# K203408: Summit Patella Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Endeavor Orthopaedics, LLC
- Decided: Jul 30, 2021 after 253 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K962616 (1996). 104 ancestors in all.
No later device cites it as a predicate yet.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992616: SDB Cerclage System, Pioneer Surgical Technology (1999) Summary page 4.
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need, Riverpoint Medical (2010) Summary page 4.
- K201578: DePuy Synthes Variable Angle Locking Patella Plating System, Synthes (USA) Products, LLC (2020) Summary page 4.

## Indications for use
The Summit Patella Plating System is indicated for use in surgical stabilization of patella fractures during open reduction internal fixation (ORIF) procedures in adults. Each system includes a plate, screws, surgical suture, and instruments that are provided in a sterile procedure kit and intended for single use.

Source page: https://510kreport.com/device/K203408
Methodology: https://510kreport.com/methodology