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
673–696 of 1064
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044
Synthes (Usa)
Orthopedic · 84d
Cleared Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546
Bionx Implants, Inc.
Orthopedic · 28d
Cleared Nov 20, 2001
RESORBABLE SCREW ANCHOR
K012872
Arthrotek, Inc.
Orthopedic · 85d
Cleared Nov 16, 2001
INTEX SCREW
K012798
Biomet, Inc.
Orthopedic · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 24, 2001
THE SPIN SNAP-OFF SCREW
K011946
New Deal, S.A.
Orthopedic · 64d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102
Aesculap, Inc.
Orthopedic · 114d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jul 05, 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964
Osteomed Corp.
Orthopedic · 97d
Cleared Jul 02, 2001
PLUS CANCELLOUS BONE SCREWS
K011719
Plus Orthopedics
Orthopedic · 28d
Cleared Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
K011262
New Deal, S.A.
Orthopedic · 51d
Cleared May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783
Osteomed Corp.
Orthopedic · 76d
Cleared May 25, 2001
MENISCUS ARROW SHEATH #CN1000A
K010554
Bionx Implants, Inc.
Orthopedic · 88d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525
Arthrex, Inc.
Orthopedic · 90d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633
Mitek Products
Orthopedic · 68d
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 Feb 08, 2001
BIOLOK SCREW, BIOSTEON SCREW
K003641
Biocomposites, Ltd.
Orthopedic · 73d
Cleared Sep 22, 2000
HOWMEDICA OSTEONICS SHOULDER SCREW
K002654
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 25, 2000
BIOLOK SCREW
K002070
Biocomposites, Ltd.
Orthopedic · 49d
Cleared Aug 25, 2000
2.4MM CORTEX SCREW, SELF-TAPPING
K002271
Synthes (Usa)
Orthopedic · 30d