# K112983: Spacer-S

- Pathway: 510(k) (Traditional)
- Applicant: Tecres S.P.A.
- Decided: Dec 12, 2011 after 67 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: 5 generations back to K911686 (1991). 29 ancestors in all.
7 later devices descend from it; 4 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)
- K060535: Spacer-S Temporary Shoulder Spacer, Tecres S.P.A. (2006) Summary page 2.

## Most influential descendants
- 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
- K252443: SpaceFix Shoulder Spacer (2025), 0 descendants of its own

## Indications for use
Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Source page: https://510kreport.com/device/K112983
Methodology: https://510kreport.com/methodology