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Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE

by Signature Orthopaedics Pty Limited

510(k) K133370

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 NumberK133370 Date22 Jul 2014ClearedStatusActive

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  • Withdrawn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
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
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.

This device is a hip prosthesis system comprising femoral stems and bipolar heads used in total or hemi-hip arthroplasty. The Remedy and Pegasus stems are cementless, while the Evolve stem is cemented. The system includes multiple stem models with varying offsets and sizes to allow independent adjustment of hip offset and leg length.

The device is supplied as part of a prosthesis system with 4 different offsets (35mm, 37.5mm, 44mm, 50mm) and 2 to 4 stem sizes per offset. It features a collarless design and a 12/14 taper connection for adaptation to multiple heads and taper sleeves. The device received FDA 510(k) clearance under K133370 and is classified as a prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (product code LPH), Class II with special controls.

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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 REMEDY HIP STEM system used for?

    The REMEDY HIP STEM system is used in total or hemi-hip arthroplasty as a hip prosthesis system comprising femoral stems and bipolar heads, allowing independent adjustment of hip offset and leg length through multiple stem models with varying offsets and sizes.

  • How is the REMEDY HIP STEM system supplied and what are its key design features?

    The device is supplied as part of a prosthesis system with 4 different offsets (35mm, 37.5mm, 44mm, 50mm) and 2 to 4 stem sizes per offset, featuring a collarless design and a 12/14 taper connection for adaptation to multiple heads and taper sleeves.

  • Is the REMEDY HIP STEM system cemented or cementless, and does this vary by model?

    The Remedy and Pegasus stems are cementless, while the Evolve stem is cemented, reflecting different fixation approaches within the same prosthesis system to accommodate varying surgical techniques and patient conditions.