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
17714 Orthopedic devices
12651–12675 of 17714
Cleared Jan 25, 2002
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · Howmedica Osteonics Corp.
KWL · Prosthesis, Hip, Hemi-, Femoral, Metal · 30d
Cleared Jan 25, 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229 · Howmedica Osteonics Corp.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 30d
Cleared Jan 25, 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 29d
Cleared Jan 23, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · Blackstone Medical, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 90d
Cleared Jan 18, 2002
PLLA CANNULATED INTERFERENCE SCREW
K013685 · Future Medical Systems, Inc.
HWC · Screw, Fixation, Bone · 72d
Cleared Jan 17, 2002
CEMENTED CALCAR HIP SYSTEM
K013490 · Encore Orthopedics, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 87d
Cleared Jan 17, 2002
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
K013513 · Pain Concepts, Inc.
HRX · Arthroscope · 87d
Cleared Jan 17, 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
K014145 · Interpore Cross Intl.
MQP · Spinal Vertebral Body Replacement Device · 30d
Cleared Jan 17, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K014194 · Ebi, L.P.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 27d
Cleared Jan 16, 2002
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · Ebi, L.P.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 30d
Cleared Jan 15, 2002
PASS SPINAL SYSTEM
K013442 · Encore Orthopedics, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 90d
Cleared Jan 15, 2002
ISOBAR SPINAL SYSTEM
K013447 · Scien'Tx USA, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 90d
Cleared Jan 14, 2002
ANTERIOR CERVICAL PLATE SYSTEM
K013439 · Scien'Tx USA, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 89d
Cleared Jan 11, 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · Synthes (Usa)
HRS · Plate, Fixation, Bone · 88d
Cleared Jan 11, 2002
ACTAEON PROBE
K013429 · Osteobiologics, Inc.
NGR · Tester, Stiffness, Cartilage, Arthroscopic · 87d
Cleared Jan 09, 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · Zimmer, Inc.
KRO · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer · 89d
Cleared Jan 09, 2002
EPOCA CODR STEM AND HEAD
K014049 · Stelkast Company
KWT · Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented · 30d
Cleared Jan 08, 2002
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
K013775 · Stryker Leibinger
HRS · Plate, Fixation, Bone · 56d
Cleared Dec 31, 2001
MSI BIPOLAR SHEATH
K011202 · Medical Scientific, Inc.
HRX · Arthroscope · 256d
Cleared Dec 27, 2001
SPINAL MESH SYSTEM
K011406 · Medtronic Sofamor Danek, Inc.
MQP · Spinal Vertebral Body Replacement Device · 233d
Cleared Dec 27, 2001
AVALON CUP SYSTEM
K011887 · Orthopedic Source, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 192d
Cleared Dec 27, 2001
LONG TROCHANTERIC NAIL SYSTEM
K013563 · DePuy Orthopaedics, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 62d
Cleared Dec 27, 2001
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K013991 · Zimmer, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 23d
Cleared Dec 27, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · Medtronic Sofamor Danek, Inc.
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 16d
Cleared Dec 21, 2001
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · Synthes (Usa)
HTO · Reamer · 59d

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All categories 17714 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 644 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