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
73–96 of 231
Cleared Sep 26, 1995
HOWMEDICA MAINSTAY ANCHOR
K953531
Howmedica Corp.
Orthopedic · 61d
Cleared May 30, 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950
Ethicon, Inc.
Orthopedic · 288d
Cleared Apr 26, 1995
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346
Acufex Microsurgical, Inc.
Orthopedic · 117d
Cleared Mar 20, 1995
BIOABSORBABLE INTERFERENCE SCREW
K943548
Acufex Microsurgical, Inc.
Orthopedic · 242d
Cleared Feb 09, 1995
ACUFEX TAG ANCHOR
K934867
Acufex Microsurgical, Inc.
Orthopedic · 485d
Cleared Feb 01, 1995
ARTHREX STAPLES
K943492
Arthrex, Inc.
Orthopedic · 197d
Cleared Dec 15, 1994
BONE ANCHOR
K942787
Acu Med, Inc.
Orthopedic · 185d
Cleared Jun 16, 1994
ACUFEX SURETAC
K931519
Acufex Microsurgical, Inc.
Orthopedic · 447d
Cleared Nov 16, 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384
Zimmer, Inc.
Orthopedic · 329d
Cleared Sep 13, 1993
ACUFEX SURETAC(R) PAC
K930538
Acufex Microsurgical, Inc.
Orthopedic · 223d
Cleared Jul 21, 1993
ACUFEX(R) TAG(TM)
K911293
Acufex Microsurgical, Inc.
Orthopedic · 849d
Cleared Jun 04, 1993
CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
K924941
Linvatec Corp.
Orthopedic · 247d
Cleared May 05, 1993
HARPOON SUTURE ANCHOR
K926037
Biomet, Inc.
Orthopedic · 155d
Cleared Nov 15, 1991
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
K911837
Acufex Microsurgical, Inc.
Orthopedic · 204d
Cleared Dec 21, 1990
BONE STAPLE(S)
K904553
Synthes (Usa)
Orthopedic · 77d
Cleared Aug 09, 1990
FIXATION STAPLE
K903022
Onyx Medical Corp.
Orthopedic · 30d
Cleared Jul 30, 1990
ROUND STAPLE
K903271
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
BARBED SQUARE STAPLE
K903273
Onyx Medical Corp.
Orthopedic · 6d
Cleared May 09, 1990
HTO COMPRESSING STAPLE
K895117
Howmedica Corp.
Orthopedic · 267d
Cleared Aug 30, 1989
STAPLE FIXATION SYSTEM
K894929
Concept, Inc.
Orthopedic · 28d
Cleared Feb 04, 1988
ORTHOMET ORTHOPEDIC STAPLES
K874914
Orthomet, Inc.
Orthopedic · 63d
Cleared Nov 19, 1985
KIRSCHNER BONE FIXATION FASTENER SYSTEM
K854445
Kirschner Medical Corp.
Orthopedic · 14d
Cleared Nov 23, 1984
BONE STAPLING FIXATION SYS
K840566
3M Company
Orthopedic · 289d
Cleared Oct 27, 1982
ELLISON VITALLIUM FIXATION STAPLE SYS
K822943
Howmedica Corp.
Orthopedic · 23d