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REVELATION STEM - 42-080

FDA 510(k)

Class III (US FDA 510(k))

510(k) K083651

by Encore Medical L.P.

Identifiers

510(k) Number
K083651 FDA 510(k)
FDA Product Code
KWA FDA 510(k)
Models / Variants
427-21 FDA 510(k)
42-080 FDA 510(k)
180 FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 888.3330 FDA 510(k)
Regulation Number
888.3330 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Revelation Stem, Models 427-21/42-080/180 is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). This device is designed as a metal, uncemented acetabular component intended to provide structural support and stability within the hip joint, facilitating hip arthroplasty procedures. It is engineered to interface with femoral stems, offering a semi-constrained articulation to enhance joint function and durability.

These stems are supplied as reusable surgical implants and are intended for use in orthopedic settings by trained surgeons. The devices are classified under FDA Class III and are regulated under regulation number 888.3330, with a special 510(k) clearance granted in 2009. Each model (427-21, 42-080, and 180) is tailored for specific anatomical applications, ensuring compatibility with various patient anatomies during hip replacement surgeries.

Frequently asked questions

What types of hip replacement surgeries is the Revelation Stem designed to support, and how does its semi-constrained design benefit patients?

The Revelation Stem (Models 427-21, 42-080, and 180) is a metal, uncemented acetabular component intended for use in hip arthroplasty procedures. Its semi-constrained articulation is engineered to provide enhanced stability and joint function, which can help reduce dislocation risks and improve durability for patients undergoing total hip replacements or revisions. The uncemented design avoids the need for bone cement, potentially reducing complications like loosening or infection while still offering structural support within the hip joint.

Are these stems reusable or single-use, and what considerations should surgeons keep in mind when handling them?

The Revelation Stem is explicitly described as a reusable surgical implant. Since they are intended for multiple uses in orthopedic settings, surgeons should follow strict sterilization protocols to maintain integrity and safety. Proper cleaning, sterilization, and storage procedures are critical to prevent contamination or damage between uses, ensuring consistent performance during hip replacement surgeries.

What anatomical variations does the Revelation Stem accommodate, and how do the different models (427-21, 42-080, 180) differ?

The Revelation Stem comes in three models (427-21, 42-080, and 180), each tailored to specific anatomical applications. While the exact differences in sizing or design aren’t detailed here, the variety ensures compatibility with a range of patient anatomies during hip replacement surgeries. Surgeons can select the appropriate model based on preoperative assessments to optimize fit, stability, and joint function for individual patients.

How should the Revelation Stem be stored, and are there any special handling instructions for maintaining its condition?

Since the Revelation Stem is reusable, it must be stored in a clean, dry environment to prevent corrosion or contamination. While specific storage instructions aren’t provided, best practices for reusable orthopedic implants—such as using sterile packaging, avoiding moisture exposure, and adhering to manufacturer guidelines—should be followed. Proper storage ensures the device remains sterile and functional for subsequent surgical use.

What regulatory pathway was followed for the Revelation Stem’s approval, and what does the FDA’s classification as Class III imply for its use?

The Revelation Stem received a Special 510(k) clearance from the FDA in 2009 under regulation number 888.3330, with a determination of Substantially Equivalent to a predicate device. As a Class III device, it is subject to stricter regulatory oversight due to its role in supporting critical hip joint function. This classification ensures rigorous evaluation of safety and effectiveness before clinical use, reinforcing its suitability for orthopedic surgeons performing hip arthroplasty 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: REVELATION STEM, MODEL 427-21/42-080/180 (K083651) — FDA 510(k ..., REVELATION STEM, MODEL 427-21/42-080/180 - fda.report, Revelation Stem, Model 427-21/42-080/180 - Beudamed, api.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Encore Medical L.P.

Sources (1)

  • FDA 510(k) K083651 24 fields · synced Sep 18, 2026