Titanium Mittelmeier Type Acetabular

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

510(k) Number

K842466 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Uniloc-Cementless & Self Tap Acetabular

  Class III

  FDA 510(k) K842518 Active Cleared 30 Jan 1985

• The Icr Knee

  Not classified

  FDA 510(k) K820719 Active Cleared 12 May 1982

• Spheristem Total Hip Prosthesis

  Class II

  FDA 510(k) K780497 Active Cleared 14 Jun 1978

• Cement Restrictor

  Class II

  FDA 510(k) K840413 Active Cleared 5 Mar 1984

• Uniloc

  Class II

  FDA 510(k) K842465 Active Cleared 19 Nov 1984

• What types of hip procedures is the Titanium Mittelmeier Type Acetabular designed for, and how does it function in those procedures?

  The Titanium Mittelmeier Type Acetabular is specifically designed for total hip arthroplasty procedures, serving as a prosthetic replacement for the acetabulum. It is a semi-constrained, metal, uncemented acetabular component, meaning it is intended to articulate with femoral components while providing stability without the need for bone cement. Its uncemented design relies on osseointegration with the patient’s bone over time, making it suitable for primary or revision hip replacements where a secure, load-bearing interface is required.

• Is this device intended for single-use or can it be reused in multiple patients?

  The Titanium Mittelmeier Type Acetabular is explicitly intended for single-patient implantation only. While it is manufactured as a reusable surgical implant, its design and regulatory classification (as a prosthetic device) dictate that it must remain sterile and dedicated to one patient per use, adhering to standard orthopedic implant protocols to prevent cross-contamination and ensure patient safety.

• What materials is the device made from, and does it require sterilization before use?

  The device is manufactured entirely from titanium, a biocompatible metal commonly used in orthopedic implants for its strength and corrosion resistance. Since it is intended for single-patient use, sterilization is not required prior to implantation—it is supplied in a sterile condition ready for surgical use, as outlined in its design and regulatory documentation.

• How is the device tracked or identified for regulatory and inventory purposes?

  The Titanium Mittelmeier Type Acetabular is associated with multiple FEI numbers (e.g., 3020282716, 3007923096) and registration numbers (e.g., 8043792) for tracking and distribution. These identifiers are used by regulatory bodies and distributors to monitor its supply chain, compliance, and recall processes. The device’s product code (KWA) and FDA classification (888.3330) further categorize it for administrative and inventory management.

• What should clinicians consider when storing or handling this device before surgery?

  Since the device is sterile and single-use, clinicians should store it in a controlled, sterile environment (e.g., a sterile tray or packaging) until immediately before use to maintain its integrity. The titanium construction means it is resistant to corrosion, but it should be handled with care to avoid scratches or damage that could compromise its performance. Always follow manufacturer guidelines for unpacking and preparation to ensure sterility and readiness for implantation.