510(k) · Cleared
Recalled · Class II · 2011Versafit Cup Double Mobility System
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 Apr 7, 2009 as substantially equivalent to K070278 (Plus Orthopedics AG, 2007) and 1 other predicate after a 168-day review. Its family tree reaches back 2 generations to 1999. 59 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 7, 2009
- Review
- 168 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991990 (1999). 3 ancestors in all. 59 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK991990 Tri-Polar SystemBiomet, Inc. · 1999
- 1 generation backK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- This deviceK083116 Versafit Cup Double Mobility SystemMedacta International S.A. · 2009
- Descendant · cites it directly · 24 of its ownK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- Descendant · cites it directly · 23 of its ownK092265 Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010
- Descendant · 2 generations on · 22 of its ownK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
- Descendant · 2 generations on · 21 of its ownK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015 · Recalled
- Descendant · cites it directly · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K101336E1 Avantage HeadBiomet Manufacturing Corp · 2011 · cites it directly24descendants
- K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010 · cites it directly23descendants
- K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · 2 generations on22descendants
- K150522G7 Dual Mobility SystemBiomet, Inc. · 2015 · 2 generations on21descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · cites it directly21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| −1 | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| 0 (this device) | K083116 | Versafit Cup Double Mobility System | Medacta International S.A. | 2009 | — |
| +1 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| +1 | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | Medacta International S.A. | 2010 | — |
| +2 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
| +2 | K150522 | G7 Dual Mobility System | Biomet, Inc. | 2015 | 1 |
| +1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K070278 | Polarcup Dual Mobility SystemSummary page 1…prosthesis 21 CFR 888.3353 Class II Device Product Code: MEH Predicate Devices: K070278 POLARCUP® Dual Mobility System K072020 Restoration Tm ADM System Product Description: The Vers~fit Cu… | 2007 |
| * | K072020 | Restoration Adm SystemSummary page 1…Class II Device Product Code: MEH Predicate Devices: K070278 POLARCUP® Dual Mobility System K072020 Restoration Tm ADM System Product Description: The Vers~fit Cup Double Mobility Acetabular Component is a two piece modular desi… | 2007 |
What descends from it? (59)
See all 598 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101336 | E1 Avantage Head | 2011 | 24 |
| K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | 2010 | 23 |
| K103721 | Mpact Acetabular System | 2011 | 21 |
| K110135 | Polarcup Dual Mobility System | 2011 | 14 |
| K103352 | Versafitcup CC Trio | 2011 | 4 |
| K131458 | Mpact DM Liner Converter | 2013 | 3 |
| K143453 | Mpact Double Mobility System | 2015 | 1 |
| K111981 | Tregor Dual Mobility Acetabular System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2011 | Not classified | Z-2709-2011 | Labeling False and Misleading | Medacta International has recently realized that the base of the Liner Inserter Ref 01.26.10.0018 Lot 105549 of the Versafitcup Double Mobility system could become rusty after the washing procedures. This is due to an incorrect raw… |
| Jan 15, 2010 | Class II | Z-0878-2013 | Process control | Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K101336 (Biomet Manufacturing Corp, 2011) has gone furthest, with 24 descendants of its own.
- 7 other devices also cite its predicate K070278.
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. 2009, 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 Versafit Cup 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 (103 words)
The Versafit Cup 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
a 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/K083116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083116: Versafit Cup Double Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083116
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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