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Rigidfix Biocryl 210816

by Medos International Sàrl

Rigidfix Biocryl 210816 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K150209 on 6 Oct 2015 (2 earlier submissions) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI 10886705001309), active as of 23 Oct 2026. 5 FDA recalls are 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

5 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150209 Date6 Oct 2015DecidedStatusActive
United StatesGUDID listing Number10886705001309 UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150209 decided 6 Oct 2015 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10886705001309 listed 1 Sep 2015 Listed

Recalls

5 recalls · 5 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-1680-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1678-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1681-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1679-2023 FDA Class II initiated 13 Apr 2023
    • Ongoing Z-1677-2023 FDA Class II initiated 13 Apr 2023

    IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

Timeline

9 dated events

  1. Cleared FDA 510(k) K090669
  2. Cleared FDA 510(k) K091041
  3. Listed FDA GUDID 10886705001309
  4. Cleared FDA 510(k) K150209
  5. Recall initiated FDA recalls Z-1680-2023
  6. Recall initiated FDA recalls Z-1678-2023
  7. Recall initiated FDA recalls Z-1681-2023
  8. Recall initiated FDA recalls Z-1679-2023
  9. Recall initiated FDA recalls Z-1677-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rigidfix Biocryl
Generic name
Tendon/ligament bone anchor, bioabsorbable
Model / Ref / Catalog
210816
Primary DI / UDI-DI
10886705001309
510(k) Number
FDA product code
MAI, HTY, HWC, MBI, JDR
GMDN term
Tendon/ligament bone anchor, bioabsorbable
Device class
Class II
Regulation number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tendon/ligament bone anchor, bioabsorbable

Cleared under the same submission (K090669)

Cleared under the same submission (K091041)

Similar devices in this category

Other devices filed under Tendon/ligament bone anchor, bioabsorbable.

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)