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
7954 Orthopedic devices
6251–6275 of 7954
Cleared Jun 12, 2001
T2 HUMERAL NAIL SYSTEM
K011529 · Howmedica Osteonics Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 26d
Cleared Jun 12, 2001
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55
K011007 · Arthrex, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 69d
Cleared Jun 12, 2001
TROCHANTERIC NAIL
K010780 · DePuy Orthopaedics, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 89d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 90d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · Synthes (Usa)
MNI · Orthosis, Spinal Pedicle Fixation · 90d
Cleared May 30, 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 173d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · Smith & Nephew, Inc.
MQV · Filler, Bone Void, Calcium Compound · 88d
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · Biomet, Inc.
HRS · Plate, Fixation, Bone · 30d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc.
HWC · Screw, Fixation, Bone · 90d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 90d
Cleared May 18, 2001
ASCENT KNEE SYSTEM
K011219 · Biomet, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 28d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · Exactech, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 26d
Cleared May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · Arthrex, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 87d
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · Aesculap, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 239d
Cleared May 04, 2001
APEX FIXATION PINS
K011136 · Howmedica Osteonics Corp.
JDW · Pin, Fixation, Threaded · 21d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 87d
Cleared May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · Synthes (Usa)
KTW · Appliance, Fixation, Nail/blade/plate Combination, Single Component · 89d
Cleared Apr 27, 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · Aesculap, Inc.
HRX · Arthroscope · 144d
Cleared Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · Exactech, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 14d
Cleared Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · Synthes (Usa)
MQP · Spinal Vertebral Body Replacement Device · 186d
Cleared Apr 18, 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · Howmedica Osteonics Corp.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 28d
Cleared Apr 18, 2001
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
K010810 · DePuy Orthopaedics, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 30d
Cleared Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · Howmedica Osteonics Corp.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 90d
Cleared Apr 16, 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · Howmedica Osteonics Corp.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 90d
Cleared Apr 13, 2001
AVL HINGE KNEE SYSTEM
K010774 · Biomet, Inc.
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 30d

Looking for a specific orthopedic device? Search by device name, K-number or manufacturer.

Search all Orthopedic 510(k) devices

Filter by Product Code

All categories 7954 HRS Plate, Fixation, Bone 695 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 516 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 418 HWC Screw, Fixation, Bone 401 NKB Thoracolumbosacral Pedicle Screw System 368 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 216 MQV Filler, Bone Void, Calcium Compound 190 KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component 175 ODP Intervertebral Fusion Device With Bone Graft, Cervical 170