# K211789: restor3d Pin Implants

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D
- Decided: Jan 4, 2022 after 208 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: 4 generations back to K901456 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181180: OSSIO™ Pin Product Family, OSSIO, Ltd. (2019) Summary page 4.

## Indications for use
restor3d Pin Implants are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Source page: https://510kreport.com/device/K211789
Methodology: https://510kreport.com/methodology