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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 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 2
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 9
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 5
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 11
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS, LTD.
  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
CORIN, LTD.
  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 8
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
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 7
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 2
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
NAVBIT PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NAVISWISS AG
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVARAD CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
ONPOINT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHALIGN, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 4
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 3
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 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 S.A.S.
  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 1700
2022 1568 1582
2023 1493 1497
2024 2354 2356
2025 3003 3010

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1145 1148
Device Slipped 1088 1089
Mechanical Problem 889 890
Use of Device Problem 853 866
Incorrect, Inadequate or Imprecise Result or Readings 745 745
Detachment of Device or Device Component 695 695
Human-Device Interface Problem 589 589
Imprecision 534 534
Application Program Problem: Parameter Calculation Error 533 533
Unintended Application Program Shut Down 474 474
Fracture 430 431
Connection Problem 401 401
Adverse Event Without Identified Device or Use Problem 323 327
Insufficient Information 306 306
Unintended Movement 290 291
Material Fragmentation 282 289
Material Twisted/Bent 277 277
Material Integrity Problem 274 275
Malposition of Device 272 272
Mechanical Jam 260 263
Physical Resistance/Sticking 242 242
Device-Device Incompatibility 233 233
Computer Software Problem 195 195
Positioning Problem 155 155
Application Program Problem 153 153
Residue After Decontamination 152 152
Device Sensing Problem 122 122
Failure to Calibrate 122 122
Appropriate Term/Code Not Available 122 122
Positioning Failure 120 120
Display or Visual Feedback Problem 118 118
Improper or Incorrect Procedure or Method 118 118
Mechanics Altered 111 111
Component Missing 110 110
Overheating of Device 108 114
Defective Component 103 103
Loose or Intermittent Connection 102 102
Premature Separation 101 101
Solder Joint Fracture 100 100
Intermittent Continuity 89 89
Application Program Freezes, Becomes Nonfunctional 78 78
Material Deformation 73 73
Leak/Splash 71 71
Intermittent Communication Failure 68 68
Unintended System Motion 64 64
Noise, Audible 64 64
Complete Loss of Power 63 63
Failure to Recalibrate 62 62
Circuit Failure 59 59
Output Problem 53 53

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9063 9085
No Known Impact Or Consequence To Patient 1040 1040
No Patient Involvement 587 587
Spinal Column Injury 551 552
No Consequences Or Impact To Patient 493 493
Injury 253 253
Unspecified Tissue Injury 248 249
Insufficient Information 223 244
Foreign Body In Patient 182 182
Pain 95 97
Laceration(s) 67 67
Bone Fracture(s) 56 57
Unspecified Infection 45 45
Device Embedded In Tissue or Plaque 43 43
Nerve Damage 37 38
Unspecified Nervous System Problem 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Hemorrhage/Bleeding 29 29
Post Operative Wound Infection 29 29
Cerebrospinal Fluid Leakage 28 28
Joint Laxity 28 28
Failure of Implant 26 27
No Information 25 25
Muscle Weakness 24 24
No Code Available 24 24
Numbness 19 19
Perforation 17 17
Loss of Range of Motion 16 17
Ambulation Difficulties 15 15
Inadequate Osseointegration 15 15
Muscle/Tendon Damage 15 16
Deformity/ Disfigurement 14 14
Bacterial Infection 11 11
Wound Dehiscence 10 10
Hematoma 9 9
Fibrosis 9 9
Paresis 9 9
Discomfort 8 8
Neuropathy 8 8
Paralysis 8 8
Joint Dislocation 7 7
Spinal Cord Injury 6 6
Nicks, cuts or tears of dura or other tissues by device 6 6
Erosion 6 6
Hip Fracture 6 6
Seroma 6 6
Damage to Ligament(s) 5 5
Tissue Breakdown 5 5
Paraplegia 5 5
Intracranial Hemorrhage 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
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