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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeOLO
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
7D SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
7D SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
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 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 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
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 5
MAZOR ROBOTICS , LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 6
MEDIVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 3
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
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
ONPOINT SURGICAL, INC.
  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 4
ORTHOSOFT INC. (D/B/A) ZIMMER CAS
  SUBSTANTIALLY EQUIVALENT 2
ORTOMA AB
  SUBSTANTIALLY EQUIVALENT 2
OSTEOCENTRIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PATHKEEPER SURGICAL , LTD.
  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
PROMETHEAN RESTORATIVE, LLC
  SUBSTANTIALLY EQUIVALENT 1
PROPRIO, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 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 2
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 10
TORNIER S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC
  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

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 1129 1130
Break 787 790
Detachment of Device or Device Component 726 726
Incorrect, Inadequate or Imprecise Result or Readings 725 725
Use of Device Problem 724 724
Mechanical Problem 640 641
Human-Device Interface Problem 594 594
Imprecision 514 514
Application Program Problem: Parameter Calculation Error 445 445
Unintended Application Program Shut Down 419 419
Fracture 359 360
Connection Problem 357 357
Material Fragmentation 281 282
Malposition of Device 276 276
Unintended Movement 264 265
Adverse Event Without Identified Device or Use Problem 264 268
Device-Device Incompatibility 232 232
Physical Resistance/Sticking 215 215
Mechanical Jam 207 210
Material Twisted/Bent 179 179
Insufficient Information 158 158
Positioning Problem 149 149
Material Integrity Problem 144 145
Residue After Decontamination 139 139
Improper or Incorrect Procedure or Method 117 117
Appropriate Term/Code Not Available 115 115
Device Sensing Problem 115 115
Component Missing 110 110
Premature Separation 103 103
Mechanics Altered 92 92
Application Program Freezes, Becomes Nonfunctional 86 86
Positioning Failure 86 86
Material Deformation 84 84
Failure to Calibrate 82 82
Overheating of Device 79 85
Intermittent Continuity 77 77
Computer Software Problem 72 72
Leak/Splash 72 72
Loose or Intermittent Connection 68 68
Unintended System Motion 65 65
Solder Joint Fracture 65 65
Noise, Audible 53 53
Display or Visual Feedback Problem 52 52
Complete Loss of Power 51 51
Incorrect Measurement 49 50
Circuit Failure 49 49
Unstable 46 46
Intermittent Communication Failure 45 45
Retraction Problem 44 44
Material Separation 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8875 8897
Spinal Column Injury 553 554
Unspecified Tissue Injury 245 246
Insufficient Information 206 208
Foreign Body In Patient 143 143
Laceration(s) 69 69
Pain 61 63
Bone Fracture(s) 49 50
Device Embedded In Tissue or Plaque 37 37
Unspecified Nervous System Problem 37 37
Nerve Damage 35 36
Unspecified Infection 30 30
Hemorrhage/Bleeding 30 30
Cerebrospinal Fluid Leakage 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Post Operative Wound Infection 27 27
Muscle Weakness 24 24
Joint Laxity 23 23
Numbness 18 18
Perforation 17 17
Ambulation Difficulties 14 14
Loss of Range of Motion 14 15
Muscle/Tendon Damage 13 14
Failure of Implant 12 13
Hematoma 10 10
Bacterial Infection 9 9
Paresis 9 9
Paralysis 9 9
Neuropathy 8 8
Wound Dehiscence 8 8
Nicks, cuts or tears of dura or other tissues by device 8 8
Spinal Cord Injury 6 6
Paraplegia 6 6
Deformity/ Disfigurement 6 6
Erosion 6 6
Paresthesia 6 6
Joint Dislocation 6 6
Inadequate Osseointegration 6 6
Damage to Ligament(s) 5 5
Fibrosis 5 5
Intracranial Hemorrhage 5 5
Tissue Breakdown 5 5
Seroma 5 5
Discomfort 5 5
Swelling/ Edema 4 4
Movement Disorder 4 4
Rupture 4 4
Fever 4 4
Burning Sensation 4 4
Urinary Retention 4 4

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 Brainlab AG II Mar-28-2023
7 DePuy Orthopaedics, Inc. II May-02-2022
8 Exactech, Inc. II Jun-30-2023
9 Globus Medical, Inc. II Feb-07-2024
10 Globus Medical, Inc. I Jan-18-2024
11 Howmedica Osteonics Corp. II Oct-09-2024
12 Mako Surgical Corporation II Sep-09-2022
13 Mazor Robotics Ltd II Jan-16-2026
14 Mazor Robotics Ltd II Sep-16-2024
15 Mazor Robotics Ltd II Oct-12-2023
16 Medacta Usa Inc II Dec-03-2022
17 Medtronic Navigation, Inc. II Jan-27-2025
18 Medtronic Navigation, Inc. II Oct-10-2024
19 Medtronic Navigation, Inc. II Jan-10-2024
20 Medtronic Sofamor Danek USA, Inc II Aug-09-2023
21 NuVasive Inc III Feb-03-2023
22 ORTOMA AB II Sep-22-2025
23 Orthosoft, Inc. dba Zimmer CAS II Mar-03-2022
24 SEASPINE ORTHOPEDICS CORPORATION II Dec-17-2025
25 Stryker Orthopaedics II May-28-2024
26 Think Surgical, Inc. II Mar-20-2024
27 Tornier S.A.S. II Apr-08-2025
28 Tornier S.A.S. II Jan-10-2025
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