# K990637: Synthes Locking Reconstruction Plate (LRP) with Condylar Head

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Oct 22, 1999 after 238 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.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes (USA) Locking Reconstruction Plate System: named in the summary without a submission number

## Most influential descendants
- K063181: Synthes (Usa) Condylar Head Add-on System (2007), 1 descendant of its own
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
Synthes (USA) Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for pennanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

Source page: https://510kreport.com/device/K990637
Methodology: https://510kreport.com/methodology