Identity
- Trade Name
- Entrada Hip Stem FDA UDI
- Generic Name
- Coated hip femur prosthesis, modular FDA UDI
- Device Name
- Size 11 EXT Collarless FDA UDI
- Model / Reference
- 510-1011 FDA UDI
- Description
- Size 11 EXT Collarless FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409036097 FDA UDI
- 510(k) Number
- FDA Product Code
- MEH FDA 510(k)FDA UDILZO FDA UDIKWY FDA UDIKWL FDA UDI
- GMDN Term
- Coated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)FDA UDI888.3390 FDA UDI888.3360 FDA UDI
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Entrada hip stem is a single-piece, tapered, hydroxyapatite (HA)-coated femoral prosthesis for uncemented, press-fit fixation in the medullary canal. It features a 12/14 trunnion taper for modular femoral head attachment and is available in multiple sizes, offsets, and collar configurations.
It is used by orthopedic surgeons in clinical settings for total or hemi-hip arthroplasty. The device is supplied sterile and is intended for single-use. It has received FDA 510(k) clearance under K171249 with product code MEH.
Frequently asked questions
What is the Entrada hip stem used for?
The Entrada hip stem is used by orthopedic surgeons in clinical settings for total or hemi-hip arthroplasty. It is designed for uncemented, press-fit fixation in the medullary canal, providing stability through its tapered, hydroxyapatite-coated design and modular 12/14 trunnion taper for femoral head attachment.
How is the Entrada hip stem supplied and is it reusable?
The Entrada hip stem is supplied sterile and is intended for single-use only. This ensures sterility and prevents cross-contamination, as reusing the device could compromise its integrity and increase infection risk, which is why it is not designed for reprocessing or reuse.
What sizes and configurations are available for the Entrada hip stem?
The Entrada hip stem is available in multiple sizes, offsets, and collar configurations to accommodate varying patient anatomies and surgical needs. These options allow surgeons to select the appropriate fit for optimal stem positioning, leg length, and offset during hip arthroplasty procedures.
What regulatory pathway was used for the Entrada hip stem?
The Entrada hip stem received FDA 510(k) clearance under submission number K171249, with product code MEH. This clearance pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the United States for its intended use.
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: PDF Instructions for Use Entrada™ Hip St - odev.com, Entrada™ hip stem (K171249) — FDA 510 (k) | Innolitics, Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171249 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho Development Corporation
Sources (2)
- FDA 510(k) K171249 24 fields · synced Sep 21, 2026
- FDA UDI 35e98212-cd8f-470c-849f-935d35b0972b 35 fields · synced May 26, 2026