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
17697 Orthopedic devices
11501–11525 of 17697
Cleared Oct 07, 2004
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
K042508 · Depuy Spine, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 22d
Cleared Oct 07, 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514 · Blackstone Medical, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 21d
Cleared Oct 05, 2004
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K041698 · Axya Medical, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 105d
Cleared Oct 05, 2004
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · Acumed, LLC
KWI · Prosthesis, Elbow, Hemi-, Radial, Polymer · 88d
Cleared Oct 04, 2004
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · Exactech, Inc.
KWZ · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer · 210d
Cleared Oct 01, 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · Exactech, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 179d
Cleared Oct 01, 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · Synthes Spine
MQP · Spinal Vertebral Body Replacement Device · 129d
Cleared Oct 01, 2004
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K041808 · Endius, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 87d
Cleared Oct 01, 2004
M2A MAGNUM SYSTEM
K042037 · Biomet, Inc.
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 64d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 28d
Cleared Sep 30, 2004
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K040630 · Implex Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 204d
Cleared Sep 30, 2004
SHOULDER FIXATION SYSTEM
K042059 · Hand Innovations, Inc.
LXT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite · 62d
Cleared Sep 24, 2004
ST360 SPINAL FIXATION SYSTEM
K041925 · Zimmer Spine, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 67d
Cleared Sep 24, 2004
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K042019 · Howmedica Osteonics Corp.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 59d
Cleared Sep 24, 2004
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
K042312 · Smith & Nephew, Inc.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 29d
Cleared Sep 24, 2004
CERVICAL PLATE
K042317 · Scient'X
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 29d
Cleared Sep 23, 2004
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
K041591 · Howmedica Osteonics Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 101d
Cleared Sep 23, 2004
MODIFICATION TO VBR SPINAL SYSTEM
K041722 · Depuy Spine, Inc.
MQP · Spinal Vertebral Body Replacement Device · 91d
Cleared Sep 21, 2004
ARTELON SPACER CMC-1
K040070 · Artimplant AB
KYI · Prosthesis, Wrist, Carpal Trapezium · 251d
Cleared Sep 20, 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100 · Blackstone Medical, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 47d
Cleared Sep 20, 2004
BONE FUSION PLATE SYSTEM
K042205 · Wrightmedicaltechnologyinc
HRS · Plate, Fixation, Bone · 35d
Cleared Sep 17, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042235 · Medtronic Sofamor Danek
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 30d
Cleared Sep 16, 2004
CORAL SPINAL SYSTEM
K041592 · Theken Surgical
KWP · Appliance, Fixation, Spinal Interlaminal · 94d
Cleared Sep 16, 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc
MQV · Filler, Bone Void, Calcium Compound · 90d
Cleared Sep 16, 2004
SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X
K041989 · Sintea Biotech, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 55d

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All categories 17697 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 640 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