510(k) · Cleared
ClearedDiscovery Elbow - X-Small
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Mar 25, 2009 as substantially equivalent to K013042 (Biomet Orthopedics, Inc., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Mar 25, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003253 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK003253 Biomet's Minimally Constrained ElbowBiomet, Inc. · 2001
- 2 generations backK013042 Discovery ElbowBiomet Orthopedics, Inc. · 2001 · Recalled
- 1 generation backK051975 Porous Coated Discovery ElbowBiomet, Inc. · 2005 · Recalled
- This deviceK090473 Discovery Elbow - X-SmallBiomet Manufacturing Corp · 2009
- Descendant · cites it directly · 1 of its ownK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK222807 TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003253 | Biomet's Minimally Constrained Elbow | Biomet, Inc. | 2001 | — |
| −2 | K013042 | Discovery Elbow | Biomet Orthopedics, Inc. | 2001 | 3 |
| −1 | K051975 | Porous Coated Discovery Elbow | Biomet, Inc. | 2005 | 2 |
| 0 (this device) | K090473 | Discovery Elbow - X-Small | Biomet Manufacturing Corp | 2009 | — |
| +1 | K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019 | 1 |
| +2 | K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 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? (2)
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 ElbowSummary page 1…21 CFR 888.3150) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate device is the Discovery TM Elbow, originally cleared through 510(k) K013042, on October 10, 2001 and modified on through 510(k) K051975 cleared on September 6, 2005. Device Description: The Discovery M… | 2001 |
| * | K051975 | Porous Coated Discovery ElbowSummary page 1…ial Equivalence Is Claimed: The predicate device is the Discovery TM Elbow, originally cleared through 510(k) K013042, on October 10, 2001 and modified on through 510(k) K051975 cleared on September 6, 2005. Device Description: The Discovery M ' Elbow is a total elbow prosthesis comprised of an ulnar an… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181362 | TEMA Elbow System | 2019 | 1 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K181362 (Lima Corporate S.P.A., 2019) has gone furthest, with 1 descendant 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. 2009, this device’s year, is highlighted.
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 - X-Small 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 functional deformity,
5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090473: Discovery Elbow - X-Small.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090473
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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