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
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
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
Sep 26, 1995
HOWMEDICA MAINSTAY ANCHOR
Howmedica Corp.
Orthopedic
61d
Cleared
Feb 01, 1995
ARTHREX STAPLES
Arthrex, Inc.
Orthopedic
197d
Cleared
Nov 16, 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
Zimmer, Inc.
Orthopedic
329d
Cleared
May 05, 1993
HARPOON SUTURE ANCHOR
Biomet, Inc.
Orthopedic
155d
Cleared
Dec 21, 1990
BONE STAPLE(S)
Synthes (Usa)
Orthopedic
77d
Cleared
May 09, 1990
HTO COMPRESSING STAPLE
Howmedica Corp.
Orthopedic
267d
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
Cleared
Dec 05, 1979
HOWMEDICA COMPRESSION STAPLE SYSTEM
Howmedica Corp.
Orthopedic
33d