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
17717 Orthopedic devices
12876–12900 of 17717
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823 · Ortho Tec, LLC
KWP · Appliance, Fixation, Spinal Interlaminal · 212d
Cleared Jul 11, 2001
SIGN IM NAIL
K011129 · Sign, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 89d
Cleared Jul 10, 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138 · Biomet, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 88d
Cleared Jul 06, 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · DePuy Orthopaedics, Inc.
MBF · Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented · 86d
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · Osteomed Corp.
HWC · Screw, Fixation, Bone · 97d
Cleared Jul 05, 2001
SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
K011170 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 79d
Cleared Jul 02, 2001
M2A ACETABULAR SYSTEM
K011110 · Biomet, Inc.
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 82d
Cleared Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · Plus Orthopedics
HWC · Screw, Fixation, Bone · 28d
Cleared Jun 29, 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711 · Ebi, L.P.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 25d
Cleared Jun 28, 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · DePuy Orthopaedics, Inc.
MBF · Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented · 83d
Cleared Jun 28, 2001
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND
K011083 · Arthrocare Corp.
HRX · Arthroscope · 79d
Cleared Jun 28, 2001
SCORPIO CR SUPERFLEX TIBIAL INSERT
K011643 · Howmedica Osteonics Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 30d
Cleared Jun 27, 2001
ORTHOGENESIS LPS SYSTEM
K003182 · Depuy, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 259d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa)
JDQ · Cerclage, Fixation · 90d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 83d
Cleared Jun 27, 2001
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR
K011299 · Smith & Nephew, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 58d
Cleared Jun 27, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697 · Ebi, L.P.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 26d
Cleared Jun 20, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM
K010884 · Anchor Medical Technologies
HWC · Screw, Fixation, Bone · 89d
Cleared Jun 19, 2001
PFC SIGMA LUGGED TIBIAL TRAY
K003026 · DePuy Orthopaedics, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 264d
Cleared Jun 19, 2001
K'FIX
K010847 · Avanta Orthopaedics, Inc.
NDL · Pin, Fixation, Smooth, Metallic · 90d
Cleared Jun 19, 2001
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B
K010901 · Disc-O-Tech Medical Technologies, Ltd.
HSB · Rod, Fixation, Intramedullary And Accessories · 85d
Cleared Jun 19, 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · KARL STORZ Endoscopy-America, Inc.
HRX · Arthroscope · 78d
Cleared Jun 19, 2001
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
K010988 · Disc-O-Tech Medical Technologies, Ltd.
HSB · Rod, Fixation, Intramedullary And Accessories · 78d
Cleared Jun 19, 2001
RESORBABLE HAMMERTOE PIN
K011137 · Biomet, Inc.
JDW · Pin, Fixation, Threaded · 67d
Cleared Jun 19, 2001
ARTHREX BIO-TRANSFIX
K011172 · Arthrex, Inc.
MNU · Staple, Absorbable · 63d

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All categories 17717 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