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	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
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	1
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	2
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	2
PYTHEAS NAVIGATION SAS
	SUBSTANTIALLY EQUIVALENT	1
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	2
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	3
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	4
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
SURGENTEC, LLC
	SUBSTANTIALLY EQUIVALENT	2
THINK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	11
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	1186	1192

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Slipped	1336	1337
Detachment of Device or Device Component	952	952
Break	882	885
Incorrect, Inadequate or Imprecise Result or Readings	831	831
Use of Device Problem	773	773
Mechanical Problem	705	706
Human-Device Interface Problem	639	639
Imprecision	522	522
Application Program Problem: Parameter Calculation Error	482	482
Unintended Application Program Shut Down	428	428
Fracture	384	385
Connection Problem	379	379
Malposition of Device	335	335
Device-Device Incompatibility	330	330
Material Fragmentation	330	331
Unintended Movement	297	298
Adverse Event Without Identified Device or Use Problem	287	291
Mechanical Jam	227	230
Physical Resistance/Sticking	225	225
Material Twisted/Bent	197	197
Insufficient Information	169	169
Positioning Problem	164	164
Material Integrity Problem	145	146
Residue After Decontamination	140	140
Improper or Incorrect Procedure or Method	139	139
Appropriate Term/Code Not Available	129	129
Device Sensing Problem	122	122
Component Missing	121	121
Premature Separation	119	119
Material Deformation	113	113
Positioning Failure	99	99
Mechanics Altered	95	95
Computer Software Problem	93	93
Leak/Splash	93	93
Overheating of Device	90	102
Application Program Freezes, Becomes Nonfunctional	89	89
Failure to Calibrate	87	87
Unintended System Motion	79	79
Loose or Intermittent Connection	77	77
Intermittent Continuity	77	77
Solder Joint Fracture	65	65
Complete Loss of Power	58	58
Device Reprocessing Problem	55	55
Noise, Audible	54	54
Display or Visual Feedback Problem	54	54
Unstable	54	54
Incorrect Measurement	51	52
Material Separation	51	51
Circuit Failure	49	49
Retraction Problem	46	46

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9905	9933
Spinal Column Injury	592	593
Unspecified Tissue Injury	254	255
Insufficient Information	228	230
Foreign Body In Patient	161	161
Laceration(s)	77	77
Pain	70	72
Bone Fracture(s)	53	54
Nerve Damage	39	40
Unspecified Nervous System Problem	39	39
Device Embedded In Tissue or Plaque	38	38
Cerebrospinal Fluid Leakage	33	33
Hemorrhage/Bleeding	31	31
Unspecified Infection	31	31
Post Operative Wound Infection	30	30
Muscle Weakness	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Joint Laxity	24	24
Perforation	19	19
Numbness	18	18
Ambulation Difficulties	16	16
Loss of Range of Motion	15	16
Muscle/Tendon Damage	15	16
Nicks, cuts or tears of dura or other tissues by device	13	13
Failure of Implant	12	13
Hematoma	12	12
Paralysis	11	11
Paresis	10	10
Neuropathy	9	9
Bacterial Infection	9	9
Wound Dehiscence	8	8
Spinal Cord Injury	7	7
Inadequate Osseointegration	6	6
Erosion	6	6
Joint Dislocation	6	6
Seroma	6	6
Deformity/ Disfigurement	6	6
Paraplegia	6	6
Paresthesia	6	6
Discomfort	5	5
Urinary Retention	5	5
Damage to Ligament(s)	5	5
Tissue Breakdown	5	5
Intracranial Hemorrhage	5	5
Fibrosis	5	5
Cardiac Arrest	5	5
Thrombosis/Thrombus	4	4
Burning Sensation	4	4
Fever	4	4
Movement Disorder	4	4

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	Medtronic Navigation, Inc.	II	Jan-27-2025
21	Medtronic Navigation, Inc.	II	Oct-10-2024
22	Medtronic Navigation, Inc.	II	Jan-10-2024
23	Medtronic Sofamor Danek USA, Inc	II	Aug-09-2023
24	NuVasive Inc	III	Feb-03-2023
25	ORTOMA AB	II	Sep-22-2025
26	Orthalign, Inc	II	Mar-24-2026
27	Orthosoft, Inc. dba Zimmer CAS	II	Mar-03-2022
28	SEASPINE ORTHOPEDICS CORPORATION	II	Dec-17-2025
29	Stryker Orthopaedics	II	May-28-2024
30	Think Surgical, Inc.	II	Mar-20-2024
31	Tornier S.A.S.	II	Apr-08-2025
32	Tornier S.A.S.	II	Jan-10-2025