# K210228: KLS Martin IPS Preprosthetic

- Pathway: 510(k) (Traditional)
- Applicant: KLS-Martin L.P.
- Decided: Jul 8, 2022 after 526 days
- Product code: ELE (Implant, Subperiosteal)
- Device class: 2
- Regulation: 21 CFR 872.3645
- 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 K801208 (1980). 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)
- K801208: Hollow Basket Titanium Dental Implant, Colmed, Ltd. (1980) Summary page 4.

## Indications for use
The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for multi-unit prostheses, such as dentures.

Source page: https://510kreport.com/device/K210228
Methodology: https://510kreport.com/methodology