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.

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
361–384 of 1064
Cleared Apr 05, 2013
MERETEC CS, CORTICAL SCREWS
K130400
Merete Medical GmbH
Orthopedic · 45d
Cleared Mar 18, 2013
ACUMED CANNULATED SCREW SYSTEM
K123890
Acumed, LLC
Orthopedic · 90d
Cleared Feb 27, 2013
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
K123672
Inion OY
Orthopedic · 90d
Cleared Feb 01, 2013
MILAGRO ADVANCE INTERFERENCE SCREW
K123362
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 92d
Cleared Dec 10, 2012
EMERGE MEDICAL SOLID BONE SCREWS
K122489
Emerge Medical
Orthopedic · 117d
Cleared Nov 20, 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Nov 07, 2012
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
K121277
Z-Medical GmbH & Co. KG
Orthopedic · 194d
Cleared Nov 07, 2012
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K122738
Solana Surgical, LLC
Orthopedic · 62d
Cleared Nov 07, 2012
HAMMER TOE IMPLANT
K122959
Trilliant Surgical, Ltd.
Orthopedic · 43d
Cleared Oct 09, 2012
NEXTRA TI HAMMERTOE CORRECTION SYSTEM
K122031
Nextremity Solutions, LLC
Orthopedic · 90d
Cleared Oct 04, 2012
ACTIVE SCREW BONE SCREW
K121682
Intelligent Implant Systems, LLC
Orthopedic · 119d
Cleared Sep 27, 2012
PMT BONE SCREWS
K121713
Providence Medical Technology, Inc.
Orthopedic · 108d
Cleared Aug 20, 2012
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
K121148
Medical Design, LLC
Orthopedic · 126d
Cleared Jul 18, 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349
Extremity Medical, LLC
Orthopedic · 75d
Cleared Jul 18, 2012
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
K121417
Extremity Medical, LLC
Orthopedic · 68d
Cleared Jun 05, 2012
CITIEFFE-TITANIUM CANNULATED SCREW
K113388
Citieffe
Orthopedic · 202d
Cleared May 25, 2012
I-FUSE HAMMER TOE SYSTEMS
K113006
Orthopro, LLC
Orthopedic · 231d
Cleared May 17, 2012
MINI CANNULATED HEADED AND HEADLESS SCREW SET
K120493
Instratek, Inc.
Orthopedic · 90d
Cleared May 11, 2012
HEALIX ADVANCE PEEK ANCHOR
K120449
Depuy Mitek
Orthopedic · 87d
Cleared Apr 24, 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645
Wrightmedicaltechnologyinc
Orthopedic · 53d
Cleared Apr 10, 2012
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K120390
Solana Surgical, LLC
Orthopedic · 63d
Cleared Jan 23, 2012
SYNDE-LOCK SYNDESMOSIS REPAIR KIT
K111971
Tarsus Medical, Inc.
Orthopedic · 196d
Cleared Jan 13, 2012
MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL
K112727
Medical Facets
Orthopedic · 115d
Cleared Jan 04, 2012
DYNA LOCKING CANNULATED SCREW
K112240
U&I Corp.
Orthopedic · 153d