# K800806: I.C.S. Mini & Small Fragment Set

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Apr 21, 1980 after 11 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
118 later devices descend from it; 1 cites it directly.
0 of 119 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
- K991873: Kmi Wrist Fusion System (1999), 117 descendants of its own
- K021321: Wrist Fusion Plate (2002), 113 descendants of its own
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates (2005), 92 descendants of its own
- K092670: Biodrive Micro Screw System (2009), 68 descendants of its own
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own

Source page: https://510kreport.com/device/K800806
Methodology: https://510kreport.com/methodology