# K081747: Modification to Synthes (Usa) Condylar Head Add-on System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 5, 2008 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes (USA) Condylar Head Add-on-System: named in the summary without a submission number

## 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 temporomandibularjoint disease (TMD).

Source page: https://510kreport.com/device/K081747
Methodology: https://510kreport.com/methodology