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Arcos 31-300817

by Biomet Orthopedics, Inc.

Arcos 31-300817 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K090757 on 25 Sep 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00880304483415), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

18 closed

Documents

510(k) K090757

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304483415 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090757 Date25 Sep 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090757 decided 25 Sep 2009 Active
  • FDA GUDID UDI-DI 00880304483415 listed 23 Sep 2016 Listed

Recalls

18 recalls · FDA

  • 17 recalls, same reason

    • Terminated Z-2272-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2267-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2264-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2266-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2269-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2274-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2259-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2262-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2270-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2273-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2265-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2271-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2260-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2263-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2275-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2261-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757
    • Terminated Z-2268-2021 FDA Class II initiated 2 Jun 2021 on shared 510(k) K090757

    Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

    • Terminated Z-2820-2018 FDA Class II initiated 8 Jun 2018

    Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

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

Timeline

20 dated events

  1. Recall initiated FDA recalls Z-2262-2021
  2. Recall initiated FDA recalls Z-2270-2021
  3. Recall initiated FDA recalls Z-2273-2021
  4. Recall initiated FDA recalls Z-2265-2021
  5. Recall initiated FDA recalls Z-2271-2021
  6. Recall initiated FDA recalls Z-2260-2021
  7. Recall initiated FDA recalls Z-2263-2021
  8. Recall initiated FDA recalls Z-2275-2021
  9. Recall initiated FDA recalls Z-2261-2021
  10. Recall initiated FDA recalls Z-2268-2021

10 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

GUDID

Trade name
Arcos
Generic name
Femoral stem prosthesis trial
Model / Ref / Catalog
31-300817
Primary DI / UDI-DI
00880304483415
510(k) Number
FDA product code
LZO, MAY, KWY, MEH, KWZ, JDI, LPH
GMDN term
Femoral stem prosthesis trial
Device class
Class II
Regulation number
888.3353, 888.3390, 888.3310, 888.3350, 888.3358
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Femoral stem prosthesis trial

Cleared under the same submission (K090757)

and 8 more cleared under K090757

Similar devices in this category

Other devices filed under Femoral stem prosthesis trial.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)