Titanium Classic Compression Hip Screw System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K952697 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Hydrocell Nasal and Sinus Packs

  Class I

  FDA 510(k) K954491 Active Cleared 15 Nov 1995

• Black Oval-Top Torp/Porp

  Class II

  FDA 510(k) K934107 Active Cleared 8 Jun 1994

• Profix Conforming Plus Tibial Insert

  Class II

  FDA 510(k) K946236 Active Cleared 6 Jul 1995

• Epistaxis Nasal Balloon Catheter

  Class I

  FDA 510(k) K921199 Active Cleared 8 Jul 1992

• Geri Total Hip System

  Class II

  FDA 510(k) K905186 Active Cleared 15 Feb 1991

• Rihards Titanium Half Pin

  Class II

  FDA 510(k) K920024 Active Cleared 21 Jan 1992

See all devices from Smith & Nephew Richards, Inc. →

• What types of femoral fractures is this system designed to treat and how does it work?

  The Titanium Classic Compression Hip Screw System is specifically designed for internal fixation of femoral fractures, helping to stabilize the fracture site. It achieves this through a compression mechanism that ensures proper bone alignment, promoting optimal healing by maintaining stable fixation during recovery.

• Is this system intended for reuse or is it single-use?

  The system itself is supplied as a sterile, single-use orthopedic implant. However, the titanium components are manufactured with the intent that the surgical instruments used with this system may be reusable, adhering to standard orthopedic fixation practices.

• What materials are used in the construction of this device?

  The Titanium Classic Compression Hip Screw System is constructed entirely from titanium, a material chosen for its strength, biocompatibility, and durability in orthopedic applications.

• How should this device be stored before use?

  Since the system is supplied sterile, it should be stored in its original packaging until ready for use. Proper storage ensures sterility is maintained, and the packaging should be kept sealed and protected from contamination or damage.

• What regulatory pathway was followed for this device’s clearance?

  The Titanium Classic Compression Hip Screw System received FDA clearance through a 510(k) submission (K952697), classified under product code HWC for orthopedic fixation devices. The decision was made under the Traditional clearance type and was reviewed by the Orthopedic (OR) Advisory Committee, with a determination of Substantially Equivalent in 1995.