# K171715: HammerTube System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28
- Decided: Mar 5, 2018 after 269 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961522 (1996). 5 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131459: Aap K-Wire, Steinmann Pin, Cerclage Wire, Aap Implantate AG (2013) Summary page 5.

## Most influential descendants
- K231231: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices (2023), 1 descendant of its own
- K262722: Primal K-Wire (P99-193-1410) (2026), 0 descendants of its own
- K241262: Baby Gorilla/Gorilla Plating System; Monster Screw System (2024), 0 descendants of its own
- K223184: Phantom Metatarsal Shortening System (2022), 0 descendants of its own
- K202777: VeriFixx™ Small Bone Implant (2020), 0 descendants of its own

## Recalls of this device
- May 26, 2022 · Class II · Z-1468-2022: Due to Titanium plasma coating not present implant.

## Indications for use
The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint. 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 HammerTube™ System.

Source page: https://510kreport.com/device/K171715
Methodology: https://510kreport.com/methodology