# K980854: Retrograde Pediatric Nail

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Aug 11, 1998 after 159 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 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 no predicate by number.

## Most influential descendants
- K020885: Fassire-Duval Telescopic IM System (2003), 15 descendants of its own
- K041393: Fassier-Duval Telscopic IM System (2004), 14 descendants of its own
- K111232: Gap Endo-Exo Medullary System (2012), 7 descendants of its own
- K160545: Gap Endo-Exo Medullary System (2016), 6 descendants of its own
- K143355: The Simple Locking IntraMedullary (SLIM) System (2015), 6 descendants of its own

## Indications for use
The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.

Source page: https://510kreport.com/device/K980854
Methodology: https://510kreport.com/methodology