# K965175: Howmedica Mainstay Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Mar 13, 1997 after 79 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953531 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953531: Howmedica Mainstay Anchor, Howmedica Corp. (1995) Summary page 1.

## Indications for use
This device is to be used for soft tissue attachment in the shoulder, ankle, foot, wrist, hand, elbow, knee and pelvis. This present submission is being made to introduce an additional indication for use in soft tissue reconstruction following total hip arthroplasty.

Source page: https://510kreport.com/device/K965175
Methodology: https://510kreport.com/methodology