# K190216: SpaceFlex Knee

- Pathway: 510(k) (Traditional)
- Applicant: G21, S.R.L.
- Decided: Jun 9, 2019 after 125 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: 6 generations back to K936159 (1995). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161273: StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis, Biomet, Inc. (2017) Summary page 4.
- K062274: Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321, Tecres S.P.A. (2008) Summary page 4.
- K112470: 2GC Hip/Knee Modular Spacer, Mandell Horwitz Consultants, LLC (2012) Summary page 4.

## Most influential descendants
- K201960: SpaceFlex Knee - 80mm Size (2020), 0 descendants of its own

## Indications for use
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 180 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/K190216
Methodology: https://510kreport.com/methodology