510(k) · Cleared
ClearedOsteonics Solar Shoulder Bipolar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MJT Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Cleared on Jul 20, 1999 after a 138-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 20, 1999
- Review
- 138 days
- Class
- Class III
- Product code
- MJT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Biomet Bi-Angular Bi-Polar Shoulder System Named without a submission number | |
| † | K955731 | Osteonics Shoulder Humeral Components | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MJT devicesMJT Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJT
FDA has decided no MJT device since 2007.
Median 510(k) review, days · MJT
Too few MJT 510(k)s in any year since 2007 to give a median.
Recalls per year · MJT
No recall names MJT since 2007.
Adverse event reports per year · MJT
6in 2022
MAUDE reports naming product code MJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 0 | 39 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The subject components of the Osteonics® Solar™ Shoulder Bipolar System are single-use devices which are sold sterile and are intended for use with only the other components of the commercially available Osteonics® Solar™ Shoulder System. The indications for the use of the Osteonics® Solar™ Shoulder Bipolar System components, in keeping with those of other legally devices are as follows: Indications: * Aseptic necrosis of the humeral head . Painful…
Read the full statement (131 words)
The subject components of the Osteonics® Solar™ Shoulder Bipolar System are single-use devices which are sold sterile and are intended for use with only the other components of the commercially available Osteonics® Solar™ Shoulder System.
The indications for the use of the Osteonics® Solar™ Shoulder Bipolar System components, in keeping with those of other legally devices are as follows:
Indications:
* Aseptic necrosis of the humeral head
. Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, theumatoid arthritis or post-traumatic arthritis.
. Proximal humeral fracture and/ot dislocation
L Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
] Pathological conditions or age considerations which indicate 2 more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990712: Osteonics Solar Shoulder Bipolar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990712
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026