# K152267: Remedy® Shoulder Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Osteoremedies, LLC
- Decided: Dec 15, 2015 after 126 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911686 (1991). 30 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 33 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 5.
- K112983: Spacer-S, Tecres S.P.A. (2011) Summary page 5.

## Most influential descendants
- K252443: SpaceFix Shoulder Spacer (2025), 0 descendants of its own
- K240856: Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (2024), 0 descendants of its own

## Indications for use
The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms. The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The Remedy® Shoulder Spacer 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/K152267
Methodology: https://510kreport.com/methodology