510(k) · Cleared
ClearedVersys Epoch Fullcoat Hip Prosthesis, Model 4088 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Cleared on Aug 7, 2008 as substantially equivalent to K052321 (Zimmer, Inc., 2006) after a 238-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- Aug 7, 2008
- Review
- 238 days
- Class
- Class III
- Product code
- JDL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842906 (1984). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK842906 Bias Total HipZimmer, Inc. · 1984
- 2 generations backK014070 Epoch Hip Prosthesis, Model 4075 SeriesZimmer, Inc. · 2002
- 1 generation backK052321 Versys Epoch Fullcoat Hip ProsthesisZimmer, Inc. · 2006
- This deviceK073499 Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842906 | Bias Total Hip | Zimmer, Inc. | 1984 | — |
| −2 | K014070 | Epoch Hip Prosthesis, Model 4075 Series | Zimmer, Inc. | 2002 | — |
| −1 | K052321 | Versys Epoch Fullcoat Hip Prosthesis | Zimmer, Inc. | 2006 | — |
| 0 (this device) | K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series | Zimmer, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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 JDL? 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? (1)
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 |
|---|---|---|---|
| * | K052321 | Versys Epoch Fullcoat Hip Prosthesis | 2006 |
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 24 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All JDL devicesJDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JDL
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · JDL
Too few JDL 510(k)s in any year since 2007 to give a median.
Recalls per year · JDL
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDL
16in 2025
MAUDE reports naming product code JDL, 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 | 1 | — | 0 | 79 |
| 2008 | 1 | — | 0 | 67 |
| 2009 | 0 | — | 2 | 104 |
| 2010 | 0 | — | 1 | 198 |
| 2011 | 0 | — | 0 | 271 |
| 2012 | 0 | — | 0 | 338 |
| 2013 | 0 | — | 0 | 496 |
| 2014 | 0 | — | 0 | 519 |
| 2015 | 0 | — | 0 | 466 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 0 | — | 0 | 336 |
| 2018 | 0 | — | 0 | 205 |
| 2019 | 0 | — | 0 | 140 |
| 2020 | 0 | — | 0 | 94 |
| 2021 | 0 | — | 0 | 68 |
| 2022 | 0 | — | 0 | 49 |
| 2023 | 0 | — | 0 | 32 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The VerSys Epoch FullCoat Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
This device is intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073499: Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073499
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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