# K220705: MyKnee R Pin Positioners

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 4, 2022 after 55 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: 11 generations back to K941847 (1994). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170106: MyKnee PPS-Pin Positioners, Medacta International S.A. (2017) Summary page 4.

## Indications for use
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient’s knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the pins placed in the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon’s preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® Sphere, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.

Source page: https://510kreport.com/device/K220705
Methodology: https://510kreport.com/methodology