510(k) · Cleared
ClearedBiomet 100% Porous Coated 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 Aug 11, 1998 as substantially equivalent to K883665 (Zimmer, Inc., 1989) and 2 other predicates after a 32-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Aug 11, 1998
- Review
- 32 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K861680 (1986). 3 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 | K861680 | Osteonics Elbow Prosthesis | Osteonics Corp. | 1986 | — |
| −1 | K980428 | Biomet Biaxial Total Elbow | Biomet, Inc. | 1998 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | 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 III Total Elbow (Zimmer, 510(k) #K883665) Osteonics Elbow Prosthesis (Osteonics Corp., 510(k) #K861680) Biaxial Total Elbow (Biomet, Inc., 510(k) #K980428) G00050 ===… | 1989 |
| * | K861680 | Osteonics Elbow ProsthesisSummary page 2…ed cemented prostheses on the market. Predicate devices include: Coonrad III Total Elbow (Zimmer, 510(k) #K883665) Osteonics Elbow Prosthesis (Osteonics Corp., 510(k) #K861680) Biaxial Total Elbow (Biomet, Inc., 510(k) #K980428) G00050 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health… | 1986 |
| * | K980428 | Biomet Biaxial Total ElbowSummary page 2…ces include: Coonrad III Total Elbow (Zimmer, 510(k) #K883665) Osteonics Elbow Prosthesis (Osteonics Corp., 510(k) #K861680) Biaxial Total Elbow (Biomet, Inc., 510(k) #K980428) G00050 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate… | 1998 |
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 12 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K883665.
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 Biomet 100% porous coated 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 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/K982398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982398: Biomet 100% Porous Coated Biaxial 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/K982398
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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