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).

1064
Total
1064
Cleared
115d
Avg days
1977
Since
1064 devices
457–480 of 1064
Cleared Jul 14, 2008
CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
K072291
Conmed Linvatec
Orthopedic · 333d
Cleared Jul 01, 2008
TLS FIXATION SYSTEM
K080974
Fournitures Hospitalieres Industrie
Orthopedic · 88d
Cleared Jun 20, 2008
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
K081428
Biocomposites, Ltd.
Orthopedic · 30d
Cleared Jun 11, 2008
BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS
K080088
Biomet Manufacturing, Inc.
Orthopedic · 149d
Cleared May 01, 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071
Synthes (Usa)
Orthopedic · 16d
Cleared Apr 23, 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943
Synthes (Usa)
Orthopedic · 20d
Cleared Apr 10, 2008
DARCO HEADLESS COMPRESSION SCREW
K080850
Wrightmedicaltechnologyinc
Orthopedic · 15d
Cleared Mar 25, 2008
AAP CANNULATED SCREW AND DARCO HEADED SCREW
K080101
Aap Implantate AG
Orthopedic · 71d
Cleared Mar 12, 2008
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE
K080352
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 30d
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509
Smith & Nephew, Inc.
Orthopedic · 82d
Cleared Feb 19, 2008
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM
K073426
Cayenne Medical, Inc.
Orthopedic · 76d
Cleared Nov 27, 2007
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
K073054
Cayenne Medical, Inc.
Orthopedic · 28d
Cleared Sep 17, 2007
STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
K071157
Stryker Endoscopy
Orthopedic · 145d
Cleared Sep 12, 2007
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
K071437
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 112d
Cleared Sep 10, 2007
SBI TWISTOFIX
K071541
Small Bone Innovations, Inc.
Orthopedic · 97d
Cleared Aug 31, 2007
DOMINATOR
K072127
Biocomposites, Ltd.
Orthopedic · 29d
Cleared Aug 29, 2007
SBI FOREFOOT SET
K063635
Small Bone Innovations, Inc.
Orthopedic · 266d
Cleared Aug 27, 2007
SBI ARTFIX
K071656
Small Bone Innovations, Inc.
Orthopedic · 90d
Cleared Aug 14, 2007
GRAFTLOCK SCREW, ST SCREW
K071952
Biocomposites, Ltd.
Orthopedic · 29d
Cleared Aug 09, 2007
PEEK KNOTLESS ANCHORS
K070389
Biomet Sports Medicine, Inc.
Orthopedic · 181d
Cleared Aug 09, 2007
HEALIX ANCHOR
K071481
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 72d
Cleared Jun 29, 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
K071177
Arthrex, Inc.
Orthopedic · 63d
Cleared Jun 14, 2007
CANNULATED SCREW
K070617
Fournitures Hospitalieres Industrie
Orthopedic · 101d
Cleared May 17, 2007
MODIFICATION TO BILOK SCREW
K071091
Biocomposites, Ltd.
Orthopedic · 29d