HWC · Class II · 21 CFR 888.3040

FDA Product Code HWC: Screw, Fixation, Bone

FDA product code HWC covers bone fixation screws.

These implants are used to stabilize fractures, osteotomies, and bone grafts by compressing bone fragments together or anchoring plates and other fixation constructs. They are available in cortical, cancellous, and cannulated configurations for different anatomical sites and indications.

HWC devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Wrightmedicaltechnologyinc and Synthes (Usa).

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
817–840 of 1064
Cleared Oct 31, 1995
6.5MM SOLID CANCELLOUS BONE SCREW
K954485
Ace Medical Co.
Orthopedic · 34d
Cleared Sep 28, 1995
STRYKER ACL INTERFERENCE SCREW SYSTEM
K952460
Stryker Endoscopy
Orthopedic · 125d
Cleared Sep 15, 1995
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K952831
Linvatec Corp.
Orthopedic · 87d
Cleared Sep 12, 1995
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
K952697
Smith & Nephew Richards, Inc.
Orthopedic · 91d
Cleared Aug 18, 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296
Synthes (Usa)
Orthopedic · 94d
Cleared Jul 31, 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272
Synthes (Usa)
Orthopedic · 77d
Cleared Jul 24, 1995
REUNION BONE SCREW SYSTEM
K951389
Smith & Nephew Richards, Inc.
Orthopedic · 119d
Cleared Jul 11, 1995
ANSPACH SUTURE ANCHOR
K945525
The Anspach Effort, Inc.
Orthopedic · 243d
Cleared Jul 11, 1995
ABSORBABLE ACETABULAR SCREW
K946347
Zimmer, Inc.
Orthopedic · 193d
Cleared Jul 10, 1995
DEPUY SET SCREW
K950833
Depuy, Inc.
Orthopedic · 136d
Cleared Jul 05, 1995
ORTHOPEDIC SCREW FIXATION
K932350
Osteomed Corp.
Orthopedic · 782d
Cleared Jul 03, 1995
HARPOON SUTURE ANCHORS
K943806
Biomet, Inc.
Orthopedic · 333d
Cleared Jul 03, 1995
LMT BONE ANCHOR
K951233
Li Medical Technologies, Inc.
Orthopedic · 105d
Cleared Jul 03, 1995
LMT BONE ANCHOR
K951472
Li Medical Technologies, Inc.
Orthopedic · 95d
Cleared Jun 30, 1995
K4 BONE SCREW SYSTEM
K950704
Kinetikos Medical, Inc.
Orthopedic · 135d
Cleared Jun 22, 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652
Osteotech, Inc.
Orthopedic · 129d
Cleared Jun 16, 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304
Synthes (Usa)
Orthopedic · 86d
Cleared Jun 14, 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590
Smith & Nephew Richards, Inc.
Orthopedic · 628d
Cleared May 10, 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321
Linvatec Corp.
Orthopedic · 614d
Cleared May 05, 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330
Acu Med, Inc.
Orthopedic · 241d
Cleared Apr 14, 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426
Arthrex, Inc.
Orthopedic · 161d
Cleared Feb 02, 1995
BONE MULCH SCREW
K941941
Biomet, Inc.
Orthopedic · 287d
Cleared Jan 24, 1995
DYONICS FIXATION SCREWS
K945182
Smith & Nephew Dyonics, Inc.
Orthopedic · 92d
Cleared Dec 09, 1994
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213
Howmedica Corp.
Orthopedic · 102d