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
241–264 of 1059
Cleared Jul 31, 2009
SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
K090949
Synthes (Usa)
Orthopedic · 119d
Cleared Jun 03, 2009
INTERTAN CHS LIMITED COLLAPSE SET SCREW
K090656
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Nov 05, 2008
DARCO SMALL SCREW
K082320
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Jul 17, 2008
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700
Synthes (Usa)
Orthopedic · 30d
Cleared May 01, 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071
Synthes (Usa)
Orthopedic · 16d
Cleared Apr 23, 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943
Synthes (Usa)
Orthopedic · 20d
Cleared Apr 10, 2008
DARCO HEADLESS COMPRESSION SCREW
K080850
Wrightmedicaltechnologyinc
Orthopedic · 15d
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509
Smith & Nephew, Inc.
Orthopedic · 82d
Cleared Sep 12, 2007
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
K071437
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 112d
Cleared Jun 29, 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
K071177
Arthrex, Inc.
Orthopedic · 63d
Cleared May 11, 2007
ASNIS MICRO CANNULATED SCREW
K071092
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared May 01, 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
K070906
Zimmer, Inc.
Orthopedic · 29d
Cleared Mar 29, 2007
CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
K070525
Wrightmedicaltechnologyinc
Orthopedic · 34d
Cleared Dec 13, 2006
ARTHREX PUSHLOCK
K063479
Arthrex, Inc.
Orthopedic · 26d
Cleared Oct 19, 2006
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
K061863
Arthrex, Inc.
Orthopedic · 111d
Cleared Oct 19, 2006
FRS SCREW
K062352
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Sep 27, 2006
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
K062679
Arthrex, Inc.
Orthopedic · 19d
Cleared Jul 27, 2006
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
K061621
Synthes (Usa)
Orthopedic · 45d
Cleared Jul 25, 2006
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
K061665
Arthrex, Inc.
Orthopedic · 41d
Cleared May 19, 2006
ARTHREX BIO-COMPRESSION SCREW
K060478
Arthrex, Inc.
Orthopedic · 85d
Cleared Apr 26, 2006
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
K060710
Zimmer, Inc.
Orthopedic · 41d
Cleared Apr 18, 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Apr 03, 2006
ARTHREX ARTHOERESIS IMPLANT
K053543
Arthrex, Inc.
Orthopedic · 104d