AltiVate Reverse Humeral Stem, 48mm
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190290 FDA 510(k)
- FDA Product Code
- KWS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3660 FDA 510(k)
- Regulation Number
- 888.3660 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AltiVate Reverse Humeral Stem, 48mm is a prosthesis for shoulder replacement, classified as semi-constrained and made of metal/polymer cemented material. It is part of a system with multiple stem length options and shell sizes to accommodate various humeral anatomies. This device is designed for use in reverse shoulder arthroplasty procedures.
The AltiVate Reverse Humeral Stem, 48mm is supplied as a single-use device and requires appropriate storage conditions. It received FDA 510(k) clearance on April 26, 2019, with the product code KWS and is classified as Class II under Special Controls. The device is manufactured by Encore Medical L.P. and is intended for orthopedic applications.
Frequently asked questions
What is the AltiVate Reverse Humeral Stem used for?
The AltiVate Reverse Humeral Stem, 48mm is a prosthesis designed for use in reverse shoulder arthroplasty procedures. It is classified as semi-constrained and made of metal/polymer cemented material to accommodate various humeral anatomies.
How is the AltiVate Reverse Humeral Stem supplied?
The AltiVate Reverse Humeral Stem is supplied as a single-use device and requires appropriate storage conditions. It is part of a system with multiple stem length options and shell sizes to accommodate various anatomical requirements.
What is the regulatory status of the AltiVate Reverse Humeral Stem?
The AltiVate Reverse Humeral Stem received FDA 510(k) clearance on April 26, 2019, with the product code KWS and is classified as Class II under Special Controls. It is manufactured by Encore Medical L.P. and is intended for orthopedic applications.
What are the distinguishing features of the AltiVate Reverse Humeral Stem system?
The AltiVate Reverse Humeral Stem system offers multiple stem length options and shell sizes to accommodate various humeral anatomies. The 48mm model is specifically designed as a semi-constrained prosthesis for shoulder replacement procedures.
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: AltiVate Reverse® - Enovis, AltiVate Reverse Humeral Stem, 48mm (K190290) — FDA 510 (k) | Innolitics, K190290 FDA 510 (k) - AltiVate Reverse Humeral Stem, AltiVate Reverse Humeral Stem, 48mm 510(k) K190290 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190290 | Class II | Active |
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Manufacturer
- Manufacturer
- Encore Medical L.P.
Sources (1)
- FDA 510(k) K190290 24 fields · synced Sep 23, 2026