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Wagner Revision Stem

by Intermedics Orthopedics

510(k) K960588

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960588 Date5 Aug 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wagner Revision Stem is a semi-constrained hip prosthesis designed for femoral revision surgery. It is constructed from metal, ceramic, and polymer materials and is intended for use in revision arthroplasty procedures, providing structural support and stability to the femur. This device is classified under product code LZO as a hip prosthesis, specifically for cases requiring revision due to implant failure or other complications. Its design aims to restore function and alignment in complex hip reconstructions.

The Wagner Revision Stem is supplied as a reusable medical device and is intended for use in orthopedic surgical settings. It may be used in cemented or uncemented configurations, depending on clinical assessment and patient needs. The device is regulated under FDA 510(k) clearance (K960588) and falls under Class II – Special Controls for orthopedic devices. Storage and handling must comply with standard surgical instrument protocols to maintain sterility and functionality.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Wagner Revision Stem used for?

    The Wagner Revision Stem is designed specifically for femoral revision surgery in hip arthroplasty. It is intended to replace failed implants or address complications in the femur, providing structural support and restoring function and alignment in complex hip reconstructions. Its semi-constrained design helps stabilize the joint during revision procedures.

  • Is the Wagner Revision Stem a single-use or reusable device?

    The Wagner Revision Stem is supplied as a reusable medical device. It is intended for use in orthopedic surgical settings and must be handled according to standard surgical instrument protocols to maintain sterility and functionality between procedures.

  • What materials is the Wagner Revision Stem made from?

    The Wagner Revision Stem is constructed from a combination of metal, ceramic, and polymer materials. This composite design balances durability, stability, and biocompatibility to support revision arthroplasty procedures.

  • Can the Wagner Revision Stem be used with cement or without?

    Yes, the Wagner Revision Stem can be used in either cemented or uncemented configurations. The choice depends on clinical assessment and the specific needs of the patient, such as bone quality, implant stability requirements, and surgeon preference.

  • How should the Wagner Revision Stem be stored?

    The Wagner Revision Stem must be stored and handled in compliance with standard surgical instrument protocols. Proper storage ensures sterility and functionality, as it is a reusable device intended for repeated use in orthopedic revision surgeries.