510(k) · Cleared
ClearedSingle Axle Total 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 Apr 30, 1999 as substantially equivalent to K955916 (Biologically Oriented Prostheses, 1996) and 2 other predicates after a 242-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Apr 30, 1999
- Review
- 242 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K810847 (1981). 8 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810847 | Pritchard Surface Replacement Elbow | Depuy, Inc. | 1981 | — |
| −1 | K972691 | Abc Total Elbow Prothesis | Biomet, Inc. | 1997 | — |
| 0 (this device) | K983036 | Single Axle Total Elbow | Biomet, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 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? (3)
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 |
|---|---|---|---|
| * | K955916 | Townley Total Elbow SystemSummary page 2…equivalent to almost all elbow joint metal/polymer cemented constrained prostheses on the market. Predicate devices include: Townley Total Elbow (Biopro, 1996, 510(k) #K955916) Osteonics Total Elbow System (Osteonics 1998, 510(k) #980502) ABC Total Elbow Prosthesis (Biomet, Inc., 1997, 510(k) #972691)… | 1996 |
| * | K980502 | Osteonics Total Elbow SystemSummary page 2…strained prostheses on the market. Predicate devices include: Townley Total Elbow (Biopro, 1996, 510(k) #K955916) Osteonics Total Elbow System (Osteonics 1998, 510(k) #980502) ABC Total Elbow Prosthesis (Biomet, Inc., 1997, 510(k) #972691) 00034 e “"’Q:.b" & . . 5. -/ DEPARTMENT OF HEA… | 1998 |
| * | K972691 | Abc Total Elbow ProthesisSummary page 2…ownley Total Elbow (Biopro, 1996, 510(k) #K955916) Osteonics Total Elbow System (Osteonics 1998, 510(k) #980502) ABC Total Elbow Prosthesis (Biomet, Inc., 1997, 510(k) #972691) 00034 e “"’Q:.b" & . . 5. -/ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service %, rena Food and Drug… | 1997 |
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?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 16.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
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 Single Axle Total Elbow is indicated for use in theumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structure about the elbow.
This device is a single use implant. It is intended for use 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/K983036 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983036: Single Axle Total Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983036
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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