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., Wrightmedicaltechnologyinc and Synthes (Usa).

1070
Total
1070
Cleared
115d
Avg days
1977
Since
1070 devices
409–432 of 1070
Cleared Aug 09, 2011
METASURG SUBTALAR IMPLANT
K111265
Metasurg
Orthopedic · 97d
Cleared Jul 28, 2011
N-FORCE FIXATION SYSTEM
K102528
Innovision, Inc.
Orthopedic · 328d
Cleared Jul 28, 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
K111000
Parcus Medical, LLC
Orthopedic · 108d
Cleared Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592
Synthes (Usa)
Orthopedic · 145d
Cleared Jul 21, 2011
METASURG DIGIFUSE IMPLANT
K111536
Metasurg
Orthopedic · 49d
Cleared Jul 20, 2011
AAP CANNULATED SCREWS
K111316
Aap Implantate AG
Orthopedic · 71d
Cleared Jul 12, 2011
PRO FIXATION SYSTEM
K110538
Synovis Orthopedic & Woundcare
Orthopedic · 137d
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 Feb 08, 2011
TRILLIANT SURGICAL SUBTALAR IMPLANT
K103183
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
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 23, 2010
LOCKING BONE SCREW MODEL HCQ04, HCZ04
K100721
Changzhou Orthmar Medical Instrument Co., Ltd.
Orthopedic · 253d
Cleared Nov 23, 2010
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
K102343
Emerge Medical
Orthopedic · 98d
Cleared Nov 22, 2010
CSTS SCREW
K093055
Orthopro, LLC
Orthopedic · 418d
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 Nov 08, 2010
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER
K101808
Medshape Solutions
Orthopedic · 132d