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., Synthes (Usa) and Wrightmedicaltechnologyinc.

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
289–312 of 1059
Cleared Aug 19, 2004
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
K040542
Smith & Nephew, Inc.
Orthopedic · 170d
Cleared Jun 15, 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701
Synthes (Usa)
Orthopedic · 90d
Cleared May 25, 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared May 21, 2004
MICROMAX SUTURE ANCHOR
K040475
Biomet, Inc.
Orthopedic · 87d
Cleared Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331
Smith & Nephew, Inc.
Orthopedic · 63d
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594
United States Surgical, A Division of Tyco Healthc
Orthopedic · 23d
Cleared Mar 01, 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975
Synthes (Usa)
Orthopedic · 69d
Cleared Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233
Biomet, Inc.
Orthopedic · 30d
Cleared Oct 07, 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
K032098
Arthrex, Inc.
Orthopedic · 91d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945
Arthrex, Inc.
Orthopedic · 90d
Cleared Aug 08, 2003
BIORCI SCREW
K032224
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Jul 01, 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 44d
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 02, 2002
MODULAR HEAD BONE SCREW
K022952
Biomet, Inc.
Orthopedic · 88d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234
Arthrex, Inc.
Orthopedic · 84d
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932
Synthes (Usa)
Orthopedic · 86d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556
Synthes (Usa)
Orthopedic · 88d
Cleared Jul 01, 2002
SMALL HAMMER TOE PIN
K021828
Biomet, Inc.
Orthopedic · 27d
Cleared Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832
Biomet, Inc.
Orthopedic · 22d
Cleared Apr 02, 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043
Arthrex, Inc.
Orthopedic · 85d
Cleared Mar 26, 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159
Smith & Nephew, Inc.
Orthopedic · 68d