Arcom Polyethylene Acetabular Liners & Components
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K926107 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)
Arcom Polyethylene Acetabular Liners & Components are orthopedic devices consisting of polyethylene acetabular liners and associated components. These devices are designed for use in hip replacement surgeries to provide a bearing surface between the femoral head and the acetular shell.
The devices are supplied as single-use or reusable components, depending on the specific model. They are available in various sizes and are intended for implantation during hip arthroplasty procedures. The product has received FDA 510(k) clearance with the product code LPH and was determined to be substantially equivalent.
Frequently asked questions
What are Arcom Polyethylene Acetabular Liners used for?
Arcom Polyethylene Acetabular Liners are orthopedic devices designed for use in hip replacement surgeries to provide a bearing surface between the femoral head and the acetabular shell during hip arthroplasty procedures.
Are these devices single-use or reusable?
The devices are supplied as either single-use or reusable components depending on the specific model selected for the hip replacement procedure.
What sizes and models are available for these acetabular liners?
Arcom Polyethylene Acetabular Liners are available in various sizes to accommodate different patient anatomies and surgical requirements, though specific model details would need to be referenced from the product catalog.
What regulatory status do these devices have?
The Arcom Polyethylene Acetabular Liners have received FDA 510(k) clearance with product code LPH and were determined to be substantially equivalent to predicate devices.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K926107 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K926107 24 fields · synced Sep 23, 2026