# K874400: Non-Rotating Gold Cylinder and Screw

- Pathway: 510(k) (Traditional)
- Applicant: Implant Innovations International, Inc.
- Decided: Mar 2, 1988 after 126 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K982576: Frialit-2 Aurobase Model Numbers 45-2446, 45-2456, 45-2466, 45-2476 (1998), 0 descendants of its own

## Recalls of this device
- Oct 6, 2009 · Not classified · Z-1956-2010: Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for 

Source page: https://510kreport.com/device/K874400
Methodology: https://510kreport.com/methodology