# K252443: SpaceFix Shoulder Spacer

- Pathway: 510(k) (Traditional)
- Applicant: G21, S.R.L.
- Decided: Sep 15, 2025 after 42 days
- Product code: MBB (Bone Cement, Antibiotic)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911686 (1991). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202338: SpaceFlex Shoulder, G21, S.R.L. (2021) Summary page 6.
- K152267: Remedy® Shoulder Spacer, Osteoremedies, LLC (2015) Summary page 6.

## Indications for use
The SpaceFix Shoulder Spacer is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing a total or hemi shoulder arthroplasty revision due to prosthetic joint infection. The device is indicated for use when the infecting organism is sensitive to gentamicin, as the PMMA bone cement includes gentamicin for local antibiotic delivery. Following prosthesis explantation and thorough debridement, the device is implanted in the glenoid cavity and humeral canal. At the conclusion of the temporary implantation period (not to exceed 180 days), the device must be removed and either replaced with a definitive shoulder prosthesis or alternative surgical intervention (e.g., resection arthroplasty, fusion).

Source page: https://510kreport.com/device/K252443
Methodology: https://510kreport.com/methodology