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
17704 Orthopedic devices
12351–12375 of 17704
Cleared Oct 04, 2002
RHS ACETABULAR COMPONENT
K022382 · Signal Medical Corp.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 74d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · Smith & Nephew, Inc.
HWC · Screw, Fixation, Bone · 23d
Cleared Oct 04, 2002
NUGEN FX SCREW
K023022 · Bionx Implants, Inc.
HWC · Screw, Fixation, Bone · 23d
Cleared Oct 04, 2002
CLASSIC GREAT TOE IMPLANT
K023086 · Nexa Orthopedics, Inc.
KWH · Prosthesis, Toe, Constrained, Polymer · 17d
Cleared Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · Arthrex, Inc.
HWC · Screw, Fixation, Bone · 84d
Cleared Oct 02, 2002
ENDIUS ATAVI SYSTEM
K022199 · Endius, Inc.
HRX · Arthroscope · 89d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902 · Smith & Nephew, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 29d
Cleared Oct 02, 2002
TOTAL HIP FEMORAL HEADS AND LINERS
K022958 · Smith & Nephew, Inc.
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 26d
Cleared Oct 02, 2002
PROXILOCK HIP PROSTHESIS
K022966 · Implex Corp.
LWJ · Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented · 26d
Cleared Sep 26, 2002
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
K020457 · Axiamed, Inc.
HRX · Arthroscope · 227d
Cleared Sep 24, 2002
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · Biomet, Inc.
KWT · Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented · 90d
Cleared Sep 24, 2002
TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM
K022344 · Centerpulse Spine-Tech, Inc.
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 67d
Cleared Sep 24, 2002
CADENCE SPINAL FIXATION SYSTEM
K022374 · Sulzer Spine-Tech
KWP · Appliance, Fixation, Spinal Interlaminal · 64d
Cleared Sep 23, 2002
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
K021740 · Dj Orthopedics, LLC
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 118d
Cleared Sep 23, 2002
HIP TOOL IMPLANT
K022139 · Orthopedic Sciences, Inc.
HRS · Plate, Fixation, Bone · 83d
Cleared Sep 23, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K022271 · Spine Vision, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 72d
Cleared Sep 23, 2002
RESTORATION MODULAR SYSTEM
K022549 · Howmedica Osteonics Corp.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 53d
Cleared Sep 23, 2002
SIGN IM NAIL
K022632 · Surgical Implant Generation Network (Sign)
HSB · Rod, Fixation, Intramedullary And Accessories · 47d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · Smith & Nephew, Inc.
JEC · Component, Traction, Invasive · 42d
Cleared Sep 23, 2002
TWIN FIX
K022771 · Fixano SA
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 33d
Cleared Sep 18, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K022744 · Medical Device Services
HWE · Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment · 30d
Cleared Sep 18, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · Medtronic Sofamor Danek, Inc.
MNI · Orthosis, Spinal Pedicle Fixation · 27d
Cleared Sep 17, 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · Medtronic Sofamor Danek
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 111d
Cleared Sep 17, 2002
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
K022324 · Osteomedics, Inc.
HRS · Plate, Fixation, Bone · 62d
Cleared Sep 17, 2002
EXTERNAL FIXATION RING
K022423 · Rigid FX Orthopedics, Incorporated
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 55d

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All categories 17704 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 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 521 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 422