# G21, S.R.L.

- Location (FDA's records): San Possidonio, IT
- FDA decisions: 12 (2015–2025): 12 510(k) clearances
- Product codes: MBB (5), LOD (5), NDN (1), KWY (1)
- 510(k) review time since 2016: median 154 days, against 139 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 26 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet, Inc.: 4 (https://510kreport.com/company/biomet)
- Heraeus Kulzer, Inc.: 4 (https://510kreport.com/company/heraeus-kulzer)
- Stryker Corp.: 4 (https://510kreport.com/company/stryker)
- Tecres S.P.A.: 2 (https://510kreport.com/company/tecres)
- Stryker Instruments, Instruments Div.: 2 (https://510kreport.com/company/stryker-instruments-instruments-div)
- Osteoremedies, LLC: 2 (https://510kreport.com/company/osteoremedies)
- Mandell Horwitz Consultants, LLC: 1 (https://510kreport.com/company/mandell-horwitz-consultants)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)

## Firms that cite its devices most
- Icotec AG: 1 (https://510kreport.com/company/icotec)
- G-21 S.R.L.: 1 (https://510kreport.com/company/g-21)

## Its most-cited devices
- K173494: OrthoSteady G Bone Cement (2018), cited by 2
- K190216: SpaceFlex Knee (2019), cited by 1
- K150408: V-Steady, V-Fast (2015), cited by 1
- K152557: Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (2016), cited by 1
- K202338: SpaceFlex Shoulder (2021), cited by 1

## Recent decisions
- K252443: SpaceFix Shoulder Spacer (Sep 15, 2025)
- K223441: SpaceFlex Acetabular Cup (Mar 23, 2023)
- K202338: SpaceFlex Shoulder (Feb 17, 2021)
- K201960: SpaceFlex Knee - 80mm Size (Aug 13, 2020)
- K193061: G3 40 Radiopaque Bone Cement (Mar 19, 2020)
- K193059: G1 40 Radiopaque Bone Cement (Mar 19, 2020)
- K192041: G21 SpaceFlex Hip (Oct 29, 2019)
- K190216: SpaceFlex Knee (Jun 9, 2019)

Source page: https://510kreport.com/company/g21