# K063181: Synthes (Usa) Condylar Head Add-on System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 5, 2007 after 78 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
Longest line of descent: 1 generation back to K990637 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990637: Synthes Locking Reconstruction Plate (LRP) with Condylar Head, Synthes (Usa) (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K020199: Stryker Leibinger, 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.

## Most influential descendants
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

Source page: https://510kreport.com/device/K063181
Methodology: https://510kreport.com/methodology