# K011529: T2 Humeral Nail System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 12, 2001 after 26 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 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
- K033878: Ace Antegrade Retrograde Humeral Nail System (2004), 10 descendants of its own
- K181827: Affixus Natural Nail System Humeral Nail (2018), 6 descendants of its own
- K231114: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (2023), 4 descendants of its own
- K241651: Affixus Tibial and Antegrade Femoral Nailing System (2024), 2 descendants of its own
- K200814: Affixus (R) Natural Nail (R) System Humeral Nail (2020), 1 descendant of its own

## Recalls of this device
- May 7, 2020 · Class II · Z-2377-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2378-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured
- May 7, 2020 · Class II · Z-2376-2020: Seal integrity of the blister pack may be compromised and sterility cannot be assured

Source page: https://510kreport.com/device/K011529
Methodology: https://510kreport.com/methodology