# K170106: MyKnee PPS-Pin Positioners

- Pathway: 510(k) (Special)
- Applicant: Medacta International S.A.
- Decided: Oct 20, 2017 after 281 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941847 (1994). 87 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093806: Myknee Cutting Blocks, Medacta International S.A. (2010) Summary page 4.

## Most influential descendants
- K220705: MyKnee R Pin Positioners (2022), 0 descendants of its own
- K213751: NextAR™ TKA Platform My Knee PPS (2022), 0 descendants of its own

## Indications for use
MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.

Source page: https://510kreport.com/device/K170106
Methodology: https://510kreport.com/methodology