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
17719 Orthopedic devices
Cleared
May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
MBI
Fastener, Fixation, Nondegradable, Soft Tissue
87d
Cleared
May 11, 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
KRO
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
179d
Cleared
May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
HWC
Screw, Fixation, Bone
68d
Cleared
May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
KWQ
Appliance, Fixation, Spinal Intervertebral Body
239d
Cleared
May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
MQP
Spinal Vertebral Body Replacement Device
221d
Cleared
May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
MNI
Orthosis, Spinal Pedicle Fixation
155d
Cleared
May 08, 2001
CLARIS PLATE SYSTEM
MNH
Orthosis, Spondylolisthesis Spinal Fixation
90d
Cleared
May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
HTY
Pin, Fixation, Smooth
77d
Cleared
May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
HWC
Screw, Fixation, Bone
69d
Cleared
May 07, 2001
XPS 3000 SYSTEM
HRX
Arthroscope
61d
Cleared
May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
MNI
Orthosis, Spinal Pedicle Fixation
25d
Cleared
May 04, 2001
APEX FIXATION PINS
JDW
Pin, Fixation, Threaded
21d
Cleared
May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
KTT
Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
87d
Cleared
May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
KTW
Appliance, Fixation, Nail/blade/plate Combination, Single Component
89d
Cleared
May 02, 2001
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
HSB
Rod, Fixation, Intramedullary And Accessories
89d
Cleared
Apr 27, 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
HRX
Arthroscope
144d
Cleared
Apr 27, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
JDI
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
63d
Cleared
Apr 26, 2001
SMARTSCREW MODEL 222006...227510
HWC
Screw, Fixation, Bone
205d
Cleared
Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
LPH
Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
14d
Cleared
Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
MQP
Spinal Vertebral Body Replacement Device
186d
Cleared
Apr 20, 2001
SYNPLUG
LZN
Cement Obturator
30d
Cleared
Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
LPH
Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
90d
Cleared
Apr 18, 2001
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
HRY
Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
30d
Cleared
Apr 18, 2001
CLS VARUS STEM/CLS 135 STEM
LZO
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
28d
Cleared
Apr 18, 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
MNH
Orthosis, Spondylolisthesis Spinal Fixation
28d
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