StageOne™
8 catalogue numbers from 432160, listed by Biomet Orthopedics, United States, under Bone Cement, Antibiotic. 1 manufacturer in China is registered for this product code.
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | MBB |
| Device type | Bone Cement, Antibiotic |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| 510(k) | K050210 |
| Record published | 2022-09-07 |
| Record revised | 2025-05-30 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 432160 | M/L 60mm A/P 43mm | In distribution |
| 433170 | M/L 70mm A/P 42mm | In distribution |
| 431414 | Ø14mm Stem Ø64mm Head 58mm Head Width 24mm Head Thickness | In distribution |
| 432170 | M/L 70mm A/P 52mm | In distribution |
| 433175 | M/L 75mm A/P 45mm | In distribution |
| 433180 | M/L 80mm A/P 48mm | In distribution |
| 431412 | Ø12mm Stem Ø64mm Head 54mm Head Width 21mm Head Thickness | In distribution |
| 431408 | Ø8mm Stem Ø53mm Head 46mm Head Width 18mm Head Thickness | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remedy Spacer | Osteoremedies, LLC | 28 |
| CeMend Shoulder Spacer Mold | G21 SRL | 12 |
| Palacos® | Heraeus Medical LLC | 8 |
| SpaceFlex Shoulder | G21 SRL | 6 |
| Interspace Tapered Wedge Stem | Tecres SPA | 6 |
| InterSpace Hip | Tecres SPA | 6 |
| Surespace | Ortho Development Corp. | 5 |
| Prostalac | Depuy Orthopaedics, Inc. | 4 |
| CeMend Shoulder Spacer | G21 SRL | 4 |
| Rally | Smith & Nephew, Inc. | 3 |
| Smartset | Depuy (Ireland) | 3 |
| SpaceFlex Knee | G21 SRL | 3 |
Showing 12 of 44. All products under Bone Cement, Antibiotic
Recalls Naming This Product
13 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
| Biomet, Inc. | 510(k) number | 2020-02-26 | Class II | Process control | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. | 230,001 | 2021-07-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.