510(k) · Cleared
ClearedBiomet Biaxial 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 May 5, 1998 as substantially equivalent to K883665 (Zimmer, Inc., 1989) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.
- Decided
- May 5, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861680 (1986). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K982398Biomet 100% Porous Coated Biaxial Total ElbowBiomet, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861680 | Osteonics Elbow Prosthesis | Osteonics Corp. | 1986 | — |
| 0 (this device) | K980428 | Biomet Biaxial Total Elbow | Biomet, Inc. | 1998 | — |
| +1 | K982398 | Biomet 100% Porous Coated Biaxial Total Elbow | Biomet, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K883665 | Coonrad Iii Total ElbowSummary page 2…is equivalent to almost all elbow joint metal/polymer constrained cemented prostheses on the market. Predicate devices include: Coonrad lll Total Elbow (Zimmer, 510(k) #K883665) Osteonics Elbow Prosthesis (Osteonics Corp., 510(k) #K861680) 060077 g SERVICEG W Uy C DEPARTMENT OF HEALTH &… | 1989 |
| * | K861680 | Osteonics Elbow ProsthesisSummary page 2…ned cemented prostheses on the market. Predicate devices include: Coonrad lll Total Elbow (Zimmer, 510(k) #K883665) Osteonics Elbow Prosthesis (Osteonics Corp., 510(k) #K861680) 060077 g SERVICEG W Uy C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service & <O WEALTY o & "'1:3… | 1986 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982398 | Biomet 100% Porous Coated Biaxial Total Elbow | 1998 | 0 |
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?
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 Biaxial Hinge Total Elbow is indicated for use in
Rheumatoid 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 1linked 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/K980428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980428: Biomet Biaxial Total Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980428
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