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).

1059
Total
1059
Cleared
115d
Avg days
1977
Since
1059 devices
313–336 of 1059
Cleared Dec 11, 2001
SURGICAL DYNAMICS MENISCAL STAPLE
K013890
United States Surgical, A Division of Tyco Healthc
Orthopedic · 18d
Cleared Dec 10, 2001
REUNITE FUSION SCREW
K011451
Biomet, Inc.
Orthopedic · 213d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945
Synthes (Usa)
Orthopedic · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044
Synthes (Usa)
Orthopedic · 84d
Cleared Nov 16, 2001
INTEX SCREW
K012798
Biomet, Inc.
Orthopedic · 87d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102
Aesculap, Inc.
Orthopedic · 114d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 20, 2001
LACTOSORB 5.0 MM WASHER
K001581
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
K003816
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 07, 2001
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW
K002274
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Feb 20, 2001
SYNTHES HAMSTRING LOOP
K003700
Synthes (Usa)
Orthopedic · 81d
Cleared Feb 15, 2001
SMITH & NEPHEW SUTURE ANCHOR
K003599
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 25, 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271
Synthes (Usa)
Orthopedic · 30d
Cleared Apr 03, 2000
ASNIS III CANNULATED SCREW SYSTEM
K000080
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Feb 25, 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
K994202
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Feb 03, 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089
Synthes (Usa)
Orthopedic · 22d
Cleared Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 08, 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025
Biomet, Inc.
Orthopedic · 29d
Cleared May 14, 1999
BONE MULCH SCREW SYSTEM
K991298
Biomet, Inc.
Orthopedic · 29d
Cleared Feb 03, 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209
Biomet, Inc.
Orthopedic · 71d
Cleared Jan 28, 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K982662
DePuy Orthopaedics, Inc.
Orthopedic · 90d