# K060535: Spacer-S Temporary Shoulder Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: May 24, 2006 after 85 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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 K911686 (1991). 28 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042021: Exactech Equinoxe Shoulder System, Exactech, Inc. (2004) Summary page 2.

## Most influential descendants
- K112983: Spacer-S (2011), 7 descendants of its own
- K131135: Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (2014), 4 descendants of its own
- K160071: StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (2016), 3 descendants of its own
- K152267: Remedy® Shoulder Spacer (2015), 2 descendants of its own
- K202338: SpaceFlex Shoulder (2021), 1 descendant of its own

## Indications for use
Spacer-S is indicated for temporary use (maximum 180 days) as an adjunct to total shoulder replacement and hemi shoulder replacement procedures in skeletally mature patients undergoing a two-stage revision procedure due to a septic process. Spacer-S is only indicated for an implantation period of 180 days or less.

Source page: https://510kreport.com/device/K060535
Methodology: https://510kreport.com/methodology