# K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws

- Pathway: 510(k) (Special)
- Applicant: Depuyacromed
- Decided: May 16, 2001 after 28 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
711 later devices descend from it; 14 cite it directly.
1 of 712 devices in its family (counting itself) has 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
- K071495: Expedium 4.5MM Spine System (2007), 539 descendants of its own
- K073364: Expedium 4.5MM Spine System (2008), 538 descendants of its own
- K082942: Modfication to: Expedium Spine System (2008), 518 descendants of its own
- K090230: Expedium Spine System (2009), 462 descendants of its own
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws (2003), 410 descendants of its own

Source page: https://510kreport.com/device/K011182
Methodology: https://510kreport.com/methodology