorrect Procedure or Method	151	151
Material Integrity Problem	147	148
Residue After Decontamination	140	140
Appropriate Device Problem Term/Code Not Available	135	135
Device Sensing Problem	128	128
Component Missing	123	123
Premature Separation	122	122
Leak/Splash	116	116
Material Deformation	114	114
Positioning Failure	100	100
Overheating of Device	98	120
Computer Software Problem	95	95
Mechanics Altered	93	93
Application Program Freezes or Fails to Launch	90	90
Failure to Calibrate	88	88
Unintended System Motion	84	84
Intermittent Continuity	77	77
Loose or Intermittent Connection	73	73
Device Reprocessing Problem	70	70
Solder Joint Fracture	65	65
Complete Loss of Power	60	60
Display or Visual Feedback Problem	55	55
Unstable	55	55
Material Separation	52	52
Noise, Audible	52	52
Incorrect Measurement	51	52
Difficult to Insert	49	49
Circuit Failure	49	49

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10329	10367
Spinal Column Injury	610	611
Unspecified Tissue Injury	255	256
Insufficient Information	233	235
Foreign Body In Patient	163	163
Bone Notching	144	144
Laceration(s)	77	77
Pain	72	74
Bone Fracture(s)	54	55
Nerve Damage	42	43
Unspecified Nervous System Problem	40	40
Device Embedded In Tissue or Plaque	39	39
Hemorrhage/Blood Loss/Bleeding	36	36
Cerebrospinal Fluid Leakage	34	34
Unspecified Infection	31	31
Post Operative Wound Infection	31	31
Muscle Weakness/Atrophy	29	29
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	27	27
Joint Laxity	24	24
Perforation	19	19
Numbness	18	18
Muscle/Tendon Damage	16	17
Ambulation or Postural Difficulties	16	16
Loss of Range of Motion	15	16
Dural Tear	15	15
Hematoma	13	13
Paralysis	13	13
Failure of Implant	12	13
Paresis	11	11
Bacterial Infection	9	9
Neuropathy	9	9
Spinal Cord Injury	8	8
Wound Dehiscence	8	8
Joint Dislocation	7	7
Erosion	6	6
Deformity/ Disfigurement	6	6
Paresthesia	6	6
Inadequate Osseointegration	6	6
Paraplegia	6	6
Seroma	6	6
Fever	5	5
Intracranial Hemorrhage	5	5
Cardiac Arrest	5	5
Urinary Retention	5	5
Discomfort	5	5
Rupture	5	5
Swelling/ Edema	5	5
Fibrosis	5	5
Tissue Breakdown	5	5
Damage to Ligament(s)	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Alphatec Spine, Inc.	II	Feb-11-2026
2	Alphatec Spine, Inc.	II	Nov-08-2022
3	Augmedics Ltd.	II	May-13-2025
4	Blue Belt Technologies, Inc	II	Jun-11-2024
5	Blue Belt Technologies, Inc	II	Jan-11-2024
6	Blue Belt Technologies, Inc	II	Oct-05-2023
7	Brainlab AG	II	Mar-28-2023
8	DePuy Orthopaedics, Inc.	II	May-02-2022
9	Exactech, Inc.	II	Jun-30-2023
10	Globus Medical, Inc.	II	Feb-07-2024
11	Globus Medical, Inc.	I	Jan-18-2024
12	Howmedica Osteonics Corp.	II	Mar-18-2026
13	Howmedica Osteonics Corp.	II	Oct-09-2024
14	Kico Knee Innovation Company	II	Jun-02-2026
15	Mako Surgical Corporation	II	Sep-09-2022
16	Mazor Robotics Ltd	II	Jan-16-2026
17	Mazor Robotics Ltd	II	Sep-16-2024
18	Mazor Robotics Ltd	II	Oct-12-2023
19	Medacta Usa Inc	II	Dec-03-2022
20	Medos International Sarl	II	Sep-02-2026
21	Medtronic Navigation, Inc.	II	Jan-27-2025
22	Medtronic Navigation, Inc.	II	Oct-10-2024
23	Medtronic Navigation, Inc.	II	Jan-10-2024
24	Medtronic Sofamor Danek USA, Inc	II	Aug-09-2023
25	NuVasive Inc	III	Feb-03-2023
26	ORTOMA AB	II	Sep-22-2025
27	Orthalign, Inc	II	Mar-24-2026
28	Orthosoft, Inc. dba Zimmer CAS	II	Mar-03-2022
29	SEASPINE ORTHOPEDICS CORPORATION	II	Dec-17-2025
30	Stryker Orthopaedics	II	May-28-2024
31	Think Surgical, Inc.	II	Jul-09-2026
32	Think Surgical, Inc.	II	Mar-20-2024
33	Tornier S.A.S.	II	Apr-08-2025
34	Tornier S.A.S.	II	Jan-10-2025