510(k) · Cleared
ClearedOxford Modular Shoulder Prosthesis, 192.XXX Catalogue Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corin USA · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Mar 11, 2002 as substantially equivalent to K992119 (Biomet, Inc., 1999) after a 228-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Mar 11, 2002
- Review
- 228 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992119 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992119 Bio-Modular Shoulder SystemBiomet, Inc. · 1999 · Recalled
- This deviceK012377 Oxford Modular Shoulder Prosthesis, 192.XXX Catalogue SeriesCorin USA · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992119 | Bio-Modular Shoulder System | Biomet, Inc. | 1999 | 1 |
| 0 (this device) | K012377 | Oxford Modular Shoulder Prosthesis, 192.XXX Catalogue Series | Corin USA | 2002 | — |
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 HSD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K992119 | Bio-Modular Shoulder SystemSummary page 2…onstruction of fractures. Substantial equivalence basis Based on the following SE table, which compares the Oxford Modular Shoulder to the Biomet Bio-Modular Shoulder (K992119), and the risk analysis, the former is believed to be substantially equivalent. Features Oxford Biomet Bio- Modular Modular Shou… | 1999 |
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.
What does this lineage say?
- Its one ancestor has a recall.
- 12 other devices also cite its predicate K992119.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Oxford Modular Shoulder Prosthesis is indicated for the relief of pain and restoration of function in non-inflammatory degenerative joint disease, including:
osteoarthritis
rheumatoid arthritis
revision cases where other devices or treatments have failed
correction of functional deformity
treatment of acute fracture of the humeral head unmanageable using other treatment methods
cuff tear arthroplasty
Hemi-resurfacing is also indicated for:
humeral head fractures
avascular necrosis of the femoral head
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/K012377 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012377: Oxford Modular Shoulder Prosthesis, 192.XXX Catalogue Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012377
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026