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
Mar 07, 2006
CSS CANNULATED SCREW SYSTEM
Orthohelix Surgical Designs, Inc.
Orthopedic
14d
Cleared
Feb 23, 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
Smith & Nephew, Inc.
Orthopedic
83d
Cleared
Feb 23, 2006
BIO-MINI REVO SUTURE ANCHOR
Conmed Linvatec
Orthopedic
64d
Cleared
Feb 23, 2006
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
Regeneration Technologies, Inc.
Orthopedic
22d
Cleared
Jan 26, 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
Arthrex, Inc.
Orthopedic
56d
Cleared
Jan 26, 2006
KOBY SURGICAL INTERNAL FIXATION SYSTEM
Koby Surgical
Orthopedic
22d
Cleared
Jan 26, 2006
NEXA COMPRESSION SCREW
Nexa Orthopedics, Inc.
Orthopedic
17d
Cleared
Jan 05, 2006
5TH METATARSAL FRACTURE SCREW
Wrightmedicaltechnologyinc
Orthopedic
57d
Cleared
Dec 14, 2005
NEXA BONE SCREW SYSTEM
Nexa Orthopedics, Inc.
Orthopedic
8d
Cleared
Dec 07, 2005
KALIX II IMPLANT, MODEL 141 0XX WITH XX
New Deal, S.A.
Orthopedic
34d
Cleared
Nov 16, 2005
STERLING INTERFERENC SCREW HT
Regeneration Technologies, Inc.
Orthopedic
76d
Cleared
Nov 07, 2005
SBI AUTOFIX
Small Bone Innovations, LLC
Orthopedic
49d
Cleared
Nov 07, 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
Arthrex, Inc.
Orthopedic
46d
Cleared
Nov 04, 2005
LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60
Sciences For Bio Materials
Orthopedic
260d
Cleared
Oct 17, 2005
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
Depuy Mitek, A Johnson & Johnson Company
Orthopedic
21d
Cleared
Sep 27, 2005
ARTHREX TENODESIS FAMILY
Arthrex, Inc.
Orthopedic
91d
Cleared
Sep 07, 2005
REFIX INTERNAL FRACTURE FIXATION SCREWS
Xtremi-T, LLC
Orthopedic
204d
Cleared
Sep 06, 2005
MBARESORB IMPLANT
Kinetikos Medical, Inc.
Orthopedic
81d
Cleared
Aug 31, 2005
TRIABSORB COMPOSITE SCREW
Advanced Biomaterials
Orthopedic
189d
Cleared
Aug 25, 2005
MATRYX INTERFERENCE SCREW
Linvatec Biomaterials, Inc.
Orthopedic
23d
Cleared
Jul 26, 2005
PLC SCREW
Smith & Nephew, Inc.
Orthopedic
68d
Cleared
Jul 11, 2005
ROI FUSION RODS & PLATES
Reiley Orthopaedics, Inc.
Orthopedic
53d
Cleared
Jul 07, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
Zimmer, Inc.
Orthopedic
69d
Cleared
Jul 07, 2005
MERETE TWISTCUT SNAP-OFF BONE SCREW
Merete Medical GmbH
Orthopedic
48d