# K230764: OsteoCentric Integrated Hip Fastener System

- Pathway: 510(k) (Special)
- Applicant: OsteoCentric Technologies
- Decided: Apr 18, 2023 after 29 days
- Product code: JDO (Device, Fixation, Proximal Femoral, Implant)
- 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: 13 generations back to K962616 (1996). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210247: OsteoCentric Integrated Hip Fastener System, Osteocentric Technologies D.B.A. Osteocentric Trauma (2021) Summary page 4.
- K182154: Depuy Synthes Femoral Neck System, Synthes (USA) Products, LLC (2018) Summary page 4.
- K062066: Omega 3 System, Howmedica Osteonics Corp. (2006) Summary page 4.
- K953607: Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS), Synthes (Usa) (1996) Summary page 4.

## Indications for use
The OsteoCentric Integrated Hip Fastener System is indicated for stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed. The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including intracapsular, transcervical, and subcapital fractures.

Source page: https://510kreport.com/device/K230764
Methodology: https://510kreport.com/methodology