Conformity Stem Extension Line
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242249 FDA 510(k)
- FDA Product Code
- LZO 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 Conformity Stem Extension Line is a femoral stem extension designed for use with hip joint prostheses. It is classified under 21 CFR 888.3353 as a semi-constrained, metal/ceramic/polymer hip prosthesis, available in cemented or nonporous uncemented configurations.
This device is intended for single-use in orthopedic surgery settings and is supplied sterile. It is intended to extend the femoral stem component of hip implants, with available standard and high-offset variants to accommodate soft tissue tensioning. The device holds an FDA 510(k) clearance under Special Review (K242249) and is manufactured by United Orthopedic Corporation.
Frequently asked questions
What types of hip implants is the Conformity Stem Extension Line designed to work with, and how does it differ between cemented and uncemented use?
The Conformity Stem Extension Line is specifically designed to extend the femoral stem component of hip joint prostheses. It is available in two configurations: cemented (for use with bone cement) and nonporous uncemented (for direct bone integration without cement). The choice between these depends on the surgeon’s preference and the patient’s clinical needs, such as bone quality or fixation requirements. Both versions maintain the same core function of extending the stem while accommodating soft tissue tensioning via standard or high-offset variants.
Is the Conformity Stem Extension Line reusable, or is it intended for single-use only? How does this affect its sterility?
The Conformity Stem Extension Line is intended for single-use only in orthopedic surgery settings. This design ensures sterility is maintained throughout its intended use, as it is supplied sterile by the manufacturer. Single-use also reduces the risk of cross-contamination and infection, which is critical in sterile surgical environments.
What are the key differences between the standard and high-offset variants of this device, and why might a surgeon choose one over the other?
The Conformity Stem Extension Line comes in standard and high-offset variants, which differ in their design to accommodate varying soft tissue tensioning requirements. The high-offset variant is longer or positioned differently to better align with the patient’s anatomy, particularly useful for cases requiring greater leg length restoration or improved soft tissue balance. A surgeon might choose the high-offset version when standard offset does not adequately address soft tissue tension or leg length discrepancies, ensuring a more stable and functional hip prosthesis.
How should the Conformity Stem Extension Line be stored, and are there any specific handling instructions to maintain its integrity?
While the exact storage instructions are not detailed in the provided data, the device is supplied sterile, so it should be stored in its original, sealed packaging until ready for use. Proper storage typically involves keeping it in a clean, dry environment protected from moisture, extreme temperatures, and physical damage. Since it is single-use, it should not be reused or restocked after opening. Always follow the manufacturer’s included instructions for handling to preserve sterility and functionality.
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: Conformity Stem Extension Line (K242249) — FDA 510 (k) | Innolitics, Conformity Stem | United Orthopedic Corporation | Hip and Knee Implants, Conformity Stem Extension Line (K242249) - Medical Device Navigator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242249 | Class II | Active |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
Sources (1)
- FDA 510(k) K242249 24 fields · synced Oct 6, 2026