• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device orthopedic 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 5
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
AUGMEDICS LTD
  SUBSTANTIALLY EQUIVALENT 1
AUGMEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 8
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 3
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 9
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CORELINK LLC
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 4
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CUREXO, INC.
  SUBSTANTIALLY EQUIVALENT 2
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
ECENTIAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 1
FUSION ROBOTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
HANGZHOU LANCET ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSIGHT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 1
INTELLIJOINT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 2
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 2
KICO KNEE INNOVATION COMPANY PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
MAZOR ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 5
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
MEDTRONIC SOFAMOR DANEK, USA INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT NAVIBOT INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  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, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
ORTHALIGN INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHALIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX 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 4
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 2
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 3
POINT ROBOTICS MEDTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PRACTICAL NAVIGATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
PREMIA SPINE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROPRIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMEX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
REMEX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 3
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL THEATER, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1233 1233
2019 1585 1585
2020 2744 2744
2021 1699 1699
2022 1570 1578
2023 458 458

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1107 1107
Material Integrity Problem 1067 1067
Mechanical Problem 772 772
Use of Device Problem 493 493
Fracture 441 441
Non Reproducible Results 435 435
Insufficient Information 421 421
Unintended Application Program Shut Down 417 417
Computer Software Problem 402 402
Application Program Problem: Parameter Calculation Error 338 338
Detachment of Device or Device Component 332 332
Imprecision 316 316
Connection Problem 315 315
Adverse Event Without Identified Device or Use Problem 236 236
Output Problem 218 218
Incorrect, Inadequate or Imprecise Result or Readings 215 215
Material Deformation 202 202
Physical Resistance/Sticking 181 181
Material Twisted/Bent 172 172
Device Slipped 170 170
Unintended Movement 153 153
Application Program Problem 150 150
Residue After Decontamination 137 137
Mechanical Jam 133 133
Defective Component 127 127
Device-Device Incompatibility 121 121
Solder Joint Fracture 110 110
Display or Visual Feedback Problem 107 107
Positioning Problem 97 97
Failure to Calibrate 93 93
Overheating of Device 90 90
Mechanics Altered 88 88
Positioning Failure 81 81
Malposition of Device 76 76
Intermittent Communication Failure 67 67
Appropriate Term/Code Not Available 64 64
Loose or Intermittent Connection 64 64
Failure to Recalibrate 62 62
Circuit Failure 58 58
Noise, Audible 57 57
Material Frayed 56 56
Application Program Freezes, Becomes Nonfunctional 52 52
Image Display Error/Artifact 51 51
Device Sensing Problem 49 49
Electrical /Electronic Property Problem 41 41
No Apparent Adverse Event 40 40
Difficult to Insert 39 39
Computer Operating System Problem 37 37
Improper or Incorrect Procedure or Method 37 37
Incorrect Measurement 34 34
Defective Device 33 33
Premature Separation 32 32
Inappropriate Tactile Prompt/Feedback 30 30
Calibration Problem 30 30
Failure to Power Up 30 30
Crack 30 30
Material Fragmentation 29 29
Device Operates Differently Than Expected 28 28
Electrical Power Problem 27 27
Difficult to Remove 27 27
Complete Loss of Power 27 27
Entrapment of Device 26 26
Deformation Due to Compressive Stress 26 26
Unstable 26 26
Contamination /Decontamination Problem 25 25
