# K192041: G21 SpaceFlex Hip

- Pathway: 510(k) (Traditional)
- Applicant: G21, S.R.L.
- Decided: Oct 29, 2019 after 90 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: 5 generations back to K974807 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161166: StageOne Select Cement Spacer Molds for Temporary Hip Replacement, Biomet, Inc. (2016) Summary page 4.
- K031841: Spacer G Temporary Hip Prosthesis, Exactech, Inc. (2004) Summary page 4.

## Indications for use
Disposable cement spacer molds with titanjium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip prosthesis made from the SpaceFlex Hip disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). Due to the inherent mechanical limitations of the hemi-hip prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Source page: https://510kreport.com/device/K192041
Methodology: https://510kreport.com/methodology