# K223184: Phantom Metatarsal Shortening System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Dec 16, 2022 after 65 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962616 (1996). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203011: Monster Screw System, Paragon 28, Inc. (2020) Summary page 5.
- K171715: HammerTube System, Paragon 28 (2018) Summary page 5.

## Indications for use
The Phantom Metatarsal Shortening System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Metatarsal and phalangeal osteotomies Metatarsal deformity correction Hammertoe Revision hammertoe Claw toe Mallet toe Proximal Interphalangeal Joint Arthrodesis Distal Interphalangeal Joint Arthrodesis

Source page: https://510kreport.com/device/K223184
Methodology: https://510kreport.com/methodology