510(k) · Cleared
ClearedBiocore9 Humeral Resurfacing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocore9, LLC · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on May 15, 2020 as substantially equivalent to K992394 (Endotec, Inc., 1999) after a 185-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- May 15, 2020
- Review
- 185 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992394 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992394 Buechel-Pappas Humeral Head Resurfacing ComponentEndotec, Inc. · 1999
- This deviceK193122 Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992394 | Buechel-Pappas Humeral Head Resurfacing Component | Endotec, Inc. | 1999 | — |
| 0 (this device) | K193122 | Biocore9 Humeral Resurfacing System | Biocore9, LLC | 2020 | — |
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 |
|---|---|---|---|
| * | K992394 | Buechel-Pappas Humeral Head Resurfacing ComponentSummary page 4…ng Head Classification Name and Reference: 21 CFR 888.3690, Class II HSD Device Product Code, Device Panel: Buechel-Pappas, Humeral Head Resurfacing Component 510(k) #K 992394 Predicate Device: L ¢ BIGCORES Device Description K193122 Page 2/2 The Biocore9 Humeral Head Resurfacing comp… | 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 no recall.
- 1 other device also cites its predicate K992394.
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. 2020, this device’s year, is highlighted.
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 Biocore9 Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or
severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device,
the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or
reconstructable rotator cuff is important for proper functioning and dislocation resistance. Porous-coated components are
intended for cemented use only. This device is indicated for hemi-arthroplasty only.
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/K193122 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193122: Biocore9 Humeral Resurfacing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193122
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026