# K932330: TI-6AL-7NB Urtn

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 8, 1996 after 1,030 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
No predicates in its family tree.
116 later devices descend from it; 4 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Unreamed Tibial Nail (stainless steel): named in the summary without a submission number

## Most influential descendants
- K990717: Fixion Intramedullary Nailing System (1999), 56 descendants of its own
- K021324: Fixion Intramedullary Nailing System (Fixion IM Nailing System) (2002), 54 descendants of its own
- K013449: Modification to Fixion Interlocking Intramedullary Nailing System (2001), 54 descendants of its own
- K043270: Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series (2005), 53 descendants of its own
- K023437: Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing System), Fixion Intramedullary Nail (2002), 53 descendants of its own

## Indications for use
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia.

Source page: https://510kreport.com/device/K932330
Methodology: https://510kreport.com/methodology