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
17701 Orthopedic devices
12076–12100 of 17701
Cleared Jun 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585 · U&I Corp., America
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 37d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · Medtronic Sofamor Danek USA, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 30d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · Medtronic Sofamor Danek
MNI · Orthosis, Spinal Pedicle Fixation · 9d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · Blackstone Medical, Inc.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 122d
Cleared Jun 26, 2003
MINILOK QUICKANCHOR PLUS
K030995 · Mitek Worldwide
HWC · Screw, Fixation, Bone · 87d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · Walter Lorenz Surgical, Inc.
HWC · Screw, Fixation, Bone · 21d
Cleared Jun 25, 2003
EBI XFIX DFS SYSTEM
K031645 · Ebi, L.P.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 28d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 96d
Cleared Jun 24, 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154 · Sintea Biotech, Inc.
JDW · Pin, Fixation, Threaded · 74d
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572 · Zimmer, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 35d
Cleared Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595 · U&I Corp., America
KWP · Appliance, Fixation, Spinal Interlaminal · 34d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · Synthes (Usa)
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 21d
Cleared Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
K031635 · Depuyacromed
MQP · Spinal Vertebral Body Replacement Device · 27d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · Inion , Ltd.
HWC · Screw, Fixation, Bone · 87d
Cleared Jun 18, 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · Ortho Tec, LLC
KWP · Appliance, Fixation, Spinal Interlaminal · 42d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · Smith & Nephew, Inc.
HRX · Arthroscope · 27d
Cleared Jun 13, 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 28d
Cleared Jun 12, 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · Blackstone Medical, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 142d
Cleared Jun 12, 2003
OTI BONE CEMENT PLUG
K030608 · Osteoimplant Technology, Inc.
JDK · Prosthesis, Hip, Cement Restrictor · 106d
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · Biomet, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 86d
Cleared Jun 12, 2003
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
K031083 · Opus Medical, Inc.
HTY · Pin, Fixation, Smooth · 69d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · DePuy Orthopaedics, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 29d
Cleared Jun 10, 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
K030519 · Hand Biomechanics Lab, Inc.
JEC · Component, Traction, Invasive · 111d
Cleared Jun 09, 2003
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
K031609 · Swiss Orthopedic Solutions, Inc.
HRS · Plate, Fixation, Bone · 18d
Cleared Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816 · Medtronic Sofamor Danek
KWP · Appliance, Fixation, Spinal Interlaminal · 84d

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All categories 17701 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 643 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