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., Wrightmedicaltechnologyinc and Synthes (Usa).
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Jan 13, 2015
Headless Compression Screw System
Skeletal Dynamics, LLC
Orthopedic
22d
Cleared
Jan 08, 2015
CrossTie Intraosseous Fixation System
Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem
Orthopedic
182d
Cleared
Dec 30, 2014
3.Omm Biomet Cannulated Screw System
Biomet Manufacturing Corp
Orthopedic
55d
Cleared
Dec 22, 2014
AnthroBridge-Screw 25,30,35,40,45,50mm
Agent Medical, LLC
Orthopedic
104d
Cleared
Dec 19, 2014
AIS Odontoid Fracture Fixation System
Aesculap Implant System, Inc.
Orthopedic
88d
Cleared
Dec 15, 2014
ProxiFuse Hammer Toe Device
Cartiva, Inc.
Orthopedic
102d
Cleared
Nov 20, 2014
PhaLinx Hammertoe System
Wrightmedicaltechnologyinc
Orthopedic
66d
Cleared
Nov 18, 2014
J-SCREW COMPRESSION SCREW
Competitive Engineering, Inc.
Orthopedic
684d
Cleared
Nov 13, 2014
Biomet Headless Compression and Twist-off Screws
Biomet Manufacturing Corp
Orthopedic
56d
Cleared
Oct 03, 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
31d
Cleared
Oct 03, 2014
HyProCure II
Graham Medical Technologies, LLC Dba Gramedica
Orthopedic
24d
Cleared
Sep 29, 2014
HELICAL RIDGE PEEK INTERFERENCE SCREW
MedShape, Inc.
Orthopedic
133d
Cleared
Sep 12, 2014
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
Aap Implantate AG
Orthopedic
56d
Cleared
Sep 10, 2014
TRIDENT FUSION IMPLANT
Vilex IN Tennessee, Inc.
Orthopedic
55d
Cleared
Jul 30, 2014
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
In2bones Sas
Orthopedic
316d
Cleared
Jul 03, 2014
NORMED VARIO SUBTALAR SCREW
Normed Nedizin Technik GmbH
Orthopedic
79d
Cleared
Jun 03, 2014
BIOMET CANNULATED SCREW SYSTEM
Biomet, Inc.
Orthopedic
56d
Cleared
May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
Smith & Nephew, Inc.
Orthopedic
167d
Cleared
May 15, 2014
SALVATION BEAMS AND BOLTS SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
51d
Cleared
May 15, 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
Wrightmedicaltechnologyinc
Orthopedic
31d
Cleared
May 14, 2014
SALVATION OSTEOPENIC SCREW
Wrightmedicaltechnologyinc
Orthopedic
85d
Cleared
May 13, 2014
ONE-PIECE PEEK FUSION IMPLANT
Mtp Solutions, LLC
Orthopedic
27d
Cleared
May 01, 2014
STABILIZATION SCREW
In2bones Sas
Orthopedic
309d
Cleared
Apr 04, 2014
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
In2bones Sas
Orthopedic
199d