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
17720 Orthopedic devices
12976–13000 of 17720
Cleared Apr 17, 2001
WUJIN #3 FEMORAL NAIL
K010149 · Biopro, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 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
Cleared Apr 12, 2001
MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010742 · Depuyacromed
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 30d
Cleared Apr 11, 2001
SOCON SPINAL SYSTEM
K003463 · Aesculap, Inc.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 155d
Cleared Apr 11, 2001
TSRH SPINAL SYSTEM
K010720 · Medtronic Sofamor Danek, Inc.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 30d
Cleared Apr 11, 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757 · Howmedica Osteonics Corp.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 29d
Cleared Apr 11, 2001
ULNAR HEAD IMPLANT
K010786 · Avanta Orthopaedics, Inc.
KXE · Prosthesis, Wrist, Hemi-, Ulnar · 27d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · Synthes (Usa)
HTY · Pin, Fixation, Smooth · 144d
Cleared Apr 06, 2001
LPC-PLUS ACETABULAR CUP
K003274 · Plus Orthopedics
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 170d
Cleared Apr 06, 2001
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · Howmedica Osteonics Corp.
KRR · Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer · 85d
Cleared Apr 06, 2001
ARTHREX UNIVERS 30 SHOULDER PROSTHESIS
K010124 · Arthrex, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 80d
Cleared Apr 06, 2001
DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER
K010171 · DePuy Orthopaedics, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 78d
Cleared Apr 06, 2001
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
K010776 · Corin USA
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 23d
Cleared Apr 06, 2001
T2 FEMORAL NAIL
K010801 · Howmedica Osteonics Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 21d
Cleared Apr 05, 2001
COPELAND RESURFACING HUMERAL HEADS
K010664 · Biomet Manufacturing, Inc.
HSD · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · 30d
Cleared Apr 02, 2001
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
K010685 · Zimmer, Inc.
HSX · Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer · 25d
Cleared Mar 26, 2001
DJ ORTHOPEDICS FEMORAL ANCHOR
K002829 · Dj Orthopedics, LLC
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 196d
Cleared Mar 22, 2001
MODIFICATION TO SYNERGY SPINAL SYSTEM
K010515 · Interpore Cross Intl.
KWP · Appliance, Fixation, Spinal Interlaminal · 28d
Cleared Mar 21, 2001
PECTOFIX STERNAL REPAIR WIRE
K003951 · Pectofix, Inc.
JDQ · Cerclage, Fixation · 90d
Cleared Mar 21, 2001
DJ ORTHOPEDICS TIBIAL ANCHOR
K003960 · Dj Orthopedics, LLC
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 90d
Cleared Mar 21, 2001
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
K003971 · Axya Medical, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 89d
Cleared Mar 20, 2001
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
K001535 · Ortho Tec, LLC
KWP · Appliance, Fixation, Spinal Interlaminal · 307d
Cleared Mar 20, 2001
LACTOSORB 5.0 MM WASHER
K001581 · Biomet, Inc.
HWC · Screw, Fixation, Bone · 302d
Cleared Mar 20, 2001
APEX MODULAR ZIRCONIA FEMORAL HEAD
K003923 · Apex Surgical, LLC
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 90d

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All categories 17720 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 646 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