# K951116: Acromed Pedicle Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Aug 11, 1995 after 154 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.
416 later devices descend from it; 4 cite it directly.
0 of 417 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
- K963639: Acromed Pedicle Screw (1996), 414 descendants of its own
- K982511: Depuy Motech Moss Miami Spinal Systems (1998), 413 descendants of its own
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws (2003), 410 descendants of its own
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System (2007), 180 descendants of its own
- K093077: Zodiac Polyaxial Spinal Fixation System (2009), 170 descendants of its own

Source page: https://510kreport.com/device/K951116
Methodology: https://510kreport.com/methodology