JDR · Class II · 21 CFR 888.3030

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 Howmedica Corp., Arthrex, Inc. and Treace Medical Concepts.

231
Total
231
Cleared
133d
Avg days
1979
Since
231 devices
25–48 of 231
Cleared Dec 16, 2020
Arthrex DynaNite Nitinol Staples
K203180
Arthrex, Inc.
Orthopedic · 51d
Cleared Apr 23, 2020
DynaClip Bone Staple
K193305
MedShape, Inc.
Orthopedic · 146d
Cleared Feb 28, 2020
Superelastic Staple
K192447
Neosteo
Orthopedic · 175d
Cleared Feb 26, 2020
DePuy Synthes Hammertoe Continuous Compression Implant
K191463
Synthes USA Products, LLC
Orthopedic · 268d
Cleared Aug 16, 2019
TriMAX Implant System
K190722
Crossroads Extemity Systems, LLC
Orthopedic · 149d
Cleared Aug 16, 2019
APTUS Foot System
K191636
Medartis AG
Orthopedic · 58d
Cleared Jul 01, 2019
TriMed Nitinol Staple System
K190166
TriMed, Inc.
Orthopedic · 151d
Cleared Apr 04, 2019
VERTEX Nitinol Staple System
K182943
Nvision Biomedical Technologies, LLC
Orthopedic · 163d
Cleared Jan 11, 2019
Geo Staple System
K182212
Gramercy Extremity Orthopedics, LLC
Orthopedic · 149d
Cleared Nov 05, 2018
DynaClipTM Bone Staple
K181781
MedShape, Inc.
Orthopedic · 125d
Cleared Oct 15, 2018
DynaBridge
K181815
Fusion Orthopedics, LLC
Orthopedic · 98d
Cleared Aug 09, 2018
MotoCLIP/HiMAX Step Staple Implant System
K181866
Crossroads Extremity Systems, LLC
Orthopedic · 28d
Cleared Jul 24, 2018
DePuy Synthes Static Staples
K180544
Synthes USA Products, LLC
Orthopedic · 145d
Cleared Jun 29, 2018
MotoCLIP/HiMAX Implant System
K181410
Crossroads Extremity Systems, LLC
Orthopedic · 30d
Cleared Apr 06, 2018
Clench Compression Staple
K173775
F & A Foundation, LLC D.B.A. Reign Medical
Orthopedic · 115d
Cleared Feb 23, 2018
Orbitum Bone Staple Implant, X and VI
K173693
Orthovestments, LLC
Orthopedic · 84d
Cleared Jan 11, 2018
ExoToe Staple
K172205
Exotoe, LLC
Orthopedic · 174d
Cleared Dec 13, 2017
Arthrex DynaNite Nitinol Staple
K172052
Arthrex, Inc.
Orthopedic · 160d
Cleared Feb 13, 2008
ARTHREX COMPRESSION STAPLE
K080111
Arthrex, Inc.
Orthopedic · 28d
Cleared Jan 18, 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059
Wrightmedicaltechnologyinc
Orthopedic · 74d
Cleared Oct 20, 2004
ARTHROTEK MENISCAL HYBRID DEVICE
K041988
Biomet, Inc.
Orthopedic · 89d
Cleared Apr 28, 2003
ORTHOPEDIC WIRE
K031127
Howmedica Osteonics Corp.
Orthopedic · 19d
Cleared Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
K023417
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948
Smith & Nephew, Inc.
Orthopedic · 198d