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
505–528 of 1070
Cleared Mar 14, 2008
SUB-TALAR LOK, MODEL 7-11 MM
K080280
Instratek, Inc.
Orthopedic · 39d
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 Dec 10, 2007
TWINFIX FT PK
K072785
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 70d
Cleared Dec 04, 2007
MEMOMETAL BONE ANCHORS
K071941
Memometal Technologies
Orthopedic · 144d
Cleared Nov 27, 2007
MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
K073054
Cayenne Medical, Inc.
Orthopedic · 28d
Cleared Nov 02, 2007
ACTIVASCREW
K072848
Bioretec, Ltd.
Orthopedic · 29d
Cleared Sep 20, 2007
HARPOON SUTURE ANCHOR
K071816
Biomet Sports Medicine, Inc.
Orthopedic · 80d
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 13, 2007
IFS BONE FIXATION DEVICES
K071035
Internal Fixation Systems, Inc.
Orthopedic · 123d
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 Aug 03, 2007
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K071464
Inion OY
Orthopedic · 66d
Cleared Jul 31, 2007
SUBTALAR IMPLANT
K071498
Biomet Sports Medicine, Inc.
Orthopedic · 61d
Cleared Jul 09, 2007
QWIX POSITIONING SCREW
K071639
Newdeal Sas
Orthopedic · 24d
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