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Scorpio CR Superflex Tibial Insert

by Howmedica Osteonics Corp.

510(k) K011643

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 · Special NumberK011643 Date28 Jun 2001ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0884-2024 FDA Class II initiated 1 Dec 2023
    • Ongoing Z-0885-2024 FDA Class II initiated 1 Dec 2023

    Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

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  • Withdrawn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
JWH
Device class
Class II
Regulation
21 CFR Part 888.3560
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Scorpio CR Superflex Tibial Insert is a tibial bearing component designed for use in knee arthroplasty procedures. It is classified as an orthopedic device and is intended to articulate with compatible tibial trays to restore knee function in patients requiring total knee replacement.

This device is supplied as a single-use item and is regulated under FDA 510(k) clearance (K011643) through the Special 510(k) pathway. It is intended for use in sterile surgical settings and must be handled and stored according to manufacturer guidelines to maintain integrity prior to implantation.

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