# K871247: Kronner Universal Frame External Fixation

- Pathway: 510(k) (Traditional)
- Applicant: Kronner Medical
- Decided: May 22, 1987 after 53 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 25 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 24, 2014 · Class II · Z-1581-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1600-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1582-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1587-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1601-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1591-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1584-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1578-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1580-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1595-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1594-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1593-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1596-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1590-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1589-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1598-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1592-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1585-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1579-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1602-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1583-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1599-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1588-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1597-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod
- Apr 24, 2014 · Class II · Z-1586-2014: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for prod

Source page: https://510kreport.com/device/K871247
Methodology: https://510kreport.com/methodology