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
12676–12700 of 17714
Cleared Dec 20, 2001
LORENZ LACTOSORB PANELS AND FASTENERS
K011139 · Biomet, Inc.
HRS · Plate, Fixation, Bone · 251d
Cleared Dec 20, 2001
NORIAN SRS BONE VOID FILLER
K011897 · Synthes (Usa)
MQV · Filler, Bone Void, Calcium Compound · 185d
Cleared Dec 20, 2001
SIGN IM NAIL
K013132 · Surgical Implant Generation Network (Sign)
HSB · Rod, Fixation, Intramedullary And Accessories · 92d
Cleared Dec 20, 2001
RT-PLUS KNEE ADDITIONAL COMPONENTS
K013340 · Plus Orthopedics
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 72d
Cleared Dec 20, 2001
INTRAMEDULLARY FIXATION SYSTEM FOR THE HAND
K013424 · Hand Innovations, Inc.
HTY · Pin, Fixation, Smooth · 66d
Cleared Dec 20, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · Howmedica Osteonics Corp.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 62d
Cleared Dec 19, 2001
SYNTHES LCP DISTAL TIBIA PLATES
K013248 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 82d
Cleared Dec 19, 2001
MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
K013449 · Disc-O-Tech Medical Technologies, Ltd.
HSB · Rod, Fixation, Intramedullary And Accessories · 63d
Cleared Dec 19, 2001
PRE-LOADED ULTRAFIX RC
K013553 · Linvatec Corp.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 55d
Cleared Dec 19, 2001
POLARUS CAP SCREW
K013616 · Acu Med, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 44d
Cleared Dec 19, 2001
XIA SPINAL SYSTEM
K013823 · Howmedica Osteonics Corp.
KWP · Appliance, Fixation, Spinal Interlaminal · 30d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · Medtronic Sofamor Danek, Inc.
MRW · System, Facet Screw Spinal Device · 30d
Cleared Dec 19, 2001
CODMAN SLIM-LOC SYSTEM
K013877 · Codman & Shurtleff, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 26d
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
GENERATION 4 BONE CEMENT
K993836 · Biomet, Inc.
LOD · Bone Cement · 768d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352 · DePuy Orthopaedics, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 69d
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
SELF-COUNTERSINKING BONE SCREW
K013534 · Biomet Orthopedics, Inc.
HWC · Screw, Fixation, Bone · 55d
Cleared Dec 17, 2001
DRG ORTHOHEX SS BONE SCREW
K013786 · Doctor'S Research Group, Inc.
HWC · Screw, Fixation, Bone · 33d
Cleared Dec 17, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
K013903 · Triad Medical, Inc.
HWC · Screw, Fixation, Bone · 21d
Cleared Dec 13, 2001
SPINE SCOPE, MODEL 2180
K011454 · Clarus Medical, LLC
HRX · Arthroscope · 216d
Cleared Dec 13, 2001
3D HUMERAL HEADS
K012378 · Smith & Nephew, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 140d
Cleared Dec 13, 2001
ENDOFLIP
K013334 · Arthocare Corporation
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 65d
Cleared Dec 13, 2001
MODIFICATION TO EBI XFIX DFS SYSTEM
K013739 · Ebi, L.P.
LXT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite · 30d
Cleared Dec 13, 2001
ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
K013935 · Sulzer Orthopedics, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 15d

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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