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
937–960 of 1070
Cleared Dec 09, 1994
6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW
K944213
Howmedica Corp.
Orthopedic · 102d
Cleared Dec 08, 1994
BONE SCREW
K943804
Cohort Medical Products Group, Inc.
Orthopedic · 126d
Cleared Dec 05, 1994
CORTICAL BONE SCREW
K942340
Acu Med, Inc.
Orthopedic · 203d
Cleared Dec 05, 1994
CANNULATED CANCELLOUS BONE SCREW
K942341
Acu Med, Inc.
Orthopedic · 203d
Cleared Nov 28, 1994
PIONEER LABORATORIES CABLE SCREW
K941866
Pioneer Surgical Technology
Orthopedic · 224d
Cleared Nov 22, 1994
PIONEER LABORATORIES BONE SCREW
K940690
Pioneer Surgical Technology
Orthopedic · 279d
Cleared Oct 19, 1994
AIMS CANNULATED ACL SCREW
K943539
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 14, 1994
CANNULATED BONE SCREW
K943474
Cohort Medical Products Group, Inc.
Orthopedic · 87d
Cleared Oct 07, 1994
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
K934366
Mitek Surgical Products, Inc.
Orthopedic · 395d
Cleared Sep 30, 1994
INTERFERENCE SCREW
K943160
Applied Osteo Systems, Inc.
Orthopedic · 91d
Cleared Sep 19, 1994
PIONEER LABORATORIES CABLE PIN
K941174
Pioneer Surgical Technology
Orthopedic · 189d
Cleared Sep 01, 1994
STAPLE, FIXATION BONE
K931155
Roseburg SA
Orthopedic · 541d
Cleared Aug 01, 1994
ARTHROTEK SET SCREW
K932721
Biomet, Inc.
Orthopedic · 423d
Cleared Jul 12, 1994
TITANIUM ALLOY BONE SCREWS
K940207
Aesculap, Inc.
Orthopedic · 179d
Cleared May 17, 1994
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K933719
Linvatec Corp.
Orthopedic · 288d
Cleared May 04, 1994
AMSET(TM) CANNULATED BONE SCREW
K931538
Advanced Med/Surg, Inc.
Orthopedic · 401d
Cleared May 04, 1994
CANNULATED CANCELLOUS SCREW
K931680
Onyx Medical Corp.
Orthopedic · 394d
Cleared Apr 28, 1994
ACE 6.5 MM BONE SCREW
K931652
Ace Medical Co.
Orthopedic · 388d
Cleared Apr 25, 1994
CANNULATED NAVICULAR SCREW
K931681
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
CORTICAL BONE SCREW
K931790
Onyx Medical Corp.
Orthopedic · 378d
Cleared Apr 25, 1994
CANCELLOUS BONE SCREW
K934615
Onyx Medical Corp.
Orthopedic · 210d
Cleared Apr 25, 1994
CANCELLOUS BONE SCREW
K934616
Onyx Medical Corp.
Orthopedic · 210d
Cleared Apr 15, 1994
BONE OR INTERFERENCE SCREW
K935836
Endo Surgical Concepts, Inc.
Orthopedic · 129d
Cleared Mar 10, 1994
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K932862
Smith and Nephew Donjoy, Inc.
Orthopedic · 272d