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
265–288 of 1059
Cleared Feb 23, 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
K053344
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Jan 26, 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338
Arthrex, Inc.
Orthopedic · 56d
Cleared Jan 05, 2006
5TH METATARSAL FRACTURE SCREW
K053136
Wrightmedicaltechnologyinc
Orthopedic · 57d
Cleared Nov 07, 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
K052607
Arthrex, Inc.
Orthopedic · 46d
Cleared Sep 27, 2005
ARTHREX TENODESIS FAMILY
K051726
Arthrex, Inc.
Orthopedic · 91d
Cleared Jul 26, 2005
PLC SCREW
K051310
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 07, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098
Zimmer, Inc.
Orthopedic · 69d
Cleared May 12, 2005
ARTHREX TAK FAMILY
K050749
Arthrex, Inc.
Orthopedic · 50d
Cleared Apr 27, 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 21, 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 15, 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
K050358
Arthrex, Inc.
Orthopedic · 60d
Cleared Apr 11, 2005
CHARLOTTE SNAP-OFF SCREW
K050819
Wrightmedicaltechnologyinc
Orthopedic · 11d
Cleared Mar 21, 2005
MODIFICATION TO: ARTHREX V-TAK
K050634
Arthrex, Inc.
Orthopedic · 12d
Cleared Feb 11, 2005
ASIAN INTRAMEDULLARY HIP SCREW NAILS
K050226
Smith & Nephew, Inc.
Orthopedic · 10d
Cleared Feb 03, 2005
SYNTHES 3.5MM CORTEX SCREWS
K043185
Synthes (Usa)
Orthopedic · 78d
Cleared Jan 26, 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Jan 21, 2005
MULTI-USE COMPRESSION SCREW
K043102
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Jan 19, 2005
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
K043281
Wrightmedicaltechnologyinc
Orthopedic · 54d
Cleared Dec 14, 2004
BIO-CORE INTERFERENCE SCREW
K042552
Biomet, Inc.
Orthopedic · 85d
Cleared Dec 14, 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
K043337
Arthrex, Inc.
Orthopedic · 11d
Cleared Nov 04, 2004
ARTHREX TRIMIT FAMILY
K041189
Arthrex, Inc.
Orthopedic · 182d
Cleared Nov 04, 2004
ARTHREX TENODESIS SCREW FAMILY
K041356
Arthrex, Inc.
Orthopedic · 168d
Cleared Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356
Synthes (Usa)
Orthopedic · 37d
Cleared Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
K041533
Synthes (Usa)
Orthopedic · 85d