510(k) · Cleared
Recalled · 2011Porous Coated Discovery Elbow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Sep 6, 2005 as substantially equivalent to K013042 (Biomet Orthopedics, Inc., 2001) after a 47-day review. Its family tree reaches back 2 generations to 2001. 11 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 6, 2005
- Review
- 47 days
- Class
- Class II
- Product code
- JDC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003253 (2001). 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003253 Biomet's Minimally Constrained ElbowBiomet, Inc. · 2001
- 1 generation backK013042 Discovery ElbowBiomet Orthopedics, Inc. · 2001 · Recalled
- This deviceK051975 Porous Coated Discovery ElbowBiomet, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK153398 Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
- Descendant · 2 generations on · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018
- Descendant · cites it directly · 2 of its ownK090473 Discovery Elbow - X-SmallBiomet Manufacturing Corp · 2009
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · cites it directly7descendants
- K143659Equinoxe Mega ProsthesisExactech, Inc. · 2015 · 2 generations on5descendants
- K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016 · 2 generations on3descendants
- K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · 2 generations on2descendants
- K090473Discovery Elbow - X-SmallBiomet Manufacturing Corp · 2009 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003253 | Biomet's Minimally Constrained Elbow | Biomet, Inc. | 2001 | — |
| −1 | K013042 | Discovery Elbow | Biomet Orthopedics, Inc. | 2001 | 3 |
| 0 (this device) | K051975 | Porous Coated Discovery Elbow | Biomet, Inc. | 2005 | — |
| +1 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
| +2 | K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015 | — |
| +2 | K153398 | Comprehensive SRS/Nexel Elbow | Biomet Manufacturing Corp | 2016 | — |
| +2 | K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018 | — |
| +1 | K090473 | Discovery Elbow - X-Small | Biomet Manufacturing Corp | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K013042 | Discovery Elbow | 2001 |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| Dec 14, 2011 | Not classified | Z-1071-2012 | Process change control | A Discovery Condyle Kit w/ Hexalobula was opened during an elbow joint replacement surgery, and was found to contain two male condyles. |
| Apr 29, 2011 | Not classified | Z-2660-2011 | Packaging process control | The firm initiated this recall after becoming aware that a Discovery Condyle Kit with Hexalobula contained two male condyles instead of a male and female condyle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K111746 (Biomet, Inc., 2011) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K013042.
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 Porous Coated DiscoveryTM Elbow is intended for cemented use in patients with the following conditions:
1. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of severe functional deformity.
5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051975 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051975: Porous Coated Discovery Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051975
Report an extraction error
Are you the manufacturer?
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