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
17714 Orthopedic devices
12701–12725 of 17714
Cleared Dec 11, 2001
MJS POSTERIOR STABILIZED KNEE SYSTEM
K012762 · Osteoimplant Technology, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 116d
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890 · United States Surgical, A Division of Tyco Healthc
HWC · Screw, Fixation, Bone · 18d
Cleared Dec 10, 2001
REUNITE FUSION SCREW
K011451 · Biomet, Inc.
HWC · Screw, Fixation, Bone · 213d
Cleared Dec 07, 2001
MOST OPTIONS SYSTEM
K013031 · Sulzer Orthopedics, Inc.
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 88d
Cleared Dec 07, 2001
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · Wrightmedicaltechnologyinc
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 88d
Cleared Dec 06, 2001
PLASMA SPRAYED SHOULDER
K003324 · Encore Orthopedics, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 408d
Cleared Dec 05, 2001
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · Exactech, Inc.
KWY · Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented · 70d
Cleared Dec 05, 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · Smith & Nephew, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 29d
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663 · Medtronic Sofamor Danek, Inc.
JDK · Prosthesis, Hip, Cement Restrictor · 29d
Cleared Dec 05, 2001
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
K013676 · Howmedica Osteonics Corp.
MEH · Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate · 28d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · Howmedica Osteonics Corp.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 28d
Cleared Dec 05, 2001
AUTOGENESIS AUTOMATOR, MODEL M1000
K013818 · Autogenesis, Inc.
JEC · Component, Traction, Invasive · 19d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · Biomet Manufacturing, Inc.
HWC · Screw, Fixation, Bone · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc.
HWC · Screw, Fixation, Bone · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa)
HWC · Screw, Fixation, Bone · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa)
HWC · Screw, Fixation, Bone · 84d
Cleared Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657 · Biomet Orthopedics, Inc.
HRS · Plate, Fixation, Bone · 27d
Cleared Dec 03, 2001
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K013772 · Howmedica Osteonics
LXT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite · 20d
Cleared Nov 29, 2001
RESECTION ABLATOR
K013117 · Linvatec Corp.
HRX · Arthroscope · 72d
Cleared Nov 27, 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · Ebi, L.P.
KWP · Appliance, Fixation, Spinal Interlaminal · 113d
Cleared Nov 27, 2001
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
K012916 · Depuy Acromed, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 89d
Cleared Nov 27, 2001
APEX MODULAR ALUMINA FEMORAL HEAD
K012918 · Apex Surgical, LLC
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 89d
Cleared Nov 26, 2001
C3 ANTERIOR CERVICAL PLATE SYSTEM
K012881 · Spine Vision, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 90d
Cleared Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546 · Bionx Implants, Inc.
HWC · Screw, Fixation, Bone · 28d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
K012817 · Triage Medical, Inc.
HWC · Screw, Fixation, Bone · 90d

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All categories 17714 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 644 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