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
409–432 of 1064
Cleared Jun 02, 2011
APTUS CANNULATED COMPRESSION SCREWS
K110658
Medartis AG
Orthopedic · 87d
Cleared May 24, 2011
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230
Synthes USA Products, LLC
Orthopedic · 22d
Cleared May 17, 2011
STERILE STORM (R) OPERATING KIT
K111001
Intelligent Orthopaedics, Ltd.
Orthopedic · 36d
Cleared May 04, 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324
Wrightmedicaltechnologyinc
Orthopedic · 260d
Cleared Apr 11, 2011
LATARJET CORTICAL SCREW SET
K110763
T.A.G. Medical Products Corporation, Ltd.
Orthopedic · 24d
Cleared Mar 18, 2011
LOW PROFILE SCREWS
K103705
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 17, 2011
FLEXFUSION (TM) FIXATION IMPLANT
K110445
Nextremity Solutions, LLC
Orthopedic · 29d
Cleared Mar 11, 2011
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
K103712
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
Cleared Jan 07, 2011
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
K102298
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 147d
Cleared Dec 21, 2010
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
K102410
Conmed Linvatec
Orthopedic · 119d
Cleared Nov 15, 2010
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR
K102326
Parcus Medical, LLC
Orthopedic · 90d
Cleared Nov 10, 2010
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR
K102162
Parcus Medical, LLC
Orthopedic · 100d
Cleared Oct 20, 2010
PIONEER CANNULATED SCREW SYSTEM
K102903
Pioneer Surgical Technology, Inc.
Orthopedic · 20d
Cleared Oct 12, 2010
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
K101700
Extremity Medical, LLC
Orthopedic · 117d
Cleared Sep 10, 2010
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
K101696
Zimmer, Inc.
Orthopedic · 86d
Cleared Jul 23, 2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
K101165
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Jun 24, 2010
DARCO HEADED CANNULATED SCREW
K100359
Wrightmedicaltechnologyinc
Orthopedic · 132d
Cleared Jun 03, 2010
MODIFICATION TO HBS HEADLESS BONE SCREW
K101030
Biopro, Inc.
Orthopedic · 51d
Cleared May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Apr 28, 2010
EXTREMITY MEDICAL SCREW SYSTEM
K093770
Extremity Medical, LLC
Orthopedic · 141d
Cleared Mar 19, 2010
OPUS SPEEDSCREW SYSTEM
K100457
Arthrocare Corp.
Orthopedic · 30d
Cleared Mar 17, 2010
OMNITECH LARGE, TRIMED COMPRESSION SCREW
K093676
TriMed, Inc.
Orthopedic · 110d
Cleared Mar 17, 2010
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819
K100532
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 20d
Cleared Jan 19, 2010
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
K092754
Small Bone Innovations, Inc.
Orthopedic · 132d