Uniloc-Cementless & Self Tap Acetabular

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

510(k) Number

K842518 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Titanium Mittelmeier Type Acetabular

  Class III

  FDA 510(k) K842466 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 surgeries is the UniLoc Cementless & Self Tap Acetabular designed for, and how does its self-tapping feature benefit the procedure?

  The UniLoc Cementless & Self Tap Acetabular is specifically designed for hip arthroplasty, a surgical procedure to replace a damaged hip joint. Its self-tapping mechanism allows the acetabular component to be screwed directly into the patient’s pelvic bone, eliminating the need for bone cement. This feature simplifies implantation, reduces surgical time, and promotes faster integration with the bone by enhancing primary stability through mechanical fixation.

• How many sizes and configurations are available for the UniLoc Cementless & Self Tap Acetabular, and how are they identified?

  The device comes in multiple sizes and configurations, each identified by a unique FEI (Final Establishment Identifier) number. Over 50 distinct FEI numbers are listed, such as 3020282716, 3007923096, and 1000116912, ensuring compatibility with a wide range of patient anatomies and surgical requirements. These variations allow surgeons to select the optimal fit for individual cases.

• Is the UniLoc Cementless & Self Tap Acetabular intended for single-use or can it be reused? How is it supplied?

  The UniLoc Cementless & Self Tap Acetabular is supplied sterile and is intended for single-use only, as is standard for implantable medical devices. It is not designed for reuse, and its sterile packaging ensures safety for one-time surgical use only.

• What storage conditions should be followed for the UniLoc Cementless & Self Tap Acetabular to maintain its integrity before use?

  While the device’s specific storage instructions aren’t detailed in the provided data, standard practices for sterile, implantable orthopedic devices apply. It should be stored in a clean, dry environment, protected from moisture, extreme temperatures, and direct sunlight. The sterile packaging must remain unopened until immediately before use to preserve sterility and functionality.

• What regulatory pathway was followed for FDA clearance of the UniLoc Cementless & Self Tap Acetabular, and what does this mean for clinicians?

  The device received FDA clearance through a 510(k) premarket notification process (K842518) under regulation 888.3330, with a decision of Substantially Equivalent (SESE) granted in 1985. This means the FDA determined it is as safe and effective as a legally marketed predicate device (though the specific predicate isn’t named here). Clinicians can rely on this clearance as evidence of the device’s compliance with FDA standards for semi-constrained metal uncemented acetabular components in hip arthroplasty.