FDA Product Code JDR: Staple, Fixation, Bone
Staple fixation provides a low-profile alternative to screws in certain fracture patterns. FDA product code JDR covers bone fixation staples.
These U-shaped implants are driven across fracture lines or osteotomy sites to compress and stabilize bone segments. They are particularly used in foot and ankle surgery, small joint fusions, and procedures where a low-profile implant is preferred.
JDR devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Acufex Microsurgical, Inc., Depuy Mitek, A Johnson & Johnson Company and Arthrex, Inc..
231
Total
231
Cleared
133d
Avg days
1979
Since
231 devices
Cleared
Dec 16, 2020
Arthrex DynaNite Nitinol Staples
Arthrex, Inc.
Orthopedic
51d
Cleared
Apr 23, 2020
DynaClip Bone Staple
MedShape, Inc.
Orthopedic
146d
Cleared
Feb 28, 2020
Superelastic Staple
Neosteo
Orthopedic
175d
Cleared
Feb 26, 2020
DePuy Synthes Hammertoe Continuous Compression Implant
Synthes USA Products, LLC
Orthopedic
268d
Cleared
Aug 16, 2019
TriMAX Implant System
Crossroads Extemity Systems, LLC
Orthopedic
149d
Cleared
Aug 16, 2019
APTUS Foot System
Medartis AG
Orthopedic
58d
Cleared
Jul 01, 2019
TriMed Nitinol Staple System
TriMed, Inc.
Orthopedic
151d
Cleared
Apr 04, 2019
VERTEX Nitinol Staple System
Nvision Biomedical Technologies, LLC
Orthopedic
163d
Cleared
Jan 11, 2019
Geo Staple System
Gramercy Extremity Orthopedics, LLC
Orthopedic
149d
Cleared
Nov 05, 2018
DynaClipTM Bone Staple
MedShape, Inc.
Orthopedic
125d
Cleared
Oct 15, 2018
DynaBridge
Fusion Orthopedics, LLC
Orthopedic
98d
Cleared
Aug 09, 2018
MotoCLIP/HiMAX Step Staple Implant System
Crossroads Extremity Systems, LLC
Orthopedic
28d
Cleared
Jul 24, 2018
DePuy Synthes Static Staples
Synthes USA Products, LLC
Orthopedic
145d
Cleared
Jun 29, 2018
MotoCLIP/HiMAX Implant System
Crossroads Extremity Systems, LLC
Orthopedic
30d
Cleared
Apr 06, 2018
Clench Compression Staple
F & A Foundation, LLC D.B.A. Reign Medical
Orthopedic
115d
Cleared
Feb 23, 2018
Orbitum Bone Staple Implant, X and VI
Orthovestments, LLC
Orthopedic
84d
Cleared
Jan 11, 2018
ExoToe Staple
Exotoe, LLC
Orthopedic
174d
Cleared
Dec 13, 2017
Arthrex DynaNite Nitinol Staple
Arthrex, Inc.
Orthopedic
160d
Cleared
Jul 26, 2016
EasyStep
Stryker GmbH
Orthopedic
124d
Cleared
Oct 02, 2015
TiTHON Staple with OsseoTi Technology
Biomet Manufacturing Corp
Orthopedic
109d
Cleared
Jan 20, 2015
SnapShot Fixation System
Biomet Manufacturing Corp
Orthopedic
90d
Cleared
Nov 19, 2014
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
Biomet Manufacturing Corp
Orthopedic
188d
Cleared
Mar 12, 2013
MEMORY METAL STAPLES, EASYCLIP
Stryker Corp.
Orthopedic
238d
Cleared
Jul 17, 2008
COMPOSITE HITCH SUTURE ANCHOR
Biomet Manufacturing Corp
Orthopedic
84d