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Scorpio Nrg Knee System

by Howmedica Osteonics Corp. 2 variants

510(k) K030978

Scorpio Nrg Knee System is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K030978 on 20 Nov 2003, active as of 22 Oct 2026. 11 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030978 Date20 Nov 2003ClearedStatusActive

Official records

Recalls

11 recalls · 1 ongoing · FDA

    • Ongoing Z-0899-2024 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.

    • Terminated Z-1634-2015 FDA Class II initiated 15 Aug 2014

    The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

  • 8 recalls, same reason

    • Terminated Z-0470-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-0472-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-0471-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-0477-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-0475-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-0474-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-0473-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009
    • Terminated Z-0476-2010 FDA Unclassified (pre-2012) initiated 2 Oct 2009

    It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.

    • Terminated Z-1141-2010 FDA Unclassified (pre-2012) initiated 20 Aug 2007

    A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-0470-2010
  2. Recall initiated FDA recalls Z-0472-2010
  3. Recall initiated FDA recalls Z-0471-2010
  4. Recall initiated FDA recalls Z-0477-2010
  5. Recall initiated FDA recalls Z-0475-2010
  6. Recall initiated FDA recalls Z-0474-2010
  7. Recall initiated FDA recalls Z-0473-2010
  8. Recall initiated FDA recalls Z-0476-2010
  9. Recall initiated FDA recalls Z-1634-2015
  10. Recall initiated FDA recalls Z-0899-2024

2 earlier events are in the sections above.

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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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