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I.T.S. Pelvic Reconstruction System

by I.T.S. Implantat-Technologie-Systeme GmbH

510(k) K063166

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 NumberK063166 Date22 Dec 2006ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1600-2026 FDA Class II initiated 23 Jan 2026

    Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

    • Ongoing Z-1718-2019 FDA Class II initiated 9 May 2019

    The titanium implant has the wrong article number laser marked on it.

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  • Withdrawn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
HRS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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