Encompass 10×17 and 12×17 Extended Press-Fit Hip Stems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K053293 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 Encompass 10×17 and 12×17 Extended Press-Fit Hip Stems are femoral components for total hip arthroplasty, designed for uncemented, press-fit fixation within the femoral canal. These devices are intended to replace damaged or diseased hip joints, providing structural support and facilitating articulation for patients with conditions such as arthritis, fractures, or avascular necrosis.
Used in clinical settings by orthopedic surgeons, these stems are supplied sterile and intended for single-use. The product is regulated under FDA 510(k) clearance (K053293) and falls under the Orthopedic advisory committee classification. Sizes 10×17 and 12×17 are specified for extended press-fit applications, with no noted MRI safety restrictions. Storage and handling must comply with sterile medical device protocols.
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: Encompass 10*17 and 12*17 Extended Press-fit Hip Stems, PDF K053293 Encompass 10*17 and 12*17 Extended Press-fit Hip Stems, ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS 510 (k) K053293 ..., ENCOMPASS 10/12 HIP STEM (K132697) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053293 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho Development Corp.
Sources (1)
- FDA 510(k) K053293 24 fields · synced Sep 18, 2026