BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
FDA 510(k) clearance K131135 · decided 2014-01-22
Clearance details
- K-number
- K131135
- Device name
- BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2013-04-22
- Decision date
- 2014-01-22
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- MBB
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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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 |
| SpaceFlex Knee (K190216) | G21, S.R.L. | 2019-06-09 |
| 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 |
Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110) | Biomet Manufacturing Corp | 2025-06-24 |
| Oxford® Partial Knee System (P010014/S107) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Cementless Partial Knee System (P010014/S105) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Partial Knee System (P010014/S108) | Biomet Manufacturing Corp | 2024-11-18 |
| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |