510(k) · Cleared
ClearedEpsilon Durasul Constrained Acetabular Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centerpulse Orthopedics, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Oct 3, 2003 as substantially equivalent to P960054 (Depuy, A Johnson & Johnson Co., 1997) and 2 other predicates after a 193-day review. Its family tree reaches back 2 generations to 1997. 31 later devices descend from it.
- Decided
- Oct 3, 2003
- Review
- 193 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P960047 (1997). 3 ancestors in all. 31 later devices descend from it, 4 citing it directly.
- Root · 2 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 1 generation backK021661 Ringloc Constrained LinersBiomet Orthopedics, Inc. · 2002
- This deviceK030923 Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc. · 2003
- Descendant · cites it directly · 28 of its ownK071718 Trilogy Longevity Constrained LinerZimmer, Inc. · 2007 · Recalled
- Descendant · cites it directly · 23 of its ownK092265 Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010
- Descendant · 2 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 3 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · 3 generations on · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K071718Trilogy Longevity Constrained LinerZimmer, Inc. · 2007 · cites it directly28descendants
- K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010 · cites it directly23descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 2 generations on21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 3 generations on14descendants
- K132879Mpact ExtensionMedacta International · 2014 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −1 | K021661 | Ringloc Constrained Liners | Biomet Orthopedics, Inc. | 2002 | — |
| 0 (this device) | K030923 | Epsilon Durasul Constrained Acetabular Liner | Centerpulse Orthopedics, Inc. | 2003 | — |
| +1 | K071718 | Trilogy Longevity Constrained Liner | Zimmer, Inc. | 2007 | 1 |
| +1 | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | Medacta International S.A. | 2010 | — |
| +2 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +3 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +3 | K132879 | Mpact Extension | Medacta International | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | P960054 | S-Rom Poly-Dial Constrained LinerSummary page 1…R 5888.33 10, reviewed by the Orthopedic Devices panel. PmDICATE DEVICES: Johnson & Johnson D e h y S-ROM Poly-Dial Constrained Liner (P960054) Stryker/Howmedica/Osteonics Omnifit Constrained Liner (P960047) Biomet Ringloc Constrained Liner (K021661) DEVICE DESCR… | 1997 |
| * | P960047 | Osteonics Constrained Acetabular InsertSummary page 1…ic Devices panel. PmDICATE DEVICES: Johnson & Johnson D e h y S-ROM Poly-Dial Constrained Liner (P960054) Stryker/Howmedica/Osteonics Omnifit Constrained Liner (P960047) Biomet Ringloc Constrained Liner (K021661) DEVICE DESCRIPTION: This device consists of two components: a liner and a ring,… | 1997 |
| * | K021661 | Ringloc Constrained LinersSummary page 1…n & Johnson D e h y S-ROM Poly-Dial Constrained Liner (P960054) Stryker/Howmedica/Osteonics Omnifit Constrained Liner (P960047) Biomet Ringloc Constrained Liner (K021661) DEVICE DESCRIPTION: This device consists of two components: a liner and a ring, which will be assembled and attached to one of… | 2002 |
What descends from it? (31)
See all 314 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071718 (Zimmer, Inc., 2007) has gone furthest, with 28 descendants of its own.
- 5 other devices also cite its predicate P960054.
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Epsilon™ Durasul® Constrained Acetabular Insert is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with…
Read the full statement (118 words)
The Epsilon™ Durasul® Constrained Acetabular Insert is intended for use in treatment of primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle, or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030923 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030923: Epsilon Durasul Constrained Acetabular Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030923
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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