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
17700 Orthopedic devices
11876–11900 of 17700
Cleared Dec 03, 2003
Z-SERIES MODULAR TOTAL HIP SYSTEM
K032729 · Osteoimplant Technology, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 91d
Cleared Dec 03, 2003
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM
K032752 · R&B Surgical Solutions, LLC
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 89d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · Medtronic Sofamor Danek, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 28d
Cleared Dec 03, 2003
MODIFICATION TO TELEGRAPH HUMERAL NAIL
K033510 · Fournitures Hospitalieres Industrie
HSB · Rod, Fixation, Intramedullary And Accessories · 27d
Cleared Dec 03, 2003
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · DePuy Orthopaedics, Inc.
HSD · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · 26d
Cleared Dec 03, 2003
TIE-IN TRAPEZIUM
K033529 · Wrightmedicaltechnologyinc
KYI · Prosthesis, Wrist, Carpal Trapezium · 23d
Cleared Dec 03, 2003
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635 · Ebi, L.P.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 14d
Cleared Dec 02, 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · Etex Corp.
MQV · Filler, Bone Void, Calcium Compound · 63d
Cleared Nov 28, 2003
TRIHA +
K031826 · Teknimed, S.A.
MQV · Filler, Bone Void, Calcium Compound · 168d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509 · Smith & Nephew, Inc.
LOD · Bone Cement · 22d
Cleared Nov 26, 2003
ORTHOSPHERE CERAMIC SPHERICAL IMPLANT
K030319 · Wrightmedicaltechnologyinc
KWD · Prosthesis, Toe, Hemi-, Phalangeal · 300d
Cleared Nov 26, 2003
CEMSTOP CEMENT RESTRICTOR
K032685 · Teknimed, S.A.
LZN · Cement Obturator · 89d
Cleared Nov 26, 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
K033411 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 30d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442 · Smith & Nephew, Inc.
KWZ · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer · 28d
Cleared Nov 20, 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · Ortho Tec, LLC
MNI · Orthosis, Spinal Pedicle Fixation · 238d
Cleared Nov 20, 2003
SCORPIO NRG KNEE SYSTEM
K030978 · Howmedica Osteonics Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 237d
Cleared Nov 20, 2003
GROWTH GUIDANCE PLATE
K031493 · University of Utah/School of Medicine
HRS · Plate, Fixation, Bone · 192d
Cleared Nov 20, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K032286 · Biomet Orthopedics, Inc.
MQV · Filler, Bone Void, Calcium Compound · 119d
Cleared Nov 20, 2003
UCR SPINAL SYSTEM
K032739 · Seaspine
MNI · Orthosis, Spinal Pedicle Fixation · 77d
Cleared Nov 20, 2003
BI-ANGULAR SHOULDER SYSTEM
K032895 · Biomet, Inc.
MBF · Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented · 64d
Cleared Nov 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
K033384 · Implex Corp.
JDK · Prosthesis, Hip, Cement Restrictor · 27d
Cleared Nov 18, 2003
DELTA SHOULDER
K021478 · Depuy, Inc.
PHX · Shoulder Prosthesis, Reverse Configuration · 559d
Cleared Nov 18, 2003
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS
K031666 · Arthrex, Inc.
HRS · Plate, Fixation, Bone · 173d
Cleared Nov 14, 2003
CLICK'X MONOAXIAL SCREWS AND HOOKS
K031175 · Synthes (Usa)
KWP · Appliance, Fixation, Spinal Interlaminal · 214d
Cleared Nov 14, 2003
PASSMED SPINAL SYSTEM
K032094 · Medicrea
KWP · Appliance, Fixation, Spinal Interlaminal · 130d

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All categories 17700 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 642 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