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
17721 Orthopedic devices
13051–13075 of 17721
Cleared Jan 29, 2001
COLLES C SERIES FRAME STERILE PACK
K003397 · DePuy Orthopaedics, Inc.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 89d
Cleared Jan 26, 2001
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
K002652 · Stryker Corp.
LOD · Bone Cement · 154d
Cleared Jan 25, 2001
FMP METAL/METAL ACETABULAR INSERT
K003250 · Encore Orthopedics, Inc.
KWA · Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) · 100d
Cleared Jan 25, 2001
IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
K004013 · Implex Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 29d
Cleared Jan 24, 2001
PARSFIX CABLE-SCREW SYSTEM
K003351 · Spinal Concepts, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 90d
Cleared Jan 19, 2001
OTI CERAMIC FEMORAL HEAD SYSTEM
K003316 · Osteoimplant Technology, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 88d
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · Medtronic Sofamor Danek, Inc.
MRW · System, Facet Screw Spinal Device · 28d
Cleared Jan 12, 2001
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253 · Biomet, Inc.
JDC · Prosthesis, Elbow, Constrained, Cemented · 87d
Cleared Jan 12, 2001
CONTOUR LABRAL NAIL, MODEL 533520A
K003970 · Bionx Implants, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 21d
Cleared Jan 12, 2001
MAXIM KNEE SYSTEM
K010027 · Biomet, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 9d
Cleared Jan 11, 2001
LACTOSORB SCREW ANCHOR
K003273 · Biomet, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 85d
Cleared Jan 11, 2001
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · Howmedica Osteonics Corp.
JEC · Component, Traction, Invasive · 30d
Cleared Jan 10, 2001
TRIAD II MODULAR TOTAL HIP SYSTEM
K003199 · Osteoimplant Technology, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 90d
Cleared Jan 10, 2001
U2 HIP STEM, TI POROUS COATED
K003237 · United Orthopedic Corp.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 85d
Cleared Jan 08, 2001
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
K003227 · Arthrex, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 84d
Cleared Jan 08, 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822 · Depuyacromed
KWP · Appliance, Fixation, Spinal Interlaminal · 28d
Cleared Jan 04, 2001
VERTEBRAL BODY REPLACEMENT
K003155 · Osteotech, Inc.
MQP · Spinal Vertebral Body Replacement Device · 86d
Cleared Jan 04, 2001
UNICONDYLAR INTERPOSITIONAL SPACER
K003269 · Sulzer Orthopedics, Inc.
HSH · Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) · 78d
Cleared Jan 04, 2001
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM
K003832 · Sulzer Orthopedics, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 24d
Cleared Jan 04, 2001
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
K003898 · Ebi, L.P.
HRX · Arthroscope · 17d
Cleared Jan 02, 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · Ebi, L.P.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 27d
Cleared Dec 29, 2000
BIOMET EXTERNAL WRIST PLATE
K003240 · Biomet, Inc.
LXT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite · 73d
Cleared Dec 28, 2000
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212 · Disco-O-Tech Medical Technologies, Ltd.
JDS · Nail, Fixation, Bone · 76d
Cleared Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215 · Disco-O-Tech Medical Technologies, Ltd.
JDS · Nail, Fixation, Bone · 75d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · Medtronic Sofamor Danek, Inc.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 301d

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All categories 17721 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 550 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