FDA Review Panel · OR

FDA 510(k) Orthopedic Devices

FDA 510(k) Orthopedic Devices - Regulatory Overview

FDA 510(k) orthopedic devices include implants, instruments and systems used in musculoskeletal surgery and rehabilitation. The FDA review panel code is OR.

Key categories:

  • Joint replacement implants - hip, knee, shoulder and ankle prostheses
  • Bone fixation systems - plates, screws, nails and external fixators
  • Spinal implants - cages, rods, pedicle screws and disc replacements
  • Surgical navigation - image-guided and robotic-assisted orthopedic surgery
  • Bone grafts and substitutes - synthetic and allograft bone repair materials

With 17,685 submissions, this is one of the largest 510(k) categories. Data sourced from FDA 510(k) public files. Updated monthly.

17985
Total
17965
Cleared
118d
Avg (2y)
1976
Since
17720 Orthopedic devices
13001–13025 of 17720
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · Howmedica Osteonics Corp.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 47d
Cleared Mar 20, 2001
PORTRAIT FEMORAL COMPONENT
K010560 · Biomet, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 22d
Cleared Mar 19, 2001
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K003910 · Zimmer, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 90d
Cleared Mar 19, 2001
BAUMER CEMENTED HIP PROSTHESIS
K003975 · Baumer, S.A
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 87d
Cleared Mar 19, 2001
BAUMER MULLER HIP PROSTHESIS
K003976 · Baumer, S.A
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 87d
Cleared Mar 19, 2001
SUPER REVO SUTURE ANCHOR
K003984 · Linvatec Corp.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 83d
Cleared Mar 19, 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535 · Endius, Inc.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 24d
Cleared Mar 13, 2001
MEMOGRAPH
K001354 · Biomedical Ent., Inc.
JDR · Staple, Fixation, Bone · 319d
Cleared Mar 13, 2001
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
K003911 · Terray Corp.
KWP · Appliance, Fixation, Spinal Interlaminal · 84d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · Exactech, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 28d
Cleared Mar 13, 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437 · Ebi, L.P.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 28d
Cleared Mar 09, 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
K003816 · Arthrex, Inc.
HWC · Screw, Fixation, Bone · 88d
Cleared Mar 09, 2001
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
K010367 · DePuy Orthopaedics, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 30d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274 · Smith & Nephew, Inc.
HWC · Screw, Fixation, Bone · 224d
Cleared Mar 07, 2001
ALLOFIT ACETABULAR SYSTEM
K003758 · Sulzer Orthopedics, Inc.
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 91d
Cleared Mar 06, 2001
SHAVER ABLATOR
K002088 · Linvatec Corp.
HRX · Arthroscope · 238d
Cleared Mar 01, 2001
TI-REPLICA HIP STEM
K003875 · DePuy Orthopaedics, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 76d
Cleared Mar 01, 2001
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X
K003893 · Oratec Interventions, Inc.
HRX · Arthroscope · 73d
Cleared Feb 28, 2001
ANATOMICAL PRESS-FIT HUMERAL STEM
K003801 · Sulzer Orthopedics, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 82d
Cleared Feb 23, 2001
FREEDLAND TENSION SYSTEM
K003648 · Etzem Technologies, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 88d
Cleared Feb 23, 2001
TRITON HIP SYSTEM
K003649 · Hayes Medical, Inc.
LWJ · Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented · 88d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249 · Medtronic Sofamor Danek, Inc.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 28d
Cleared Feb 22, 2001
MTP RESESURFACING JOINT-SMALL/9301-01
K003629 · Terray Corp.
KWD · Prosthesis, Toe, Hemi-, Phalangeal · 90d
Cleared Feb 20, 2001
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
K003659 · Bionx Implants, Inc.
HTY · Pin, Fixation, Smooth · 84d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700 · Synthes (Usa)
HWC · Screw, Fixation, Bone · 81d

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All categories 17720 HRS Plate, Fixation, Bone 1323 HWC Screw, Fixation, Bone 1054 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 920 NKB Thoracolumbosacral Pedicle Screw System 914 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 897 KWQ Appliance, Fixation, Spinal Intervertebral Body 664 HRX Arthroscope 646 MBI Fastener, Fixation, Nondegradable, Soft Tissue 604 LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented 562 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented 549 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 532 HSB Rod, Fixation, Intramedullary And Accessories 522 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 423