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).
1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
Cleared
Aug 09, 2011
METASURG SUBTALAR IMPLANT
Metasurg
Orthopedic
97d
Cleared
Jul 28, 2011
N-FORCE FIXATION SYSTEM
Innovision, Inc.
Orthopedic
328d
Cleared
Jul 28, 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
Parcus Medical, LLC
Orthopedic
108d
Cleared
Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
Synthes (Usa)
Orthopedic
145d
Cleared
Jul 21, 2011
METASURG DIGIFUSE IMPLANT
Metasurg
Orthopedic
49d
Cleared
Jul 20, 2011
AAP CANNULATED SCREWS
Aap Implantate AG
Orthopedic
71d
Cleared
Jul 12, 2011
PRO FIXATION SYSTEM
Synovis Orthopedic & Woundcare
Orthopedic
137d
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
Feb 08, 2011
TRILLIANT SURGICAL SUBTALAR IMPLANT
Trilliant Surgical, Ltd.
Orthopedic
103d
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 23, 2010
LOCKING BONE SCREW MODEL HCQ04, HCZ04
Changzhou Orthmar Medical Instrument Co., Ltd.
Orthopedic
253d
Cleared
Nov 23, 2010
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
Emerge Medical
Orthopedic
98d
Cleared
Nov 22, 2010
CSTS SCREW
Orthopro, LLC
Orthopedic
418d
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
Nov 08, 2010
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
Medshape Solutions
Orthopedic
132d