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., Wrightmedicaltechnologyinc and Synthes (Usa).

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
313–336 of 1064
Cleared Nov 20, 2014
PhaLinx Hammertoe System
K142585
Wrightmedicaltechnologyinc
Orthopedic · 66d
Cleared Nov 18, 2014
J-SCREW COMPRESSION SCREW
K130019
Competitive Engineering, Inc.
Orthopedic · 684d
Cleared Nov 13, 2014
Biomet Headless Compression and Twist-off Screws
K142658
Biomet Manufacturing Corp
Orthopedic · 56d
Cleared Oct 03, 2014
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM
K142442
Zimmer, Inc.
Orthopedic · 31d
Cleared Oct 03, 2014
HyProCure II
K142534
Graham Medical Technologies, LLC Dba Gramedica
Orthopedic · 24d
Cleared Sep 29, 2014
HELICAL RIDGE PEEK INTERFERENCE SCREW
K141290
MedShape, Inc.
Orthopedic · 133d
Cleared Sep 12, 2014
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
K141949
Aap Implantate AG
Orthopedic · 56d
Cleared Sep 10, 2014
TRIDENT FUSION IMPLANT
K141937
Vilex IN Tennessee, Inc.
Orthopedic · 55d
Cleared Jul 30, 2014
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
K132912
In2bones Sas
Orthopedic · 316d
Cleared Jul 03, 2014
NORMED VARIO SUBTALAR SCREW
K140962
Normed Nedizin Technik GmbH
Orthopedic · 79d
Cleared Jun 03, 2014
BIOMET CANNULATED SCREW SYSTEM
K140891
Biomet, Inc.
Orthopedic · 56d
Cleared May 15, 2014
SMITH & NEPHEW CANNULATED CAPTURED SCREW
K133662
Smith & Nephew, Inc.
Orthopedic · 167d
Cleared May 15, 2014
SALVATION BEAMS AND BOLTS SYSTEM
K140741
Wrightmedicaltechnologyinc
Orthopedic · 51d
Cleared May 15, 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952
Wrightmedicaltechnologyinc
Orthopedic · 31d
Cleared May 14, 2014
SALVATION OSTEOPENIC SCREW
K140408
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared May 13, 2014
ONE-PIECE PEEK FUSION IMPLANT
K140970
Mtp Solutions, LLC
Orthopedic · 27d
Cleared May 01, 2014
STABILIZATION SCREW
K131920
In2bones Sas
Orthopedic · 309d
Cleared Apr 04, 2014
I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
K132911
In2bones Sas
Orthopedic · 199d
Cleared Mar 28, 2014
PEEK FUSION IMPLANT
K133515
Mtp Solutions, LLC
Orthopedic · 133d
Cleared Mar 28, 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636
Extremity Medical, LLC
Orthopedic · 122d
Cleared Mar 20, 2014
TYBER MEDICAL TRAUMA SCREW
K133842
Tyber Medical, LLC
Orthopedic · 92d
Cleared Mar 07, 2014
CHARLOTTE (TM) SNAP-OFF SCREW
K133713
Wrightmedicaltechnologyinc
Orthopedic · 92d
Cleared Mar 07, 2014
PRO-TOE HAMMERTOE FIXATION SYSTEM
K140148
Wrightmedicaltechnologyinc
Orthopedic · 44d
Cleared Mar 06, 2014
N-FORCE FIXATION SYSTEM
K132244
Innovision, Inc.
Orthopedic · 231d