510(k) · Cleared
ClearedVesafitcup Double Mobility- Highcross Hxuhmwpe Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Mar 12, 2010 as substantially equivalent to K083116 (Medacta International S.A., 2009) and 6 other predicates after a 226-day review. Its family tree reaches back 4 generations to 1997. 23 later devices descend from it.
- Decided
- Mar 12, 2010
- Review
- 226 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 4 generations to P960047 (1997). 24 ancestors in all, the oldest K861766 (1986). 23 later devices descend from it, 7 citing it directly.
- Root · 4 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- 3 generations backK021661 Ringloc Constrained LinersBiomet Orthopedics, Inc. · 2002
- 2 generations backK030923 Epsilon Durasul Constrained Acetabular LinerCenterpulse Orthopedics, Inc. · 2003
- 1 generation backK071718 Trilogy Longevity Constrained LinerZimmer, Inc. · 2007 · Recalled
- This deviceK092265 Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010
- Descendant · cites it directly · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · 2 generations on · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · 2 generations on · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
- Descendant · 2 generations on · 4 of its ownK183582 MPACT ExtensionMedacta International S.A. · 2019
- Descendant · cites it directly · 4 of its ownK103352 Versafitcup CC TrioMedacta International · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K103721Mpact Acetabular SystemMedacta International · 2011 · cites it directly21descendants
- K122641Mpact ExtensionMedacta International · 2012 · 2 generations on14descendants
- K132879Mpact ExtensionMedacta International · 2014 · 2 generations on11descendants
- K183582MPACT ExtensionMedacta International S.A. · 2019 · 2 generations on4descendants
- K103352Versafitcup CC TrioMedacta International · 2011 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| −3 | K021661 | Ringloc Constrained Liners | Biomet Orthopedics, Inc. | 2002 | — |
| −2 | K030923 | Epsilon Durasul Constrained Acetabular Liner | Centerpulse Orthopedics, Inc. | 2003 | — |
| −1 | K071718 | Trilogy Longevity Constrained Liner | Zimmer, Inc. | 2007 | 1 |
| 0 (this device) | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | Medacta International S.A. | 2010 | — |
| +1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +2 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +2 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| +2 | K183582 | MPACT Extension | Medacta International S.A. | 2019 | — |
| +1 | K103352 | Versafitcup CC Trio | Medacta International | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 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 MEH? 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 MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K083116 | Versafit Cup Double Mobility SystemSummary page 1…is 21 CFR 888.3353 Class 1I Device Product Code: MEH Predicate Devices: K0831 16 Versafitcup~m Double Mobility System K071718 Trilogy Longevity Constrained Liner… | 2009 |
| * | K071718 | Trilogy Longevity Constrained LinerSummary page 1…Class 1I Device Product Code: MEH Predicate Devices: K0831 16 Versafitcup~m Double Mobility System K071718 Trilogy Longevity Constrained Liner K061253 Reflection 3 Acetabular System… | 2007 |
| * | K061253 | Reflection 3 Acetabular SystemSummary page 1…te Devices: K0831 16 Versafitcup~m Double Mobility System K071718 Trilogy Longevity Constrained Liner K061253 Reflection 3 Acetabular System K030923 EpsilonWm Durasul® Constrained A… | 2006 |
| * | K030923 | Epsilon Durasul Constrained Acetabular LinerSummary page 1…K071718 Trilogy Longevity Constrained Liner K061253 Reflection 3 Acetabular System K030923 EpsilonWm Durasul® Constrained Acetabular liner Versafitcu T mDM HXUHMWPE Liners 510(k)… | 2003 |
| * | K021911 | Trident Crossfire Polyuethylene LinersSummary page 2…Acetabular liner Versafitcu T mDM HXUHMWPE Liners 510(k) Section 5 - Page 2 of 4 K021911 Trident®D Crossfire® Polyethylene Liners K994415 DePuy Marathon~m Crosslinked… | 2002 |
| * | K994415 | Marathon Cross-Linked Polyethylene Acetabular Cup LinersSummary page 2…510(k) Section 5 - Page 2 of 4 K021911 Trident®D Crossfire® Polyethylene Liners K994415 DePuy Marathon~m Crosslinked Polyethylene Acetabular Cup Liners K990135 Tri… | 2000 |
| * | K990135 | Trilogy Acetabular System Longevity Crosslinked PolyethyleneSummary page 2…yethylene Liners K994415 DePuy Marathon~m Crosslinked Polyethylene Acetabular Cup Liners K990135 Trilogy® Acetabular System Longevity® Crosslinked Polyethylene Liners Product Description: The Versaf… | 1999 |
What descends from it? (23)
See all 237 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103721 | Mpact Acetabular System | 2011 | 21 |
| K103352 | Versafitcup CC Trio | 2011 | 4 |
| K131458 | Mpact DM Liner Converter | 2013 | 3 |
| K120531 | Versafitcup CC Trio-Additional Liners | 2012 | 2 |
| K241461 | Mpact Constrained Liner | 2025 | 1 |
| K143453 | Mpact Double Mobility System | 2015 | 1 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | 2025 | 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 13 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 7 of the 24 ancestors have a recall of any class.
- Of its descendants, K103721 (Medacta International, 2011) has gone furthest, with 21 descendants of its own.
- 7 other devices also cite its predicate K083116.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, 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 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Versafitcup Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of: * Severely painful and/or disabled joint as a result of osteoarthritis, post traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis, * Congenital hip dysplasia * Ankylosing spondylitis * Avascular necrosis of the…
Read the full statement (102 words)
The Versafitcup Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery.
The patient should be skeletally mature.
The patient's condition should be due to one or more of:
* Severely painful and/or disabled joint as a result of osteoarthritis, post traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis,
* Congenital hip dysplasia
* Ankylosing spondylitis
* Avascular necrosis of the femoral head
* Acute traumatic fracture of the femoral head or neck
* Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
* Dislocation risks
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092265 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092265
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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