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).
1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
Cleared
Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
United States Surgical, A Division of Tyco Healthc
Orthopedic
18d
Cleared
Dec 10, 2001
REUNITE FUSION SCREW
Biomet, Inc.
Orthopedic
213d
Cleared
Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
Biomet, Inc.
Orthopedic
116d
Cleared
Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
Synthes (Usa)
Orthopedic
90d
Cleared
Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
Synthes (Usa)
Orthopedic
84d
Cleared
Nov 16, 2001
INTEX SCREW
Biomet, Inc.
Orthopedic
87d
Cleared
Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
Aesculap, Inc.
Orthopedic
114d
Cleared
May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
Arthrex, Inc.
Orthopedic
90d
Cleared
Mar 20, 2001
LACTOSORB 5.0 MM WASHER
Biomet, Inc.
Orthopedic
302d
Cleared
Mar 09, 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
Arthrex, Inc.
Orthopedic
88d
Cleared
Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
Smith & Nephew, Inc.
Orthopedic
224d
Cleared
Feb 20, 2001
SYNTHES HAMSTRING LOOP
Synthes (Usa)
Orthopedic
81d
Cleared
Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
Smith & Nephew, Inc.
Orthopedic
86d
Cleared
Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
Howmedica Osteonics Corp.
Orthopedic
28d
Cleared
Aug 25, 2000
2.4MM CORTEX SCREW, SELF-TAPPING
Synthes (Usa)
Orthopedic
30d
Cleared
Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
Howmedica Osteonics Corp.
Orthopedic
83d
Cleared
Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
Smith & Nephew, Inc.
Orthopedic
74d
Cleared
Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
Synthes (Usa)
Orthopedic
22d
Cleared
Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
Smith & Nephew, Inc.
Orthopedic
78d
Cleared
Oct 08, 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
Biomet, Inc.
Orthopedic
29d
Cleared
May 14, 1999
BONE MULCH SCREW SYSTEM
Biomet, Inc.
Orthopedic
29d
Cleared
Feb 03, 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
Biomet, Inc.
Orthopedic
71d
Cleared
Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
Smith & Nephew, Inc.
Orthopedic
56d
Cleared
Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
DePuy Orthopaedics, Inc.
Orthopedic
90d