# K233873: XLO Brand of Locking Distal Humerus Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Life Systems Private Limited
- Decided: Apr 26, 2024 after 141 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: 12 generations back to K962616 (1996). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120717: Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates), Synthes USA (2012) Summary page 5.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 5.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 5.

## Indications for use
The XLO Brand of Locking Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. The system is indicated for use in adult patients only. All implants are for single use only.

Source page: https://510kreport.com/device/K233873
Methodology: https://510kreport.com/methodology