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
7949 Orthopedic devices
6226–6250 of 7949
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043 · Wrightmedicaltechnologyinc
JDL · Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) · 196d
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
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 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 28, 2001
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT
K011047 · DePuy Orthopaedics, Inc.
MBF · Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented · 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
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 83d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa)
JDQ · Cerclage, Fixation · 90d
Cleared Jun 27, 2001
ORTHOGENESIS LPS SYSTEM
K003182 · Depuy, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 259d
Cleared Jun 19, 2001
ARTHREX BIO-TRANSFIX
K011172 · Arthrex, Inc.
MNU · Staple, Absorbable · 63d
Cleared Jun 19, 2001
RESORBABLE HAMMERTOE PIN
K011137 · Biomet, Inc.
JDW · Pin, Fixation, Threaded · 67d
Cleared Jun 19, 2001
KSEA MINIATURE TELESCOPE AND ACCESSORIES
K010987 · KARL STORZ Endoscopy-America, Inc.
HRX · Arthroscope · 78d
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 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · Howmedica Osteonics Corp.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 21d
Cleared Jun 15, 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS
K011622 · Howmedica Osteonics Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 21d
Cleared Jun 15, 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · DePuy Orthopaedics, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 42d
Cleared Jun 13, 2001
WORLAND UNICONDYLAR TIBIAL BEARING
K011795 · Biomet, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 5d
Cleared Jun 13, 2001
BARRETT UNICONDYLAR TIBIAL BEARING
K011509 · Biomet, Inc.
HRY · Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer · 28d
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

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All categories 7949 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 367 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