# K103002: Synthes Multiloc Proximal Humeral Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 2, 2011 after 145 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951740 (1995). 13 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033071: Synthes (Usa) Cannulated Titanium Humeral Nail System, Synthes (Usa) (2003) Summary page 1.
- K082754: Aequalis Humeral Nail System, Tornier (2009) Summary page 1.
- K090241: Synthes Angular Stable Locking System (Asls), Synthes (Usa) (2009) Summary page 1.
- K000089: Synthes 4.0 and 5.0 MM Locking Screws, Synthes (Usa) (2000) Summary page 1.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.

## Most influential descendants
- K120807: Synthes Multiloc Humeral Nailing System (2012), 15 descendants of its own
- K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail (2014), 10 descendants of its own
- K161327: Syntec Humeral Nail System (2017), 3 descendants of its own
- K192003: Auxein Nailing System (2020), 2 descendants of its own
- K181296: Syntec Femoral Nail System (2019), 2 descendants of its own

## Recalls of this device
- May 22, 2012 · Class II · Z-2059-2012: Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
- May 22, 2012 · Class II · Z-2060-2012: Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.

## Indications for use
Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.

Source page: https://510kreport.com/device/K103002
Methodology: https://510kreport.com/methodology