# K201960: SpaceFlex Knee - 80mm Size

- Pathway: 510(k) (Special)
- Applicant: G21, S.R.L.
- Decided: Aug 13, 2020 after 30 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: 7 generations back to K936159 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190216: SpaceFlex Knee, G21, S.R.L. (2019) Summary page 4.
- K161273: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis, Biomet, Inc. (2017) Summary page 4.

## Indications for use
SpaceFlex Knee disposable cement spacer molds are indicated for use to mold a temporary Total Knee Replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of [80 days or less. Because of inherent mechanical limitations of the device material (G3A Bone Cement). the molded temporary 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/K201960
Methodology: https://510kreport.com/methodology