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
529–552 of 1064
Cleared Mar 07, 2006
CSS CANNULATED SCREW SYSTEM
K060428
Orthohelix Surgical Designs, Inc.
Orthopedic · 14d
Cleared Feb 23, 2006
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
K053344
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Feb 23, 2006
BIO-MINI REVO SUTURE ANCHOR
K053561
Conmed Linvatec
Orthopedic · 64d
Cleared Feb 23, 2006
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
K060253
Regeneration Technologies, Inc.
Orthopedic · 22d
Cleared Jan 26, 2006
ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS
K053338
Arthrex, Inc.
Orthopedic · 56d
Cleared Jan 26, 2006
KOBY SURGICAL INTERNAL FIXATION SYSTEM
K060026
Koby Surgical
Orthopedic · 22d
Cleared Jan 26, 2006
NEXA COMPRESSION SCREW
K060071
Nexa Orthopedics, Inc.
Orthopedic · 17d
Cleared Jan 05, 2006
5TH METATARSAL FRACTURE SCREW
K053136
Wrightmedicaltechnologyinc
Orthopedic · 57d
Cleared Dec 14, 2005
NEXA BONE SCREW SYSTEM
K053394
Nexa Orthopedics, Inc.
Orthopedic · 8d
Cleared Dec 07, 2005
KALIX II IMPLANT, MODEL 141 0XX WITH XX
K053093
New Deal, S.A.
Orthopedic · 34d
Cleared Nov 16, 2005
STERLING INTERFERENC SCREW HT
K052405
Regeneration Technologies, Inc.
Orthopedic · 76d
Cleared Nov 07, 2005
SBI AUTOFIX
K052576
Small Bone Innovations, LLC
Orthopedic · 49d
Cleared Nov 07, 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
K052607
Arthrex, Inc.
Orthopedic · 46d
Cleared Nov 04, 2005
LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60
K050407
Sciences For Bio Materials
Orthopedic · 260d
Cleared Oct 17, 2005
ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052630
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 21d
Cleared Sep 27, 2005
ARTHREX TENODESIS FAMILY
K051726
Arthrex, Inc.
Orthopedic · 91d
Cleared Sep 07, 2005
REFIX INTERNAL FRACTURE FIXATION SCREWS
K050388
Xtremi-T, LLC
Orthopedic · 204d
Cleared Sep 06, 2005
MBARESORB IMPLANT
K051611
Kinetikos Medical, Inc.
Orthopedic · 81d
Cleared Aug 31, 2005
TRIABSORB COMPOSITE SCREW
K050468
Advanced Biomaterials
Orthopedic · 189d
Cleared Aug 25, 2005
MATRYX INTERFERENCE SCREW
K052080
Linvatec Biomaterials, Inc.
Orthopedic · 23d
Cleared Jul 26, 2005
PLC SCREW
K051310
Smith & Nephew, Inc.
Orthopedic · 68d
Cleared Jul 11, 2005
ROI FUSION RODS & PLATES
K051309
Reiley Orthopaedics, Inc.
Orthopedic · 53d
Cleared Jul 07, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098
Zimmer, Inc.
Orthopedic · 69d
Cleared Jul 07, 2005
MERETE TWISTCUT SNAP-OFF BONE SCREW
K051323
Merete Medical GmbH
Orthopedic · 48d