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 Acufex Microsurgical, Inc., Depuy Mitek, A Johnson & Johnson Company and Arthrex, Inc..

231
Total
231
Cleared
133d
Avg days
1979
Since
231 devices
49–72 of 231
Cleared May 02, 2008
CAIS STAPLE
K073281
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 163d
Cleared Feb 13, 2008
ARTHREX COMPRESSION STAPLE
K080111
Arthrex, Inc.
Orthopedic · 28d
Cleared Oct 29, 2007
BIOPRO MEMORY STAPLE, MODELS 18062-18073
K072298
Biopro, Inc.
Orthopedic · 73d
Cleared Jun 29, 2007
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
K071257
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 56d
Cleared Aug 22, 2006
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 22d
Cleared Aug 21, 2006
BIOPRO MEMORY STAPLE
K061798
Biopro, Inc.
Orthopedic · 56d
Cleared May 25, 2006
MEMORY STAPLE
K060746
DePuy Orthopaedics, Inc.
Orthopedic · 66d
Cleared May 04, 2006
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE
K060553
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 64d
Cleared Oct 21, 2005
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052631
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 25d
Cleared Aug 05, 2005
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
K051989
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 14d
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 May 28, 2004
GII QUICKANCHOR PLUS
K041115
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 29d
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
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Jul 13, 1998
LACTOSORB POP RIVET
K981798
Biomet, Inc.
Orthopedic · 53d
Cleared Mar 13, 1997
HOWMEDICA MAINSTAY ANCHOR
K965175
Howmedica Corp.
Orthopedic · 79d
Cleared Jul 10, 1996
ACUFEX TAG BIOABSORBABLE ANCHORS
K961555
Acufex Microsurgical, Inc.
Orthopedic · 79d
Cleared Jul 10, 1996
SUTURE ANCHOR
K961578
United States Surgical, A Division of Tyco Healthc
Orthopedic · 77d
Cleared Jul 10, 1996
SURGICAL DYNAMICS POP RIVET
K961585
United States Surgical, A Division of Tyco Healthc
Orthopedic · 77d
Cleared Jan 18, 1996
PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
K950272
Ethicon, Inc.
Orthopedic · 360d
Cleared Oct 05, 1995
ACUFEX TAG DELIVERY SYSTEM
K953276
Acufex Microsurgical, Inc.
Orthopedic · 83d