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
17614 Orthopedic devices
8551–8575 of 17614
Cleared Feb 09, 2011
HAMMERLOC TM TIBIAL FIXATION DEVICE
K103145 · Biomet Sports Medicine
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 107d
Cleared Feb 08, 2011
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K103040 · Lanx, LLC
NKB · Thoracolumbosacral Pedicle Screw System · 118d
Cleared Feb 08, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K103102 · Phygen, LLC
MNI · Orthosis, Spinal Pedicle Fixation · 111d
Cleared Feb 08, 2011
TRILLIANT SURGICAL SUBTALAR IMPLANT
K103183 · Trilliant Surgical, Ltd.
HWC · Screw, Fixation, Bone · 103d
Cleared Feb 08, 2011
SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
K110069 · Smith & Nephew, Inc.
KTT · Appliance, Fixation, Nail/blade/plate Combination, Multiple Component · 29d
Cleared Feb 07, 2011
COROENT INTERLOCK SYSTEM
K102547 · Nuvasive, Inc.
OVE · Intervertebral Fusion Device With Integrated Fixation, Cervical · 157d
Cleared Feb 07, 2011
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
K103173 · Orthovita, Inc.
MQV · Filler, Bone Void, Calcium Compound · 102d
Cleared Feb 07, 2011
5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL
K110164 · Arthrocare Corp.
MBI · Fastener, Fixation, Nondegradable, Soft Tissue · 19d
Cleared Feb 04, 2011
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · Ulrich GmbH & Co. KG
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 266d
Cleared Feb 04, 2011
COHESION BONE CEMENT
K103816 · Teknimed Sas
NDN · Cement, Bone, Vertebroplasty · 37d
Cleared Feb 03, 2011
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
K103233 · Howmedica Osteonics Corp.
LZO · Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented · 93d
Cleared Feb 03, 2011
OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
K103309 · Smith & Nephew Endoscopy, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 85d
Cleared Feb 03, 2011
INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
K110045 · Vertebral Technologies, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 28d
Cleared Feb 02, 2011
SIGNATURE PLANNER
K102795 · Materialise NV
JWH · Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer · 128d
Cleared Feb 02, 2011
TALON SPINAL SYSTEM
K102995 · Spine360
MNI · Orthosis, Spinal Pedicle Fixation · 117d
Cleared Feb 02, 2011
POLARIS SPINAL SYSTEM
K103393 · Biomet Spine
KWQ · Appliance, Fixation, Spinal Intervertebral Body · 75d
Cleared Jan 31, 2011
PICCOLO COMPOSITE NAILING SYSTEM
K102369 · N.M.B. Medical Applications, Ltd.
HSB · Rod, Fixation, Intramedullary And Accessories · 164d
Cleared Jan 31, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K102924 · Tornier, Inc.
KWS · Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented · 123d
Cleared Jan 31, 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
K103208 · Encore Medical, L.P.
PHX · Shoulder Prosthesis, Reverse Configuration · 91d
Cleared Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
K103256 · Smith & Nephew, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 89d
Cleared Jan 28, 2011
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
K101263 · Lima-Lto S.P.A.
KWT · Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented · 268d
Cleared Jan 27, 2011
OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
K101459 · Smith & Nephew, Inc.
MAI · Fastener, Fixation, Biodegradable, Soft Tissue · 246d
Cleared Jan 27, 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · Synthes USA Products, LLC
MQV · Filler, Bone Void, Calcium Compound · 128d
Cleared Jan 27, 2011
REDONDO-L
K103297 · Seaspine, Inc.
MAX · Intervertebral Fusion Device With Bone Graft, Lumbar · 80d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886 · Medtronic Sofamor Danek, Inc.
KWP · Appliance, Fixation, Spinal Interlaminal · 118d

Looking for a specific orthopedic device? Search by device name, K-number or manufacturer.

Search all Orthopedic 510(k) devices

Filter by Product Code

All categories 17614 HRS Plate, Fixation, Bone 1320 HWC Screw, Fixation, Bone 1051 JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer 915 NKB Thoracolumbosacral Pedicle Screw System 914 MAX Intervertebral Fusion Device With Bone Graft, Lumbar 897 KWQ Appliance, Fixation, Spinal Intervertebral Body 664 HRX Arthroscope 632 MBI Fastener, Fixation, Nondegradable, Soft Tissue 604 LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented 560 JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented 545 LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented 532 HSB Rod, Fixation, Intramedullary And Accessories 517 MQV Filler, Bone Void, Calcium Compound 493 OLO Orthopedic Stereotaxic Instrument 439 KWP Appliance, Fixation, Spinal Interlaminal 418