510(k) · Cleared
Recalled · Class II · 2014Discovery Elbow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Oct 10, 2001 as substantially equivalent to K003253 (Biomet, Inc., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 23 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 10, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- JDC
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003253 (2001). 23 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK003253 Biomet's Minimally Constrained ElbowBiomet, Inc. · 2001
- This deviceK013042 Discovery ElbowBiomet Orthopedics, Inc. · 2001
- Descendant · cites it directly · 15 of its ownK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
- Descendant · cites it directly · 11 of its ownK051975 Porous Coated Discovery ElbowBiomet, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- Descendant · 2 generations on · 8 of its ownK043505 Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005
- Descendant · 2 generations on · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · cites it directly15descendants
- K051975Porous Coated Discovery ElbowBiomet, Inc. · 2005 · cites it directly11descendants
- K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · 2 generations on9descendants
- K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005 · 2 generations on8descendants
- K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003253 | Biomet's Minimally Constrained Elbow | Biomet, Inc. | 2001 | — |
| 0 (this device) | K013042 | Discovery Elbow | Biomet Orthopedics, Inc. | 2001 | — |
| +1 | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | Biomet, Inc. | 2003 | 1 |
| +1 | K051975 | Porous Coated Discovery Elbow | Biomet, Inc. | 2005 | 2 |
| +2 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| +2 | K043505 | Discovery-Mosaic Total Humerus System | Biomet, Inc. | 2005 | — |
| +2 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
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 JDC? 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 |
|---|---|---|---|
| * | K003253 | Biomet's Minimally Constrained ElbowSummary page 1…I Elbow joint metal/polymer constrained cemented prosthesis (888.3150) 87IDC Legally Marketed Devices To Which Substantial Equivalence is Claimed: Constrained Elbow, K003253 Intended Use: The Constrained Elbow is indicated for use in the following conditions: * Non-Inflammatory Degenerative Joint Di… | 2001 |
What descends from it? (23)
See all 235 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2014 | Class II | Z-1925-2014 | Nonconforming Material/Component | Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention. |
| May 23, 2008 | Not classified | Z-0032-2009 | Packaging process control | The component in the package is not the correct size. |
| May 23, 2008 | Not classified | Z-0033-2009 | Packaging process control | The component in the package is not the correct size. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K033280 (Biomet, Inc., 2003) has gone furthest, with 15 descendants of its own.
How does its category compare?
All JDC devicesJDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDC
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JDC
Too few JDC 510(k)s in any year since 2007 to give a median.
Recalls per year · JDC
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDC
212in 2025
MAUDE reports naming product code JDC, 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 | 33 |
| 2008 | 0 | — | 2 | 47 |
| 2009 | 1 | — | 6 | 45 |
| 2010 | 0 | — | 0 | 86 |
| 2011 | 0 | — | 2 | 62 |
| 2012 | 0 | — | 2 | 79 |
| 2013 | 1 | — | 0 | 74 |
| 2014 | 0 | — | 0 | 79 |
| 2015 | 1 | — | 0 | 239 |
| 2016 | 1 | — | 0 | 176 |
| 2017 | 0 | — | 0 | 401 |
| 2018 | 0 | — | 0 | 248 |
| 2019 | 2 | — | 2 | 190 |
| 2020 | 0 | — | 0 | 179 |
| 2021 | 0 | — | 0 | 157 |
| 2022 | 0 | — | 0 | 129 |
| 2023 | 0 | — | 0 | 189 |
| 2024 | 0 | — | 0 | 175 |
| 2025 | 0 | — | 0 | 212 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Discovery Elbow is indicated for use with the following conditions:
Non-Inflammatory Degenerative Joint Disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Revisions where other treatments or devices have failed
Correction of severe functional deformity
Treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods
This device is intended to be used with bone cement.
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/K013042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013042: Discovery Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013042
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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