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.

17816
Total
17799
Cleared
117d
Avg (2y)
1976
Since
7906 Orthopedic devices
6126–6150 of 7906
Cleared Dec 19, 2001
ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER
K013989 · Smith & Nephew, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 15d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · Howmedica Osteonics Corp.
KWP · Appliance, Fixation, Spinal Interlaminal · 30d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 82d
Cleared Dec 17, 2001
ACE BIO WIN TIBIAL NAILING SYSTEM
K013430 · DePuy Orthopaedics, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 62d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · DePuy Orthopaedics, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 69d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · Smith & Nephew, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 140d
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
GUARDIAN LIMB SALVAGE SYSTEM
K013035 · Wrightmedicaltechnologyinc
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 88d
Cleared Dec 05, 2001
MODIFICATION TO XIA SPINAL SYSTEM
K013688 · Howmedica Osteonics Corp.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 28d
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 REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · Smith & Nephew, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 29d
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 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · Synthes (Usa)
HWC · Screw, Fixation, Bone · 84d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · Synthes (Usa)
HWC · Screw, Fixation, Bone · 90d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572 · Biomet, Inc.
HWC · Screw, Fixation, Bone · 116d
Cleared Nov 16, 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · DePuy Orthopaedics, Inc.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 25d
Cleared Nov 16, 2001
LONG LENGTH DYAX NAIL
K013468 · Howmedica Osteonics Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 29d
Cleared Nov 16, 2001
INTEX SCREW
K012798 · Biomet, Inc.
HWC · Screw, Fixation, Bone · 87d
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · Howmedica Osteonics Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 88d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 179d
Cleared Nov 14, 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · Howmedica Osteonics Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 22d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · DePuy Orthopaedics, Inc.
MQV · Filler, Bone Void, Calcium Compound · 221d
Cleared Nov 07, 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · DePuy Orthopaedics, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 29d
Cleared Nov 02, 2001
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · Wrightmedicaltechnologyinc
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 84d

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All categories 7906 HRS Plate, Fixation, Bone 695 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 516 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 413 HWC Screw, Fixation, Bone 400 NKB Thoracolumbosacral Pedicle Screw System 355 OLO Orthopedic Stereotaxic Instrument 331 LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented 323 MBI Fastener, Fixation, Nondegradable, Soft Tissue 301 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 286 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented 276 HSB Rod, Fixation, Intramedullary And Accessories 257 KWQ Appliance, Fixation, Spinal Intervertebral Body 210 MQV Filler, Bone Void, Calcium Compound 186 KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component 175 ODP Intervertebral Fusion Device With Bone Graft, Cervical 169