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