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
913–936 of 1070
Cleared Jul 18, 1995
NEXMED CANCELLOUS BONE SCREWS
K951656
Nexmed, Inc.
Orthopedic · 99d
Cleared Jul 11, 1995
ANSPACH SUTURE ANCHOR
K945525
The Anspach Effort, Inc.
Orthopedic · 243d
Cleared Jul 11, 1995
ABSORBABLE ACETABULAR SCREW
K946347
Zimmer, Inc.
Orthopedic · 193d
Cleared Jul 11, 1995
OGDEN ANCHOR
K950875
American Medical Electronics, Inc.
Orthopedic · 133d
Cleared Jul 10, 1995
DEPUY SET SCREW
K950833
Depuy, Inc.
Orthopedic · 136d
Cleared Jul 05, 1995
ORTHOPEDIC SCREW FIXATION
K932350
Osteomed Corp.
Orthopedic · 782d
Cleared Jul 03, 1995
HARPOON SUTURE ANCHORS
K943806
Biomet, Inc.
Orthopedic · 333d
Cleared Jul 03, 1995
LMT BONE ANCHOR
K951233
Li Medical Technologies, Inc.
Orthopedic · 105d
Cleared Jul 03, 1995
LMT BONE ANCHOR
K951472
Li Medical Technologies, Inc.
Orthopedic · 95d
Cleared Jul 03, 1995
OGDEN ANCHOR
K951493
American Medical Electronics, Inc.
Orthopedic · 94d
Cleared Jul 03, 1995
OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS
K951545
American Medical Electronics, Inc.
Orthopedic · 95d
Cleared Jun 30, 1995
K4 BONE SCREW SYSTEM
K950704
Kinetikos Medical, Inc.
Orthopedic · 135d
Cleared Jun 27, 1995
SFC
K951303
Medpac
Orthopedic · 97d
Cleared Jun 22, 1995
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K945687
Smith and Nephew Donjoy, Inc.
Orthopedic · 213d
Cleared Jun 22, 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652
Osteotech, Inc.
Orthopedic · 129d
Cleared Jun 16, 1995
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER
K951304
Synthes (Usa)
Orthopedic · 86d
Cleared Jun 14, 1995
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS
K934590
Smith & Nephew Richards, Inc.
Orthopedic · 628d
Cleared May 17, 1995
MED-SURG SUTURE WASHER
K950250
Medical Surgical, Inc.
Orthopedic · 114d
Cleared May 10, 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321
Linvatec Corp.
Orthopedic · 614d
Cleared May 05, 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330
Acu Med, Inc.
Orthopedic · 241d
Cleared Apr 14, 1995
ARTHREX CANCELLOUS SCREW AND WASHER
K945426
Arthrex, Inc.
Orthopedic · 161d
Cleared Feb 03, 1995
AIMS CANNULATED ACL SCREW (7MM DIAMETER)
K945236
Smith and Nephew Donjoy, Inc.
Orthopedic · 99d
Cleared Feb 02, 1995
BONE MULCH SCREW
K941941
Biomet, Inc.
Orthopedic · 287d
Cleared Jan 24, 1995
DYONICS FIXATION SCREWS
K945182
Smith & Nephew Dyonics, Inc.
Orthopedic · 92d