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
17749 Orthopedic devices
15726–15750 of 17749
Cleared Jul 26, 1993
OGDEN ANCHOR
K924367 · Advanced Surgical Implants, Inc.
JDR · Staple, Fixation, Bone · 332d
Cleared Jul 26, 1993
ACE UNIVERSAL RECONSTRUCTION PLATE
K930592 · Ace Medical Co.
HRS · Plate, Fixation, Bone · 172d
Cleared Jul 26, 1993
ACUTRACT
K930834 · Acu Med, Inc.
HWC · Screw, Fixation, Bone · 159d
Cleared Jul 23, 1993
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
K921182 · Biomet, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 500d
Cleared Jul 22, 1993
3M MODULAR SHOULDER SYSTEM
K920362 · 3M Health Care, Ltd.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 541d
Cleared Jul 22, 1993
MEDNEXT 1000 BONE DISSECTING SYSTEM
K926547 · Mednext, Inc.
HSZ · Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment · 203d
Cleared Jul 21, 1993
ACUFEX(R) TAG(TM)
K911293 · Acufex Microsurgical, Inc.
JDR · Staple, Fixation, Bone · 849d
Cleared Jul 21, 1993
CONSENSUS(TM) TOTAL HIP SYSTEM
K922561 · U.S. Medical Products, Inc.
JDL · Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) · 413d
Cleared Jul 13, 1993
FPC/SFPC/RFPC ACETABULAR COMPONENT
K915529 · Implantology Corp.
JDL · Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) · 581d
Cleared Jul 13, 1993
TOTAL CONDYLAT TYPE KNEE SYSTEM
K922869 · Osteo Technology, Inc.
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 404d
Cleared Jul 13, 1993
OTI EUROPEAN COMPRESSION SYSTEM
K925571 · Osteo-Technology Intl., Inc.
HRS · Plate, Fixation, Bone · 252d
Cleared Jul 09, 1993
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc.
HTY · Pin, Fixation, Smooth · 402d
Cleared Jul 02, 1993
SEIDEL HUMERAL LOCKING NAIL
K931256 · Howmedica Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 112d
Cleared Jun 29, 1993
BHR BIPOLAR FEMORAL HEAD COMPONENT
K915528 · Implantology Corp.
LZY · Prosthesis, Hip, Hemi-, Femoral, Metal Ball · 567d
Cleared Jun 29, 1993
ARTHROSCOPE & ACCESSORIES
K921985 · Optimed Technologies, Inc.
HRX · Arthroscope · 427d
Cleared Jun 29, 1993
OTI ORTHOPEDIC WIRE SYSTEM
K925447 · Osteo Technology, Inc.
JDQ · Cerclage, Fixation · 244d
Cleared Jun 24, 1993
CPS ACETABULAR COMPONENT
K915527 · Implantology Corp.
JDL · Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) · 562d
Cleared Jun 24, 1993
COTREL - DUBOUSSET SPINE IMPLANTS
K921056 · Buckman Co., Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 476d
Cleared Jun 24, 1993
SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS
K922855 · Synthes (Usa)
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 374d
Cleared Jun 22, 1993
WALKER HIP PROSTHESIS
K915222 · Zimmer, Inc.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 580d
Cleared Jun 22, 1993
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767 · Buckman Co., Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 434d
Cleared Jun 22, 1993
SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST
K921948 · Synthes (Usa)
KWP · Appliance, Fixation, Spinal Interlaminal · 421d
Cleared Jun 22, 1993
SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
K923613 · Synthes (Usa)
JDO · Device, Fixation, Proximal Femoral, Implant · 336d
Cleared Jun 17, 1993
MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM
K926213 · Osteo Technology, Inc.
HSB · Rod, Fixation, Intramedullary And Accessories · 189d
Cleared Jun 17, 1993
ALTA CFX ROD SYSTEM
K926232 · Howmedica Corp.
HSB · Rod, Fixation, Intramedullary And Accessories · 188d

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All categories 17749 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 650 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 552 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 424