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
12801–12825 of 17716
Cleared Sep 14, 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · Biomet Orthopedics, Inc.
HSD · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · 178d
Cleared Sep 13, 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
K012871 · Interpore Cross Intl.
KWP · Appliance, Fixation, Spinal Interlaminal · 17d
Cleared Sep 12, 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · Synthes (Usa)
HSB · Rod, Fixation, Intramedullary And Accessories · 90d
Cleared Sep 11, 2001
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
K010303 · Artscan Medical Innovations
NGR · Tester, Stiffness, Cartilage, Arthroscopic · 280d
Cleared Sep 07, 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · Depuy, Inc.
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 88d
Cleared Sep 07, 2001
MPF ACETABULAR CUP
K011836 · Plus Orthopedics
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 87d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · Synthes (Usa)
KTW · Appliance, Fixation, Nail/blade/plate Combination, Single Component · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · New Deal, S.A.
HWC · Screw, Fixation, Bone · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE TAC' PIN
K011875 · New Deal, S.A.
JDW · Pin, Fixation, Threaded · 83d
Cleared Sep 05, 2001
R120 MODULAR TOTAL HIP SYSTEM
K011774 · Osteoimplant Technology, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 90d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · Axya Medical, Inc.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 73d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · Howmedica Osteonics Corp.
HRS · Plate, Fixation, Bone · 51d
Cleared Aug 30, 2001
THE UNI-CLIP STAPLE
K011716 · New Deal, S.A.
JDR · Staple, Fixation, Bone · 87d
Cleared Aug 30, 2001
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
K012507 · Implex Corp.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 24d
Cleared Aug 29, 2001
VULCAN TAC PROBES, MODEL 911XXX
K003198 · Oratec Interventions, Inc.
HRX · Arthroscope · 321d
Cleared Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · Exactech, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 26d
Cleared Aug 27, 2001
MACROPORE IB RESORBABLE PLUG
K011715 · Macropore Biosurgery, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 84d
Cleared Aug 24, 2001
THE SPIN SNAP-OFF SCREW
K011946 · New Deal, S.A.
HWC · Screw, Fixation, Bone · 64d
Cleared Aug 24, 2001
FLEX-NAILS
K012161 · Fixano SA
HTY · Pin, Fixation, Smooth · 44d
Cleared Aug 22, 2001
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
K012305 · Sulzer Spine-Tech
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 30d
Cleared Aug 20, 2001
INTERLOK / HA COPELAND RESURFACING HEADS
K010635 · Biomet, Inc.
MBF · Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented · 171d
Cleared Aug 17, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
K012280 · Triage Medical, Inc.
HWC · Screw, Fixation, Bone · 29d
Cleared Aug 15, 2001
VHS PEDIATRIC HIP SCREW SYSTEM
K011603 · Walter Abendschein, M.D.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 83d
Cleared Aug 15, 2001
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
K012212 · Tornier
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 30d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · United States Surgical, A Division of Tyco Healthc
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 27d

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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