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