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
17716 Orthopedic devices
12776–12800 of 17716
Cleared Oct 10, 2001
DURACON PS LIPPED TIBIAL INSERT
K012172 · Howmedica Osteonics
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 90d
Cleared Oct 10, 2001
DISCOVERY ELBOW
K013042 · Biomet Orthopedics, Inc.
JDC · Prosthesis, Elbow, Constrained, Cemented · 30d
Cleared Oct 09, 2001
MONARCH SPINAL SYSTEMS
K013294 · Depuyacromed
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 7d
Cleared Oct 09, 2001
TIMX SPINAL SYSTEMS
K013295 · Depuyacromed
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 7d
Cleared Oct 09, 2001
MOSS MIAMI SPINAL SYSTEMS
K013296 · Depuyacromed
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 7d
Cleared Oct 05, 2001
ISOLA SPINAL SYSTEMS
K012971 · Depuyacromed
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 30d
Cleared Oct 04, 2001
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
K012967 · Disco-O-Tech Medical Technologies, Ltd.
HSB · Rod, Fixation, Intramedullary And Accessories · 30d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · Medtronic Sofamor Danek, Inc.
JDK · Prosthesis, Hip, Cement Restrictor · 27d
Cleared Oct 03, 2001
PRO-FEMUR
K012091 · Wrightmedicaltechnologyinc
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 90d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · Medtronic Sofamor Danek, Inc.
JDR · Staple, Fixation, Bone · 90d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 295d
Cleared Sep 28, 2001
SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K012114 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 84d
Cleared Sep 28, 2001
DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM
K012173 · Sulzer Spine-Tech
KWP · Appliance, Fixation, Spinal Interlaminal · 78d
Cleared Sep 28, 2001
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · Stryker Endoscopy
JDW · Pin, Fixation, Threaded · 71d
Cleared Sep 27, 2001
PF2
K012062 · Fixano SA
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 87d
Cleared Sep 27, 2001
RADIOFIX
K012078 · Fixano SA
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 87d
Cleared Sep 26, 2001
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
K012866 · Implex Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 30d
Cleared Sep 24, 2001
AOS MODULAR FEMORAL NAIL
K012190 · Advanced Orthopaedic Solutions, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 73d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870 · Howmedica Osteonics Corp.
KWP · Appliance, Fixation, Spinal Interlaminal · 28d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
K000122 · Neucoll, Inc.
MQV · Filler, Bone Void, Calcium Compound · 611d
Cleared Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · Kensey Nash Corp.
LZN · Cement Obturator · 90d
Cleared Sep 19, 2001
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · Sulzer Orthopedics, Inc.
HSX · Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer · 89d
Cleared Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · Bionx Implants, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 57d
Cleared Sep 17, 2001
OPUS MAGNUM ANCHOR & INSERTER
K012125 · Opus Medical, Inc.
HTY · Pin, Fixation, Smooth · 73d
Cleared Sep 14, 2001
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · Biomet Manufacturing, Inc.
HSD · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · 192d

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All categories 17716 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