iASSIST 20-8011-013-00
iASSIST 20-8011-013-00 is a Class II device made by Orthosoft Inc, cleared under FDA 510(k) K213033 on 14 Jan 2022 (3 earlier submissions) and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00889024305267), active as of 2 Nov 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213033 | Date14 Jan 2022 | StatusActive |
| United States | GUDID listing | Number00889024305267 | Date7 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00889024305267
- FDA 510(k) database K213033
- FDA 510(k) database K192080
- FDA 510(k) database K141601
- FDA 510(k) database K122326
Across registries
- FDA 510(k) K213033 decided 14 Jan 2022 Active
- FDA GUDID UDI-DI 00889024305267 listed 7 Sep 2016 Listed
Recalls
-
- Terminated Z-1868-2017
There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P
-
- Terminated Z-1701-2015
Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.
Timeline
- Cleared FDA 510(k) K122326
- Cleared FDA 510(k) K141601
- Recall initiated FDA recalls Z-1701-2015
- Listed FDA GUDID 00889024305267
- Recall initiated FDA recalls Z-1868-2017
- Cleared FDA 510(k) K192080
- Cleared FDA 510(k) K213033
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- iASSIST
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- 20-8011-013-00
- Primary DI / UDI-DI
- 00889024305267
- FDA product code
- OLO
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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