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Custom Flanged Acetabular Component (K983035)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983035

by Biomet, Inc.

Identifiers

510(k) Number
K983035 FDA 510(k)
FDA Product Code
LPH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3358 FDA 510(k)
Regulation Number
888.3358 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Custom Flanged Acetabular Component (K983035) is a custom-manufactured acetabular cup classified as an orthopedic implant. It is designed to address severe acetabular bone loss by providing a patient-specific solution that matches individual hip anatomy, ensuring precise fit and stability during total hip arthroplasty procedures.

This device is intended for single-use and is manufactured to be paired with Biomet’s RingLoo Acetabular Liners, though it may be used with any commercially available femoral component. It is regulated under FDA 510(k) clearance (K983035) and is supplied sterile for surgical use. The implant’s custom design is based on patient-specific CT scan data to optimize anatomical alignment and functional outcomes.

Frequently asked questions

What is the Custom Flanged Acetabular Component (K983035) used for?

This device is intended for patients experiencing severe acetabular bone loss during total hip arthroplasty. Its custom design, based on individual CT scan data, ensures a precise anatomical fit, improving stability and functional outcomes by addressing complex bone deficiencies that standard implants cannot resolve.

How is the Custom Flanged Acetabular Component supplied and prepared for surgery?

The component is supplied sterile and ready for surgical use. It is manufactured as a single-use implant, meaning each unit is intended for one surgical procedure only. The customization process relies on pre-operative CT imaging to tailor the implant to the patient’s specific anatomy, ensuring optimal alignment and fit during implantation.

Can this acetabular cup be used with any femoral component, or is it limited to Biomet’s products?

While the Custom Flanged Acetabular Component is designed to pair optimally with Biomet’s RingLoo Acetabular Liners, it is not restricted to Biomet’s femoral components. Clinicians may use it with any commercially available femoral implant, provided compatibility and surgical guidelines are followed.

Is the Custom Flanged Acetabular Component reusable, or is it intended for single-use?

This device is explicitly designed for single-use only. Its custom manufacturing process ensures sterility and precision tailored to the patient’s anatomy, making reuse unsafe and incompatible with the intended clinical application. Single-use reduces infection risks and maintains regulatory compliance.

How does the custom design of this acetabular cup differ from standard implants?

Unlike standard acetabular cups, which rely on fixed sizes and shapes, the Custom Flanged Acetabular Component is engineered using patient-specific CT scan data. This allows for a precise fit that accommodates severe bone loss, flanges for additional stability, and anatomical contours that minimize impingement and improve long-term function in complex hip replacements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Triflange Acetabular Component | Zimmer Biomet | For surgeons, CUSTOM FLANGED ACETABULAR COMPONENT (K983035) — FDA 510 (k) | Innolitics, PDF K983035 - Custom Flanged Acetabular Component

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K983035 24 fields · synced Oct 1, 2026