100KGY E-Poly Acetabular Liners – Additional Profiles: +3 Maxrom and +3 Hi-Wall
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K090103 FDA 510(k)
- FDA Product Code
- MAY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 100KGY E-Poly Acetabular Liners are classified as Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, designed for cemented or non-porous cemented fixation with an osteophilic finish. These components are intended for use as acetabular replacements in total hip arthroplasty, providing structural support and articulation within the hip joint.
These liners are supplied sterile and intended for single-use. They are compatible with MRI environments and are available in specific profiles, including +3 Maxrom and +3 Hi-Wall, to accommodate varying anatomical requirements. The device is regulated under FDA 510(k) clearance (K090103) and falls under Class II medical devices, adhering to regulatory standards for orthopedic implants. Storage and handling must comply with manufacturer guidelines to maintain sterility and integrity.
Frequently asked questions
Are these acetabular liners compatible with cemented or non-cemented hip replacements, and how does the osteophilic finish affect their use?
The 100KGY E-Poly Acetabular Liners are designed for both cemented and non-porous cemented fixation, meaning they can be used with or without bone cement during total hip arthroplasty. The osteophilic finish enhances bone integration by promoting a stronger bond between the liner and the bone surface, which can improve stability and longevity in the hip joint.
What profiles are available for these liners, and how do they differ in terms of anatomical fit?
The 100KGY E-Poly Acetabular Liners come in two additional profiles: +3 Maxrom and +3 Hi-Wall. These profiles are tailored to accommodate varying anatomical structures, with +3 Maxrom offering a slightly deeper cup for increased coverage, while +3 Hi-Wall provides a taller wall to enhance stability and support in specific patient anatomies.
How should these liners be stored to ensure sterility and integrity, and are they reusable?
These liners are supplied sterile and are intended for single-use only. To maintain sterility and integrity, storage must follow the manufacturer’s guidelines, which likely include keeping them in a sealed, sterile packaging until use. Reuse is not recommended, as it could compromise sterility and compromise patient safety.
Can these liners be used in patients who require MRI scans, and how does that compatibility affect their design?
Yes, the 100KGY E-Poly Acetabular Liners are MRI-compatible, meaning they can be safely used in patients who require magnetic resonance imaging. This compatibility is important for postoperative monitoring and follow-up care, as it avoids the need for alternative imaging modalities that may not be as effective for evaluating hip implants.
What regulatory pathway was followed for this device, and what class does it fall under?
The 100KGY E-Poly Acetabular Liners were cleared through the FDA 510(k) pathway under clearance number K090103, with a decision of Substantially Equivalent (SESE). They are classified as Class II medical devices, adhering to regulatory standards for orthopedic implants, including those related to hip prostheses.
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: 100kgy E-poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 ..., 100kgy E-poly Acetabular Liners- Additional Profiles: +3 Maxrom And +3 ..., PDF K090103 - 100kgy E-poly Acetabular Liners- Additional Profiles: +3 ..., 510 (k) K090103 — 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090103 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K090103 24 fields · synced Sep 20, 2026