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
17700 Orthopedic devices
11851–11875 of 17700
Cleared Dec 31, 2003
BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · Linvatec Corp.
HWC · Screw, Fixation, Bone · 23d
Cleared Dec 23, 2003
SUBTALAR PEG IMPLANT
K033046 · Nexa Orthopedics, Inc.
MJW · Prosthesis, Subtalar, Plug, Polymer · 85d
Cleared Dec 22, 2003
FIDJI SMALL CEMENT RESTRICTOR
K030767 · Spine Next SA
JDK · Prosthesis, Hip, Cement Restrictor · 286d
Cleared Dec 22, 2003
FIDJI LARGE CEMENT RESTRICTOR
K030871 · Spine Next SA
JDK · Prosthesis, Hip, Cement Restrictor · 278d
Cleared Dec 19, 2003
REVOLUTION SPINAL FIXATION SYSTEM
K032219 · Spinal Innovations, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 151d
Cleared Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288 · Orthovita, Inc.
MQV · Filler, Bone Void, Calcium Compound · 148d
Cleared Dec 19, 2003
GEM INSET PATELLAR COMPONENT
K032950 · Kinamed, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 88d
Cleared Dec 19, 2003
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · Biomet, Inc.
JDC · Prosthesis, Elbow, Constrained, Cemented · 70d
Cleared Dec 18, 2003
COMPRESS DISTAL FEMORAL REPLACEMENT
K031804 · Biomet, Inc.
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 190d
Cleared Dec 18, 2003
MODIFICATION TO SLIM GLIDING NAIL SYSTEM
K033763 · Plus Orthopedics
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 16d
Cleared Dec 17, 2003
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086 · Biomet, Inc.
LOD · Bone Cement · 342d
Cleared Dec 17, 2003
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM)
K032358 · Disc-O-Tech Medical Technologies, Ltd.
HRX · Arthroscope · 140d
Cleared Dec 17, 2003
MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
K033664 · Centerpulse Orthopedics, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 26d
Cleared Dec 15, 2003
AEQUALIS SHOULDER FRACTURE SYSTEM
K032679 · Tornier
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 108d
Cleared Dec 15, 2003
SUBTALAR ARTHRORISIS IMPLANT
K032902 · Nexa Orthopedics, Inc.
HWC · Screw, Fixation, Bone · 89d
Cleared Dec 15, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · Medtronic Sofamor Danek
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 61d
Cleared Dec 15, 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · Walter Lorenz Surgical, Inc.
HWC · Screw, Fixation, Bone · 17d
Cleared Dec 12, 2003
VERTELINK KOBRA SPINAL FIXATION SYSTEM
K032102 · Vertelink Corporation
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 157d
Cleared Dec 11, 2003
MBCP
K032268 · Biomatlante
MQV · Filler, Bone Void, Calcium Compound · 141d
Cleared Dec 10, 2003
SCORPIO LOW PROFILE TIBIAL TRAY
K032829 · Howmedica Osteonics Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 90d
Cleared Dec 10, 2003
STRYKER SPINE MAPS SYSTEM
K032855 · Howmedica Osteonics
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 89d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · Smith & Nephew, Inc.
HRS · Plate, Fixation, Bone · 19d
Cleared Dec 08, 2003
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
K032812 · Orthovita, Inc.
MQP · Spinal Vertebral Body Replacement Device · 90d
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · Biomet, Inc.
HRS · Plate, Fixation, Bone · 28d
Cleared Dec 04, 2003
DEPUY ASR RESURFACING FEMORAL HEADS
K032659 · DePuy Orthopaedics, Inc.
KXA · Prosthesis, Hip, Femoral, Resurfacing · 98d

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All categories 17700 HRS Plate, Fixation, Bone 1322 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 642 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 548 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 532 HSB Rod, Fixation, Intramedullary And Accessories 521 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 422