# K951725: Osteonics Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 8, 1995 after 147 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
264 later devices descend from it; 16 cite it directly.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013688: Modification to Xia Spinal System (2001), 205 descendants of its own
- K063428: Xia Stainless Steel Spinal System (2006), 204 descendants of its own
- K052181: Modification to Xia Spinal System (2005), 202 descendants of its own
- K070631: Device Modification to Radius Spinal System (2007), 201 descendants of its own
- K082608: Radius Spinal System, Vitallium Rod #486613601 (2008), 200 descendants of its own

Source page: https://510kreport.com/device/K951725
Methodology: https://510kreport.com/methodology
