SpaceFlex Knee
FDA 510(k) clearance K190216 · decided 2019-06-09
Clearance details
- K-number
- K190216
- Device name
- SpaceFlex Knee
- Applicant
- G21, S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-04
- Decision date
- 2019-06-09
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MBB
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Possidomio, IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SpaceFix Shoulder Spacer (K252443) | G21, S.R.L. | 2025-09-15 |
| GENTAFIX® (1, 3, 3MV) (K242216) | Teknimed Sas | 2024-12-18 |
| Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds (K240856) | Osartis GmbH | 2024-11-20 |
| StageOne™ Select Hip Cement Spacer Molds (K222760) | Biomet, Inc. | 2022-12-28 |
| StageOne™ Shoulder Cement Spacer Molds (K221968) | Biomet, Inc. | 2022-09-15 |
| StageOne Knee Cement Spacer Molds (K213287) | Biomet, Inc. | 2022-09-02 |
| SpaceFlex Shoulder (K202338) | G21, S.R.L. | 2021-02-17 |
| SpaceFlex Knee - 80mm Size (K201960) | G21, S.R.L. | 2020-08-13 |
| G21 SpaceFlex Hip (K192041) | G21, S.R.L. | 2019-10-29 |
| StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis (K161273) | Biomet, Inc. | 2017-01-25 |
| StageOne Select Cement Spacer Molds for Temporary Hip Replacement (K161166) | Biomet, Inc. | 2016-09-08 |
| StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (K160071) | Biomet, Inc. | 2016-06-16 |
Recalls involving this device
No recalls on record reference this clearance.