# K070843: Synthes Adolescent Lateral Entry Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 2, 2007 after 36 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.
19 later devices descend from it; 5 cite it directly.
0 of 20 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) Smith & Nephew's Adolescent Nail: named in the summary without a submission number
- (no number) Biomet's Pediatric Locking Nail System: named in the summary without a submission number

## Most influential descendants
- K111232: Gap Endo-Exo Medullary System (2012), 7 descendants of its own
- K160545: Gap Endo-Exo Medullary System (2016), 6 descendants of its own
- K083726: Pedinail Intramedullary Nailing System (2009), 6 descendants of its own
- K172583: OrthoPediatrics PediNail Intramedullary Platform (2018), 4 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own

## Indications for use
Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions in adolescent and small stature adult patients.

Source page: https://510kreport.com/device/K070843
Methodology: https://510kreport.com/methodology