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