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
385–408 of 1064
Cleared Dec 22, 2011
COLS PEEK
K113591
Fournitures Hospitalieres Industrie
Orthopedic · 17d
Cleared Dec 20, 2011
IFS SUBTALAR IMPLANT
K113399
Internal Fixation Systems, Inc.
Orthopedic · 33d
Cleared Dec 19, 2011
ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
K110895
Ortho Solutions Limited
Orthopedic · 264d
Cleared Dec 19, 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885
Zimmer, Inc.
Orthopedic · 80d
Cleared Dec 13, 2011
HEADLESS COMPRESSION SCREW
K112672
Skeletal Dynamics, LLC
Orthopedic · 90d
Cleared Dec 12, 2011
OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
K112658
Osteospring Medical, Inc.
Orthopedic · 90d
Cleared Dec 09, 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028
Globus Medical, Inc.
Orthopedic · 147d
Cleared Dec 09, 2011
RENOVIS CANNULATED SCREW SYSTEM
K113084
Renovis Surgical Technologies, LLC
Orthopedic · 52d
Cleared Dec 06, 2011
DISCO SUBTALAR IMPLANT
K111834
Trilliant Surgical, Ltd.
Orthopedic · 160d
Cleared Dec 05, 2011
SYNTHES CORTICAL SCREWS
K112583
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Nov 29, 2011
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K111908
Biomet Microfixation, Inc.
Orthopedic · 147d
Cleared Oct 20, 2011
TIGER HEADLESS CANNULATED SCREWS
K112737
Trilliant Surgical, Ltd.
Orthopedic · 30d
Cleared Oct 11, 2011
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
K111994
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Oct 07, 2011
ORTHOLOC(TM) BONE SCREWS
K112772
Wrightmedicaltechnologyinc
Orthopedic · 14d
Cleared Oct 05, 2011
ZIMMER PERIARTICULAR SCREWS
K111447
Zimmer, Inc.
Orthopedic · 134d
Cleared Sep 02, 2011
MICROSUTURE ANCHORS
K112237
Arthrex, Inc.
Orthopedic · 29d
Cleared Aug 29, 2011
SLIC SCREW REPAIR SYSTEM
K111608
Acumed, LLC
Orthopedic · 81d
Cleared Aug 19, 2011
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM
K111799
Ascension Orthopedic
Orthopedic · 53d
Cleared Aug 09, 2011
METASURG SUBTALAR IMPLANT
K111265
Metasurg
Orthopedic · 97d
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