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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 1
AUGMEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 8
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 5
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 10
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
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 2
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 3
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 2
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
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
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 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 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 1
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 SAS
  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 2744 2744
2021 1696 1696
2022 1568 1576
2023 1493 1493
2024 2354 2354
2025 1593 1594

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1055 1055
Device Slipped 924 924
Use of Device Problem 781 781
Mechanical Problem 781 781
Incorrect, Inadequate or Imprecise Result or Readings 582 582
Imprecision 517 517
Application Program Problem: Parameter Calculation Error 508 508
Human-Device Interface Problem 498 498
Detachment of Device or Device Component 473 473
Unintended Application Program Shut Down 467 467
Fracture 400 400
Connection Problem 387 387
Insufficient Information 281 281
Material Integrity Problem 274 274
Adverse Event Without Identified Device or Use Problem 266 266
Unintended Movement 253 253
Material Twisted/Bent 253 253
Mechanical Jam 229 229
Physical Resistance/Sticking 226 226
Device-Device Incompatibility 206 206
Malposition of Device 192 192
Material Fragmentation 186 186
Computer Software Problem 181 181
Residue After Decontamination 149 149
Positioning Problem 143 143
Application Program Problem 143 143
Failure to Calibrate 113 113
Display or Visual Feedback Problem 113 113
Mechanics Altered 109 109
Device Sensing Problem 109 109
Defective Component 103 103
Solder Joint Fracture 100 100
Overheating of Device 100 100
Positioning Failure 99 99
Loose or Intermittent Connection 96 96
Appropriate Term/Code Not Available 93 93
Premature Separation 90 90
Intermittent Continuity 89 89
Improper or Incorrect Procedure or Method 80 80
Application Program Freezes, Becomes Nonfunctional 74 74
Component Missing 72 72
Intermittent Communication Failure 68 68
Failure to Recalibrate 62 62
Material Deformation 59 59
Circuit Failure 59 59
Leak/Splash 59 59
Noise, Audible 59 59
Complete Loss of Power 54 54
Output Problem 49 49
Computer Operating System Problem 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7871 7880
No Known Impact Or Consequence To Patient 1040 1040
No Patient Involvement 587 587
Spinal Column Injury 512 512
No Consequences Or Impact To Patient 493 493
Injury 253 253
Unspecified Tissue Injury 241 241
Insufficient Information 189 189
Foreign Body In Patient 158 158
Pain 85 85
Laceration(s) 63 63
Bone Fracture(s) 49 49
Unspecified Infection 42 42
Device Embedded In Tissue or Plaque 40 40
Unspecified Nervous System Problem 33 33
Nerve Damage 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Failure of Implant 26 26
Joint Laxity 26 26
Cerebrospinal Fluid Leakage 25 25
No Information 25 25
No Code Available 23 23
Hemorrhage/Bleeding 23 23
Muscle Weakness 22 22
Post Operative Wound Infection 17 17
Perforation 16 16
Ambulation Difficulties 15 15
Inadequate Osseointegration 14 14
Numbness 13 13
Loss of Range of Motion 12 12
Deformity/ Disfigurement 11 11
Fibrosis 9 9
Wound Dehiscence 8 8
Muscle/Tendon Damage 8 8
Hematoma 8 8
Paresis 8 8
Paralysis 7 7
Discomfort 7 7
Joint Dislocation 7 7
Neuropathy 7 7
Hip Fracture 6 6
Missing Value Reason 5 5
Bacterial Infection 5 5
Erosion 5 5
Spinal Cord Injury 5 5
Seroma 5 5
Damage to Ligament(s) 5 5
Rupture 4 4
Fluid Discharge 4 4
Swelling/ Edema 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 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 Orthosoft, Inc. dba Zimmer CAS II Mar-03-2022
31 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
32 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
33 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
34 Smith & Nephew, Inc. II Apr-01-2020
35 Stryker Orthopaedics II May-28-2024
36 Think Surgical, Inc. II Mar-20-2024
37 Tornier S.A.S. II Apr-08-2025
38 Tornier S.A.S. II Jan-10-2025
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