# K010632: Butterfly Plate Function System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 31, 2001 after 90 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
422 later devices descend from it; 2 cite it directly.
1 of 423 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
- K014267: Butterfly Plate Fixation System (2002), 278 descendants of its own
- K022070: Xantus Anterior Lateral Supplemental Fixation System (2002), 277 descendants of its own
- K071416: Pyramid +4 Anterior Lumbar Spine Plate System (2007), 276 descendants of its own
- K013665: Pyramid Anterior Plate Fixation System (2002), 248 descendants of its own
- K150135: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System (2015), 228 descendants of its own

Source page: https://510kreport.com/device/K010632
Methodology: https://510kreport.com/methodology