# K092771: Dyna Locking IM Nail

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp.
- Decided: Dec 2, 2009 after 84 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
Longest line of descent: 1 generation back to K860756 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860756: Grosse and Kempf Locking Nail System, Non-Slot Rod, Howmedica Corp. (1986) Summary page 1.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 1.
- K933340: Osteo Interlocking-Compression Nail, Osteo AG (1994) Summary page 1.
- K081152: T2 Femoral Nail, Howmedica Osteonics Corp. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K961529: Sas Shigella Boydii Type 12 Antiserum, Sa Scientific, Inc. (1996). Our reading of the summary gave K961529, FDA’s number for Sas Shigella Boydii Type 12 Antiserum (Sa Scientific, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Delta 11 Femoral Nail”. Kept off the family tree. Summary page 2.

## Indications for use
The Dyna Locking IM NailTm is intended to be implanted into the intramedullary canal of femur or tibia for alignment, stabilization, fixation of fractures caused by trauma or disease: * Proximal, middle and distal third femoral and tibial shaft fractures * Severely comminuted, spiral and segmental fractures * Nonunions and malunions * Bone lengthening

Source page: https://510kreport.com/device/K092771
Methodology: https://510kreport.com/methodology