# K161254: Renovo Life Small Bone IM Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Renovo Life, LLC
- Decided: Nov 7, 2016 after 188 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960642 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 4.
- K081452: Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System, Synthes (Usa) (2008) Summary page 4.
- K143276: Acumed Small Bone IM Nail System, Acumed, LLC (2015) Summary page 4.

## Indications for use
The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.

Source page: https://510kreport.com/device/K161254
Methodology: https://510kreport.com/methodology