# K133285: Stryker Temporary Condylar Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Apr 9, 2014 after 166 days
- Product code: NEI (Prosthesis, Condyle, Mandibular, Temporary)
- Device class: 2
- Regulation: 21 CFR 872.4770
- Recalls of this device: none
- 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K020199: Locking Reconstruction Plate with Attachable Condylar Head. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle.

Source page: https://510kreport.com/device/K133285
Methodology: https://510kreport.com/methodology