ATH Full Profile Acetabular Cup System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K954213 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 ATH Full Profile Acetabular Cup System is a Hip Prosthesis, Acetabular Component (FDA LPH classification), designed for use in total hip arthroplasty. It consists of an outer metallic shell and an ultra-high molecular weight polyethylene (UHMWPE) liner, optionally reinforced with nonporous metal alloys, to replace the damaged acetabulum. The system is engineered to provide stable fixation and articulation with femoral components, accommodating varying patient anatomies. Its modular design allows customisation of shell and liner combinations for surgical precision.
This system is supplied sterile and intended for single-use in orthopaedic surgery. It is regulated under FDA 510(k) clearance (K954213) and classified under product code LPH, with no third-party involvement. The acetabular cup is available in standard sizes, including a 28mm alumina ceramic long-neck ball variant, and may be used with or without bone cement. Storage and handling must comply with sterile surgical instrument protocols, as specified by the manufacturer.
Frequently asked questions
What is the ATH Full Profile Acetabular Cup System used for?
The ATH Full Profile Acetabular Cup System is designed specifically for total hip arthroplasty, replacing the damaged acetabulum. It provides a metallic shell with an ultra-high molecular weight polyethylene (UHMWPE) liner—optionally reinforced with nonporous metal alloys—to ensure stable fixation and articulation with femoral components. Its modular design allows surgeons to customize shell and liner combinations to match patient anatomy, improving precision during surgery.
How is the ATH Full Profile Acetabular Cup System supplied, and is it reusable?
The system is supplied sterile and intended exclusively for single-use in orthopaedic surgery. This ensures patient safety by preventing cross-contamination and maintaining sterility throughout the procedure. Reuse is not recommended or supported by the manufacturer.
What sizes and variants are available for the acetabular cup?
The system includes standard acetabular cup sizes, with a notable variant being a 28mm alumina ceramic long-neck ball option. These variants allow for flexibility in surgical planning, accommodating different patient anatomies and clinical needs. The modular design further enables pairing the cup with or without bone cement, depending on the procedure requirements.
How should the ATH Full Profile Acetabular Cup System be stored and handled?
Storage and handling must adhere to strict sterile surgical instrument protocols to preserve integrity and sterility. The manufacturer’s guidelines should be followed to prevent contamination or damage, ensuring the system remains ready for single-use in orthopaedic surgery. Improper storage could compromise performance and patient safety.
Is third-party involvement required for regulatory compliance with this device?
No, third-party involvement is not required for regulatory compliance of the ATH Full Profile Acetabular Cup System. The device is regulated under FDA 510(k) clearance (K954213) with no third-party flag indicated, meaning the manufacturer’s submission and approval process was handled independently.
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: ATH FULL PROFILE ACETABULAR CUP SYSTEM - Innolitics, ATH FULL PROFILE ACETABULAR CUP SYSTEM - Innolitics, Kinamed Ath 28mm Alumina Ceramic Long-neck Ball, PDF USOO5888205A United States Patent (19) 11 Patent Number: 5,888,205
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954213 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kinamed, Inc.
Sources (1)
- FDA 510(k) K954213 24 fields · synced Oct 1, 2026