# K871539: Zindrick IM Rod

- Pathway: 510(k) (Traditional)
- Applicant: Buckman Co., Inc.
- Decided: Aug 17, 1987 after 119 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
75 later devices descend from it; 3 cite it directly.
0 of 76 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
- K013563: Long Trochanteric Nail System (2001), 70 descendants of its own
- K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems (2003), 53 descendants of its own
- K083497: Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (2009), 39 descendants of its own
- K101622: Zimmer Natural Nail System Retrograde Femoral Nails (2010), 29 descendants of its own
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own

## Recalls of this device
- Apr 1, 2016 · Class II · Z-1819-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

Source page: https://510kreport.com/device/K871539
Methodology: https://510kreport.com/methodology