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Modified to Modular FR Severe Bone Loss Trauma

by Sulzermedica

510(k) K002324

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Special NumberK002324 Date24 Aug 2000ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0861-2012 FDA Unclassified (pre-2012) initiated 15 Nov 2011

    Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site.

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  • Withdrawn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
JDI
Device Class
Class II
Regulation
21 CFR Part 888.3350
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 prosthesis, hip, semi-constrained, metal/polymer, cemented, as defined in the regulatory classification. It is intended for use in orthopedic applications involving severe bone loss trauma.

It was cleared via FDA 510(k) process under K002324, with a decision date of August 24, 2000. The device is classified under product code JDI and reviewed by the Orthopedic advisory committee. It is supplied as a cemented hip prosthesis for use in trauma cases with severe bone loss.

Other devices from Sulzermedica

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 MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA device used for?

    This device is a cemented hip prosthesis intended for orthopedic applications involving severe bone loss trauma, providing semi-constrained stability with metal/polymer articulation for patients requiring reconstruction after traumatic bone deficiency.

  • How is the MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA prosthesis supplied and is it reusable?

    The device is supplied as a cemented hip prosthesis for single-use implantation in trauma cases with severe bone loss; it is not designed for reuse due to wear, sterilization constraints, and regulatory classification as a permanent implant.

  • What regulatory pathway cleared the MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA device and when?

    The device received FDA 510(k) clearance under K002324 on August 24, 2000, following a determination of substantial equivalence to a predicate device, as documented in its decision description and clearance type.