Aufranc-Turner ATS Total Hip System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K830307 ↗

FDA Product Code

KWL

Device Class

Class II

Regulation

21 CFR Part 888.3360

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What is the primary use of the AUFRANC-TURNER ATS TOTAL HIP SYSTEM in surgical procedures?

  The AUFRANC-TURNER ATS TOTAL HIP SYSTEM is a metal femoral prosthesis specifically designed for femoral hemiarthroplasty, meaning it replaces only the femoral head (ball) of the hip joint, rather than the entire hip. This is typically used in procedures where the femoral head is damaged or lost, such as in certain fractures or degenerative conditions, to restore hip function and mobility.

• Is this device intended for single-use or can it be reused after sterilization?

  The device data does not specify reuse instructions, but the FDA 510(k) clearance and Class II orthopedic classification imply it is intended for single-use in sterile surgical procedures. Reuse of implants carries risks of contamination and mechanical failure, so standard practice for such devices is to use them once per patient. Always follow manufacturer guidelines for sterilization and handling.

• How many different sizes or models of the AUFRANC-TURNER ATS TOTAL HIP SYSTEM are available?

  The device is listed with multiple FEI (Final Establishment Identification) numbers, indicating it comes in various sizes and models to accommodate different patient anatomies. While the exact dimensions or specific sizing options aren’t detailed here, the range of FEI numbers suggests a broad selection to match femoral head diameters and neck lengths. Consult the manufacturer’s catalog or technical documentation for precise sizing charts.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The AUFRANC-TURNER ATS received FDA 510(k) clearance (K830307) under the Traditional 510(k) pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. This clearance confirms the device meets FDA safety and effectiveness requirements for Class II orthopedic implants, but it does not imply approval for specific clinical indications—only that it follows established standards for femoral hemiarthroplasty prostheses. Always verify compliance with current FDA guidelines before use.