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).
1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
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
Cleared
Mar 28, 2014
PEEK FUSION IMPLANT
Mtp Solutions, LLC
Orthopedic
133d
Cleared
Mar 28, 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
Extremity Medical, LLC
Orthopedic
122d
Cleared
Mar 20, 2014
TYBER MEDICAL TRAUMA SCREW
Tyber Medical, LLC
Orthopedic
92d
Cleared
Mar 07, 2014
CHARLOTTE (TM) SNAP-OFF SCREW
Wrightmedicaltechnologyinc
Orthopedic
92d
Cleared
Mar 07, 2014
PRO-TOE HAMMERTOE FIXATION SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
44d
Cleared
Mar 06, 2014
N-FORCE FIXATION SYSTEM
Innovision, Inc.
Orthopedic
231d