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
12851–12875 of 17716
Cleared Jul 25, 2001
EBI XFIX DFS SYSTEM
K012024 · Ebi, L.P.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 27d
Cleared Jul 23, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · Endius, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 41d
Cleared Jul 20, 2001
ARTHROSCOPES
K003831 · Global Endoscopy, Inc.
HRX · Arthroscope · 221d
Cleared Jul 20, 2001
MACROPORE OS SPINAL SYSTEM
K010911 · Macropore Biosurgery, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 116d
Cleared Jul 20, 2001
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K011118 · Osteomedics
HRS · Plate, Fixation, Bone · 99d
Cleared Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · Stryker Endoscopy
JDW · Pin, Fixation, Threaded · 80d
Cleared Jul 20, 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · Biomet, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 22d
Cleared Jul 20, 2001
MODIFICATION TO XIA SPINE SYSTEM
K012027 · Howmedica Osteonics
MNH · Orthosis, Spondylolisthesis Spinal Fixation · 22d
Cleared Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
K004003 · Interpore Cross Intl.
MQV · Filler, Bone Void, Calcium Compound · 206d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)
K011904 · Implex Corp.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 30d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969 · Synthes (Usa)
KWP · Appliance, Fixation, Spinal Interlaminal · 24d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · United States Surgical, A Division of Tyco Healthc
MQP · Spinal Vertebral Body Replacement Device · 229d
Cleared Jul 18, 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K010681 · Depuyacromed
KWP · Appliance, Fixation, Spinal Interlaminal · 133d
Cleared Jul 18, 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455 · Biomet, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 68d
Cleared Jul 18, 2001
1.5MM BONE FIXATION KIT
K012000 · Bionx Implants, Ltd.
HWC · Screw, Fixation, Bone · 21d
Cleared Jul 18, 2001
SMARTSCREW
K012001 · Bionx Implants, Ltd.
HWC · Screw, Fixation, Bone · 21d
Cleared Jul 18, 2001
TRIDENT ALL POLY CUP
K012026 · Howmedica Osteonics Corp.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 20d
Cleared Jul 16, 2001
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
K011076 · Walter Lorenz Surgical, Inc.
HRS · Plate, Fixation, Bone · 98d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · Exactech, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 21d
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043 · Wrightmedicaltechnologyinc
JDL · Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) · 196d
Cleared Jul 13, 2001
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
K010051 · Xiros Plc
JDR · Staple, Fixation, Bone · 186d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910 · American Medical Systems, Inc.
HWC · Screw, Fixation, Bone · 24d
Cleared Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · Tornier
HSD · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · 22d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · Howmedica Osteonics Corp.
LXT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite · 22d
Cleared Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · Biocomposites, Ltd.
MQV · Filler, Bone Void, Calcium Compound · 203d

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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