Universal Self-Aligning Acetabular Com

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

510(k) Number

K834035 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Wheelchair Muff

  Class I

  FDA 510(k) K780195 Active Cleared 9 Mar 1978

• Strap, Legrest

  Class I

  FDA 510(k) K780191 Active Cleared 14 Feb 1978

• Threaded Rod Clamp

  Class I

  FDA 510(k) K781447 Active Cleared 27 Sep 1978

• Wheelchair Accessories

  Class I

  FDA 510(k) K780184 Active Cleared 13 Feb 1978

• Cup, Acetabular, Long Posterior Wall

  Class II

  FDA 510(k) K780398 Active Cleared 21 Mar 1978

• Flat Wrench

  Class I

  FDA 510(k) K781451 Active Cleared 27 Sep 1978

See all devices from Orthopedic Equipment Co., Inc. →

• What is the Universal Self-Aligning Acetabular Component designed for in a clinical setting?

  This device is specifically designed for use in total hip arthroplasty procedures, serving as a prosthetic acetabular cup. Its self-aligning mechanism helps accommodate anatomical variations in the pelvis, ensuring stable fixation and proper load distribution during hip joint function.

• Is the Universal Self-Aligning Acetabular Component intended for reuse or single-use?

  The device is supplied sterile and explicitly intended for single-use only. It must be discarded after implantation to maintain sterile integrity and prevent cross-contamination, adhering to standard surgical protocols for orthopedic implants.

• How should I store the Universal Self-Aligning Acetabular Component before use?

  Storage must follow sterile surgical instrument protocols to preserve its integrity. Since it is sterile upon supply, it should remain in its original packaging until immediately before use, protected from contamination and environmental exposure.

• What regulatory pathway was followed for FDA clearance of this device?

  The device received 510(k) clearance (K834035) under the FDA’s Traditional 510(k) review process, classified as substantially equivalent to a predicate device. The clearance was granted by the Orthopedic (OR) Advisory Committee in 1984, confirming its compliance with Class II medical device regulations.