510(k) · Cleared
ClearedAcclaim Total Elbow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Apr 14, 2006 as substantially equivalent to K992656 (DePuy Orthopaedics, Inc., 1999) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Apr 14, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K872084 (1987). 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 | K872084 | Porocoat Mark II Total Elbow | Depuy, Inc. | 1987 | — |
| −1 | K992656 | Depuy Total Elbow System | DePuy Orthopaedics, Inc. | 1999 | 2 |
| 0 (this device) | K060696 | Acclaim Total Elbow System | DePuy Orthopaedics, Inc. | 2006 | — |
Other ancestors 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 |
|---|---|---|---|
| * | K992656 | Depuy Total Elbow SystemSummary page 1…ed, Cemented (Class I1) SUBSTANTIALLY EQUIVALENT DEVICES: Acclaim tm Total Elbow System - K992656 (formerly cleared as DePuy Total Elbow System)… | 1999 |
| * | K872084 | Porocoat Mark II Total ElbowSummary page 1…m - K992656 (formerly cleared as DePuy Total Elbow System) Mark II Elbow System - K872084 DEVICE DESCRIPTION: C. Indications for Use: The Acclaim TM Total Elbow System is indicated to reduce pain and improve t… | 1987 |
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 19 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K992656.
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 AcclaimTM Total Elbow System is indicated to reduce pain and improve the function and mobility of the afficted joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components. Total Elbow replacement may be considered for younger patients, if, in the opinion of the…
Read the full statement (136 words)
The AcclaimTM Total Elbow System is indicated to reduce pain and improve the function and mobility of the afficted joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.
Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.
The AcclaimM Total Elbow System is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060696: Acclaim Total Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060696
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