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
7793 Orthopedic devices
4976–5000 of 7793
Cleared Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K111400 · Exactech, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 70d
Cleared Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · Synthes (Usa)
JDQ · Cerclage, Fixation · 128d
Cleared Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · Synthes (Usa)
HWC · Screw, Fixation, Bone · 145d
Cleared Jul 21, 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201 · Biomet, Inc.
HRS · Plate, Fixation, Bone · 178d
Cleared Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · Exactech, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 172d
Cleared Jul 12, 2011
ORTHOSORB RESORBABLE PINS
K111077 · DePuy Orthopaedics, Inc.
OVZ · Pin, Fixation, Resorbable, Hard Tissue · 85d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
K110670 · Smith & Nephew, Inc.
HRS · Plate, Fixation, Bone · 125d
Cleared Jul 01, 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · Smith & Nephew, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 79d
Cleared Jul 01, 2011
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
K110940 · Zimmer, Inc.
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 88d
Cleared Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · Exactech, Inc.
ODP · Intervertebral Fusion Device With Bone Graft, Cervical · 197d
Cleared Jun 24, 2011
SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)
K110545 · Smith & Nephew, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 119d
Cleared Jun 22, 2011
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · DePuy Orthopaedics, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 29d
Cleared Jun 08, 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
K111379 · Exactech, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 22d
Cleared May 19, 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039 · Zimmer, Inc.
HRS · Plate, Fixation, Bone · 35d
Cleared May 17, 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · Exactech, Inc.
KWT · Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented · 64d
Cleared May 10, 2011
GLADIATOR PLASMA CLASSIC HIP STEM
K110399 · Wrightmedicaltechnologyinc
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 88d
Cleared May 05, 2011
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C
K103835 · Howmedica Osteonics Corp.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 126d
Cleared May 04, 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · Wrightmedicaltechnologyinc
HWC · Screw, Fixation, Bone · 260d
Cleared Apr 28, 2011
PCL TIGHTROPE
K110123 · Arthrex, Inc.
HTY · Pin, Fixation, Smooth · 100d
Cleared Apr 22, 2011
REVISION PROTHESIS
K110837 · Smith & Nephew, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 28d
Cleared Apr 21, 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 93d
Cleared Apr 19, 2011
CONSERVE BIO FOAM SHELL
K110029 · Wrightmedicaltechnologyinc
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 104d
Cleared Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662 · Zimmer, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 121d
Cleared Apr 14, 2011
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
K110240 · Smith & Nephew, Inc.
OLO · Orthopedic Stereotaxic Instrument · 77d
Cleared Apr 11, 2011
TAPER OXINIUM FEMORAL HEAD
K110101 · Smith & Nephew, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 88d

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All categories 7793 HRS Plate, Fixation, Bone 695 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 501 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 406 HWC Screw, Fixation, Bone 398 NKB Thoracolumbosacral Pedicle Screw System 350 OLO Orthopedic Stereotaxic Instrument 330 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 281 HSB Rod, Fixation, Intramedullary And Accessories 257 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented 257 KWQ Appliance, Fixation, Spinal Intervertebral Body 207 MQV Filler, Bone Void, Calcium Compound 183 KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component 175 ODP Intervertebral Fusion Device With Bone Graft, Cervical 168