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
Feb 23, 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
Smith & Nephew, Inc.
Orthopedic
83d
Cleared
Jan 26, 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
Arthrex, Inc.
Orthopedic
56d
Cleared
Jan 05, 2006
5TH METATARSAL FRACTURE SCREW
Wrightmedicaltechnologyinc
Orthopedic
57d
Cleared
Nov 07, 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
Arthrex, Inc.
Orthopedic
46d
Cleared
Sep 27, 2005
ARTHREX TENODESIS FAMILY
Arthrex, Inc.
Orthopedic
91d
Cleared
Jul 26, 2005
PLC SCREW
Smith & Nephew, Inc.
Orthopedic
68d
Cleared
Jul 07, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
Zimmer, Inc.
Orthopedic
69d
Cleared
May 12, 2005
ARTHREX TAK FAMILY
Arthrex, Inc.
Orthopedic
50d
Cleared
Apr 27, 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
Synthes (Usa)
Orthopedic
41d
Cleared
Apr 21, 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
Synthes (Usa)
Orthopedic
41d
Cleared
Apr 15, 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
Arthrex, Inc.
Orthopedic
60d
Cleared
Apr 11, 2005
CHARLOTTE SNAP-OFF SCREW
Wrightmedicaltechnologyinc
Orthopedic
11d
Cleared
Mar 21, 2005
MODIFICATION TO: ARTHREX V-TAK
Arthrex, Inc.
Orthopedic
12d
Cleared
Feb 11, 2005
ASIAN INTRAMEDULLARY HIP SCREW NAILS
Smith & Nephew, Inc.
Orthopedic
10d
Cleared
Feb 03, 2005
SYNTHES 3.5MM CORTEX SCREWS
Synthes (Usa)
Orthopedic
78d
Cleared
Jan 26, 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
Wrightmedicaltechnologyinc
Orthopedic
29d
Cleared
Jan 21, 2005
MULTI-USE COMPRESSION SCREW
Wrightmedicaltechnologyinc
Orthopedic
73d
Cleared
Jan 19, 2005
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
Wrightmedicaltechnologyinc
Orthopedic
54d
Cleared
Dec 14, 2004
BIO-CORE INTERFERENCE SCREW
Biomet, Inc.
Orthopedic
85d
Cleared
Dec 14, 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
Arthrex, Inc.
Orthopedic
11d
Cleared
Nov 04, 2004
ARTHREX TRIMIT FAMILY
Arthrex, Inc.
Orthopedic
182d
Cleared
Nov 04, 2004
ARTHREX TENODESIS SCREW FAMILY
Arthrex, Inc.
Orthopedic
168d
Cleared
Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
Synthes (Usa)
Orthopedic
37d
Cleared
Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
Synthes (Usa)
Orthopedic
85d