510(k) · Cleared
ClearedVersys Epoch Fullcoat Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 15, 2006 as substantially equivalent to K014070 (Zimmer, Inc., 2002) after a 174-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it.
- Decided
- Feb 15, 2006
- Review
- 174 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K842906 (1984). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK842906 Bias Total HipZimmer, Inc. · 1984
- 1 generation backK014070 Epoch Hip Prosthesis, Model 4075 SeriesZimmer, Inc. · 2002
- This deviceK052321 Versys Epoch Fullcoat Hip ProsthesisZimmer, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK073499 Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073499Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesZimmer, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842906 | Bias Total Hip | Zimmer, Inc. | 1984 | — |
| −1 | K014070 | Epoch Hip Prosthesis, Model 4075 Series | Zimmer, Inc. | 2002 | — |
| 0 (this device) | K052321 | Versys Epoch Fullcoat Hip Prosthesis | Zimmer, Inc. | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K014070 | Epoch Hip Prosthesis, Model 4075 SeriesSummary page 1…21 CFR § 888.3358 Predicate Device: Epoch Hip Prosthesis, manufactured by Zimmer, Inc., K014070, cleared July 30, 2002 Device Description: The VerSys Epoch Fullcoat Hip Prosthesis is a… | 2002 |
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 |
|---|---|---|---|
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 Series | 2008 | 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?
- The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 17.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K073499 (Zimmer, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052321: Versys Epoch Fullcoat Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052321
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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