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
May 02, 2008
CAIS STAPLE
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
163d
Cleared
Feb 13, 2008
ARTHREX COMPRESSION STAPLE
Arthrex, Inc.
Orthopedic
28d
Cleared
Oct 29, 2007
BIOPRO MEMORY STAPLE, MODELS 18062-18073
Biopro, Inc.
Orthopedic
73d
Cleared
Jun 29, 2007
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
56d
Cleared
Aug 22, 2006
BIOKNOTLESS AND LUPINE PLUS ANCHORS
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
22d
Cleared
Aug 21, 2006
BIOPRO MEMORY STAPLE
Biopro, Inc.
Orthopedic
56d
Cleared
May 25, 2006
MEMORY STAPLE
DePuy Orthopaedics, Inc.
Orthopedic
66d
Cleared
May 04, 2006
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
64d
Cleared
Oct 21, 2005
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
25d
Cleared
Aug 05, 2005
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
14d
Cleared
Jan 18, 2005
COMPRESSION STAPLE AND SIMPLE STAPLE
Wrightmedicaltechnologyinc
Orthopedic
74d
Cleared
Oct 20, 2004
ARTHROTEK MENISCAL HYBRID DEVICE
Biomet, Inc.
Orthopedic
89d
Cleared
May 28, 2004
GII QUICKANCHOR PLUS
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
29d
Cleared
Apr 28, 2003
ORTHOPEDIC WIRE
Howmedica Osteonics Corp.
Orthopedic
19d
Cleared
Nov 07, 2002
SURETAC III, MODELS 7209900, 7209901
Smith & Nephew, Inc.
Orthopedic
27d
Cleared
Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
Smith & Nephew, Inc.
Orthopedic
198d
Cleared
Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
Medtronic Sofamor Danek, Inc.
Orthopedic
90d
Cleared
Jul 13, 1998
LACTOSORB POP RIVET
Biomet, Inc.
Orthopedic
53d
Cleared
Mar 13, 1997
HOWMEDICA MAINSTAY ANCHOR
Howmedica Corp.
Orthopedic
79d
Cleared
Jul 10, 1996
ACUFEX TAG BIOABSORBABLE ANCHORS
Acufex Microsurgical, Inc.
Orthopedic
79d
Cleared
Jul 10, 1996
SUTURE ANCHOR
United States Surgical, A Division of Tyco Healthc
Orthopedic
77d
Cleared
Jul 10, 1996
SURGICAL DYNAMICS POP RIVET
United States Surgical, A Division of Tyco Healthc
Orthopedic
77d
Cleared
Jan 18, 1996
PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
Ethicon, Inc.
Orthopedic
360d
Cleared
Oct 05, 1995
ACUFEX TAG DELIVERY SYSTEM
Acufex Microsurgical, Inc.
Orthopedic
83d