# K183228: HammerToe Compression System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jan 25, 2019 after 66 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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: 5 generations back to K960385 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171715: HammerTube System, Paragon 28 (2018) Summary page 4.
- K130859: Hammertoe Correction System, Arthrosurface, Inc. (2013) Summary page 4.

## Indications for use
The HammerToe Compression System is indicated for use in the stabilization and inter-digital reconstruction of the phalanges of the foot, appropriate for the size of the device. The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-wires are indicated as guide pins for insertion of instruments and implants in the HammerToe Compression System.

Source page: https://510kreport.com/device/K183228
Methodology: https://510kreport.com/methodology