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Scorpio 72-15-0315

by Howmedica Osteonics Corp.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261898 Date6 Aug 2026DecidedStatusActive
United StatesGUDID listing Number07613154020102 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3206-2026 FDA Class II initiated 30 Jul 2026 on shared 510(k) K243817
    • Ongoing Z-3197-2026 FDA Class II initiated 30 Jul 2026

    Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

    • Ongoing Z-0883-2024 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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Scorpio
Generic name
Tibial insert
Model / Ref / Catalog
72-15-0315
Primary DI / UDI-DI
07613154020102
510(k) Number
FDA product code
JWH
GMDN term
Tibial insert
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insert

Cleared under the same submission (K041591)

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Cleared under the same submission (K243817)

Show all (12)

Cleared under the same submission (K261898)

Show all (12)

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (10)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No