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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
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AUGMEDICS LTD
  SUBSTANTIALLY EQUIVALENT 1
AUGMEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 9
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 1
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
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 6
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 1
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
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 1
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 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMEX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
REMEX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 2
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  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 9
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 2353 2354
2025 935 935

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1009 1009
Device Slipped 861 862
Use of Device Problem 748 748
Mechanical Problem 713 713
Incorrect, Inadequate or Imprecise Result or Readings 516 516
Imprecision 506 506
Application Program Problem: Parameter Calculation Error 486 486
Unintended Application Program Shut Down 465 465
Human-Device Interface Problem 460 460
Fracture 389 389
Connection Problem 377 377
Detachment of Device or Device Component 354 354
Material Integrity Problem 274 274
Insufficient Information 260 260
Adverse Event Without Identified Device or Use Problem 252 252
Unintended Movement 242 242
Material Twisted/Bent 225 225
Physical Resistance/Sticking 223 223
Mechanical Jam 216 216
Device-Device Incompatibility 196 197
Computer Software Problem 176 176
Malposition of Device 172 172
Material Fragmentation 160 160
Residue After Decontamination 148 148
Application Program Problem 141 141
Positioning Problem 132 132
Display or Visual Feedback Problem 112 112
Mechanics Altered 109 109
Failure to Calibrate 108 108
Defective Component 103 103
Device Sensing Problem 102 102
Solder Joint Fracture 100 100
Overheating of Device 97 97
Appropriate Term/Code Not Available 89 89
Intermittent Continuity 89 89
Positioning Failure 88 88
Loose or Intermittent Connection 87 87
Premature Separation 83 83
Application Program Freezes, Becomes Nonfunctional 71 71
Improper or Incorrect Procedure or Method 68 68
Intermittent Communication Failure 68 68
Failure to Recalibrate 62 62
Circuit Failure 59 59
Noise, Audible 58 58
Leak/Splash 56 56
Material Deformation 54 54
Component Missing 51 51
Complete Loss of Power 49 49
Output Problem 48 48
Difficult to Insert 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7304 7313
No Known Impact Or Consequence To Patient 1040 1040
No Patient Involvement 587 587
No Consequences Or Impact To Patient 493 493
Spinal Column Injury 476 476
Injury 253 253
Unspecified Tissue Injury 222 222
Insufficient Information 177 177
Foreign Body In Patient 149 149
Pain 84 84
Laceration(s) 61 61
Bone Fracture(s) 48 48
Unspecified Infection 42 42
Device Embedded In Tissue or Plaque 37 37
Nerve Damage 31 31
Unspecified Nervous System Problem 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Failure of Implant 26 26
No Information 25 25
Joint Laxity 25 25
Cerebrospinal Fluid Leakage 24 24
No Code Available 23 23
Muscle Weakness 22 22
Hemorrhage/Bleeding 19 19
Inadequate Osseointegration 14 14
Ambulation Difficulties 14 14
Post Operative Wound Infection 14 14
Perforation 13 13
Numbness 13 13
Loss of Range of Motion 12 12
Deformity/ Disfigurement 11 11
Fibrosis 9 9
Paresis 8 8
Discomfort 7 7
Muscle/Tendon Damage 7 7
Wound Dehiscence 7 7
Hematoma 7 7
Neuropathy 7 7
Paralysis 7 7
Joint Dislocation 6 6
Hip Fracture 6 6
Missing Value Reason 5 5
Bacterial Infection 5 5
Erosion 5 5
Spinal Cord Injury 5 5
Rupture 4 4
Fluid Discharge 4 4
Swelling/ Edema 4 4
Damage to Ligament(s) 4 4
Fall 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Nov-08-2022
2 Blue Belt Technologies, Inc II Jun-11-2024
3 Blue Belt Technologies, Inc II Jan-11-2024
4 Blue Belt Technologies, Inc II Oct-05-2023
5 Blue Ortho II Oct-23-2020
6 Blue Ortho II Feb-11-2020
7 Brainlab AG II Mar-28-2023
8 Brainlab AG II Aug-29-2020
9 Brainlab AG II Aug-13-2020
10 DePuy Orthopaedics, Inc. II May-02-2022
11 Exactech, Inc. II Jun-30-2023
12 Globus Medical, Inc. II Feb-07-2024
13 Globus Medical, Inc. I Jan-18-2024
14 Howmedica Osteonics Corp. II Oct-09-2024
15 Intellijoint Surgical, Inc. II Mar-23-2020
16 Mako Surgical Corporation II Sep-09-2022
17 Mako Surgical Corporation II Nov-19-2020
18 Mako Surgical Corporation II Jul-31-2020
19 Mazor Robotics Ltd II Sep-16-2024
20 Mazor Robotics Ltd II Oct-12-2023
21 Medacta Usa Inc II Dec-03-2022
22 Medtronic Navigation, Inc. II Jan-27-2025
23 Medtronic Navigation, Inc. II Oct-10-2024
24 Medtronic Navigation, Inc. II Jan-10-2024
25 Medtronic Navigation, Inc. II Jun-09-2020
26 Medtronic Navigation, Inc. II Apr-10-2020
27 Medtronic Sofamor Danek USA, Inc II Aug-09-2023
28 NuVasive Inc III Feb-03-2023
29 Orthosoft, Inc. dba Zimmer CAS II Mar-03-2022
30 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
31 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
32 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
33 Smith & Nephew, Inc. II Apr-01-2020
34 Stryker Orthopaedics II May-28-2024
35 Think Surgical, Inc. II Mar-20-2024
36 Tornier S.A.S. II Jan-10-2025
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