Metal-Backed Acetabular Cup (K831479)

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

Full name

Metal-Backed Acetabular Cup

510(k) Number

K831479 ↗

FDA Product Code

DXQ

Device Class

Class II

Regulation

21 CFR Part 870.1120

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K800140 Active Cleared 3 Mar 1980

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  Class I

  FDA 510(k) K781526 Active Cleared 20 Sep 1978

• Silastic Brand Q7-2091 Gastric Sump Tube

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  FDA 510(k) K760708 Active Cleared 23 Nov 1976

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• Silastic Bone Plug H.P.(Cement Restrict)

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  FDA 510(k) K800898 Active Cleared 2 May 1980

• Implant, H.P. Condylar

  Class II

  FDA 510(k) K781870 Active Cleared 9 Feb 1979

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• What types of hip surgeries is this metal-backed acetabular cup designed for, and how does the metal backing improve performance in those procedures?

  This metal-backed acetabular cup is specifically designed for use in total hip arthroplasty procedures, where it replaces the damaged acetabulum to restore hip joint function. The metal backing provides enhanced structural reinforcement, improving stability and load-bearing capacity—critical for patients with high activity levels or those requiring durable implants, as it distributes forces more effectively than non-metal alternatives.

• Is this device intended for reuse, or is it meant to be implanted once and discarded? How is it packaged to ensure safety?

  The metal-backed acetabular cup is explicitly supplied as a single-use implant, meaning it is not designed for reuse. To maintain sterility and safety, it comes in sterile packaging, ensuring it remains uncontaminated until used in surgery. This aligns with standard orthopedic implant practices to prevent infection and ensure patient safety.

• What regulatory pathway was followed for this device, and which advisory committee reviewed its submission?

  This device followed the FDA’s 510(k) clearance pathway, classified under product code DXQ for hip joint replacements. Its submission was reviewed by the Cardiovascular Advisory Committee (CV), though it is important to note this was a procedural classification—it does not imply cardiovascular use. The clearance was granted under traditional standards, meaning it was deemed substantially equivalent to a predicate device already on the market.

• Are there different sizes or models available for this acetabular cup, and how would a surgeon determine the correct fit for a patient?

  While the provided data does not specify exact sizes or models, metal-backed acetabular cups typically come in a range of diameters and orientations to accommodate varying patient anatomies. Surgeons would use preoperative imaging (like CT or X-rays) and intraoperative assessment to select the appropriate size, ensuring proper alignment and coverage of the acetabulum for optimal function and stability.