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
Sep 26, 1995
HOWMEDICA MAINSTAY ANCHOR
Howmedica Corp.
Orthopedic
61d
Cleared
May 30, 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
Ethicon, Inc.
Orthopedic
288d
Cleared
Apr 26, 1995
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
Acufex Microsurgical, Inc.
Orthopedic
117d
Cleared
Mar 20, 1995
BIOABSORBABLE INTERFERENCE SCREW
Acufex Microsurgical, Inc.
Orthopedic
242d
Cleared
Feb 09, 1995
ACUFEX TAG ANCHOR
Acufex Microsurgical, Inc.
Orthopedic
485d
Cleared
Feb 01, 1995
ARTHREX STAPLES
Arthrex, Inc.
Orthopedic
197d
Cleared
Dec 15, 1994
BONE ANCHOR
Acu Med, Inc.
Orthopedic
185d
Cleared
Jun 16, 1994
ACUFEX SURETAC
Acufex Microsurgical, Inc.
Orthopedic
447d
Cleared
Nov 16, 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
Zimmer, Inc.
Orthopedic
329d
Cleared
Sep 13, 1993
ACUFEX SURETAC(R) PAC
Acufex Microsurgical, Inc.
Orthopedic
223d
Cleared
Jul 21, 1993
ACUFEX(R) TAG(TM)
Acufex Microsurgical, Inc.
Orthopedic
849d
Cleared
Jun 04, 1993
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
Linvatec Corp.
Orthopedic
247d
Cleared
May 05, 1993
HARPOON SUTURE ANCHOR
Biomet, Inc.
Orthopedic
155d
Cleared
Nov 15, 1991
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
Acufex Microsurgical, Inc.
Orthopedic
204d
Cleared
Dec 21, 1990
BONE STAPLE(S)
Synthes (Usa)
Orthopedic
77d
Cleared
Aug 09, 1990
FIXATION STAPLE
Onyx Medical Corp.
Orthopedic
30d
Cleared
Jul 30, 1990
ROUND STAPLE
Onyx Medical Corp.
Orthopedic
6d
Cleared
Jul 30, 1990
BARBED SQUARE STAPLE
Onyx Medical Corp.
Orthopedic
6d
Cleared
May 09, 1990
HTO COMPRESSING STAPLE
Howmedica Corp.
Orthopedic
267d
Cleared
Aug 30, 1989
STAPLE FIXATION SYSTEM
Concept, Inc.
Orthopedic
28d
Cleared
Feb 04, 1988
ORTHOMET ORTHOPEDIC STAPLES
Orthomet, Inc.
Orthopedic
63d
Cleared
Nov 19, 1985
KIRSCHNER BONE FIXATION FASTENER SYSTEM
Kirschner Medical Corp.
Orthopedic
14d
Cleared
Nov 23, 1984
BONE STAPLING FIXATION SYS
3M Company
Orthopedic
289d
Cleared
Oct 27, 1982
ELLISON VITALLIUM FIXATION STAPLE SYS
Howmedica Corp.
Orthopedic
23d