Contamination of Device Ingredient or Reagent 25 25
Intermittent Loss of Power 25 25
Communication or Transmission Problem 24 24
No Display/Image 24 24
Naturally Worn 23 23
Difficult or Delayed Positioning 22 22
Suction Problem 22 22
Device Dislodged or Dislocated 21 21
Retraction Problem 20 20
Material Split, Cut or Torn 20 20
No Visual Prompts/Feedback 19 19
Inadequacy of Device Shape and/or Size 18 18
Image Orientation Incorrect 17 17
Bent 16 16
Operating System Becomes Nonfunctional 16 16
Power Problem 16 16
Sharp Edges 15 15
Degraded 15 15
Fluid/Blood Leak 15 15
Electrical Shorting 15 15
Battery Problem 15 15
Separation Failure 14 14
Component Missing 13 13
Loss of Osseointegration 13 13
Contamination 13 13
Erratic or Intermittent Display 12 12
Unintended System Motion 12 12
Fitting Problem 12 12
Failure to Align 12 12
Off-Label Use 11 11
Separation Problem 11 11
Corroded 10 10
Device Displays Incorrect Message 10 10
Device Difficult to Setup or Prepare 9 9
Material Separation 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3853 3861
No Known Impact Or Consequence To Patient 2901 2901
No Patient Involvement 1147 1147
No Consequences Or Impact To Patient 720 720
Injury 317 317
Foreign Body In Patient 122 122
Unspecified Tissue Injury 116 116
Pain 109 109
Insufficient Information 95 95
Bone Fracture(s) 78 78
Unspecified Infection 48 48
Tissue Damage 48 48
No Information 43 43
No Code Available 42 42
Device Embedded In Tissue or Plaque 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Laceration(s) 22 22
Failure of Implant 21 21
Nerve Damage 20 20
Joint Laxity 20 20
Discomfort 19 19
Cerebrospinal Fluid Leakage 18 18
Inadequate Osseointegration 17 17
Unspecified Nervous System Problem 16 16
Muscle Weakness 15 15
Not Applicable 13 13
Hip Fracture 10 10
Deformity/ Disfigurement 10 10
Post Operative Wound Infection 9 9
Loss of Range of Motion 9 9
Spinal Column Injury 9 9
Hemorrhage/Bleeding 9 9
Fibrosis 8 8
Complaint, Ill-Defined 7 7
Iatrogenic Source 7 7
Ambulation Difficulties 7 7
Numbness 6 6
Joint Dislocation 5 5
Damage to Ligament(s) 5 5
Erosion 5 5
Missing Value Reason 5 5
Swelling/ Edema 4 4
Wound Dehiscence 4 4
Fall 4 4
Paralysis 4 4
Paresis 4 4
Seroma 4 4
Perforation 3 3
Neuropathy 3 3
Headache 3 3
Hematoma 3 3
Aspiration/Inhalation 3 3
Bacterial Infection 3 3
Muscle/Tendon Damage 3 3
Tissue Breakdown 3 3
Fluid Discharge 2 2
Osteopenia/ Osteoporosis 2 2
Test Result 2 2
Peripheral Nervous Injury 2 2
Physical Asymmetry 2 2
Fever 2 2
Scar Tissue 2 2
Swelling 2 2
Rupture 2 2
Urinary Retention 2 2
Dizziness 2 2
Spinal Cord Injury 2 2
Blood Loss 2 2
Lethargy 1 1
Skin Tears 1 1
Sleep Dysfunction 1 1
Paraplegia 1 1
Needle Stick/Puncture 1 1
Collapse 1 1
Non-union Bone Fracture 1 1
Hypoesthesia 1 1
Perforation of Vessels 1 1
Weakness 1 1
Discharge 1 1
Synovitis 1 1
Therapeutic Effects, Unexpected 1 1
Thrombosis 1 1
Thrombus 1 1
Shock 1 1
Chest Pain 1 1
Cyst(s) 1 1
Deposits 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Erythema 1 1
Abscess 1 1
Achalasia 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Neurological Deficit/Dysfunction 1 1
Infiltration into Tissue 1 1
Inflammation 1 1
Intracranial Hemorrhage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Nov-08-2022
2 Blue Ortho II Oct-23-2020
3 Blue Ortho II Feb-11-2020
4 Brainlab AG II Mar-28-2023
5 Brainlab AG II Aug-29-2020
6 Brainlab AG II Aug-13-2020
7 Brainlab AG II Oct-11-2018
8 DePuy Orthopaedics, Inc. II May-02-2022
9 Exactech, Inc. II Jan-18-2018
10 Intellijoint Surgical, Inc. II Mar-23-2020
11 Intellijoint Surgical, Inc. II Aug-08-2019
12 K2M, Inc II Oct-07-2019
13 Mako Surgical Corporation II Sep-09-2022
14 Mako Surgical Corporation II Nov-19-2020
15 Mako Surgical Corporation II Jul-31-2020
16 Mako Surgical Corporation II Jun-16-2019
17 Mako Surgical Corporation II Sep-15-2018
18 Mako Surgical Corporation II Aug-24-2018
19 Mako Surgical Corporation II Aug-14-2018
20 Mako Surgical Corporation II May-04-2018
21 Mazor Robotics Ltd II Dec-20-2019
22 Medacta Usa Inc II Dec-03-2022
23 Medtronic Navigation, Inc. II Jun-09-2020
24 Medtronic Navigation, Inc. II Apr-10-2020
25 Medtronic Navigation, Inc. II Dec-19-2019
26 NuVasive Inc III Feb-03-2023
27 OMNIlife science Inc. II Jun-04-2019
28 Orthosoft, Inc. dba Zimmer CAS II Mar-03-2022
29 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
30 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
31 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
32 Smith & Nephew, Inc. II Apr-01-2020
33 Think Surgical, Inc. II Aug-06-2018
34 Zimmer Biomet, Inc. II Feb-16-2018
-
-