510(k) · Cleared
ClearedVersafitcup CC Trio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 11, 2011 as substantially equivalent to K993082 (Exactech, Inc., 1999) and 5 other predicates after an 87-day review. Its family tree reaches back 9 generations to 1994. 4 later devices descend from it.
- Decided
- Feb 11, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K941847 (1994). 121 ancestors in all, the oldest K840643 (1984). 4 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations between
- 3 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 2 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 1 generation backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- This deviceK103352 Versafitcup CC TrioMedacta International · 2011
- Descendant · cites it directly · 2 of its ownK120531 Versafitcup CC Trio-Additional LinersMedacta International · 2012
- Descendant · cites it directly · 1 of its ownK122911 Versafitcup CC Trio ExtensionMedacta International · 2012
- Descendant · cites it directly · 0 of its ownK251043 Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A. · 2026
- Descendant · cites it directly · 0 of its ownK250450 Coated hip implantsMedacta International S.A. · 2025
Show all 9 generations
- Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 7 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 6 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 5 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 4 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 3 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 2 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 1 generation backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- This deviceK103352 Versafitcup CC TrioMedacta International · 2011
Most influential descendants
Showing 4 of 4 · See all- K120531Versafitcup CC Trio-Additional LinersMedacta International · 2012 · cites it directly2descendants
- K122911Versafitcup CC Trio ExtensionMedacta International · 2012 · cites it directly1descendant
- K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A. · 2026 · cites it directly0descendants
- K250450Coated hip implantsMedacta International S.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −8 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −7 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −6 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −4 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −3 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −2 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −1 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| 0 (this device) | K103352 | Versafitcup CC Trio | Medacta International | 2011 | — |
| +1 | K120531 | Versafitcup CC Trio-Additional Liners | Medacta International | 2012 | — |
| +1 | K122911 | Versafitcup CC Trio Extension | Medacta International | 2012 | — |
| +1 | K251043 | Mpact 3D Metal Implants Extension – DMLS Technology | Medacta International S.A. | 2026 | — |
| +1 | K250450 | Coated hip implants | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 9 | 0 |
| 1996 | 11 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 10 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K993082 | Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentSummary page 2…prosthesis Versafitcup® CC Trio 5 10O(k) Section 5 - Page 1 of 4 February 8, 2011 Predicate Devices: K993082 Exactech AcuMatchTM Integrated Hip System A-Series Porous Coated Acetabular… | 1999 |
| * | K050262 | U2 Acetabular ComponentSummary page 2…egrated Hip System A-Series Porous Coated Acetabular Component K050262 U2 Acetabular Component K083 116 Versafitcup@ Double Mobility Acetabular… | 2005 |
| * | K083116 | Versafit Cup Double Mobility SystemSummary page 2…es Porous Coated Acetabular Component K050262 U2 Acetabular Component K083 116 Versafitcup@ Double Mobility Acetabular Family, Medacta International… | 2009 |
| * | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersSummary page 2…K083 116 Versafitcup@ Double Mobility Acetabular Family, Medacta International K092265 Versafitcupt Double Mobility HighCross® UHMWPE Liners, Medacta International… | 2010 |
| * | K091069 | Medacta Bone Screws - Evolis and VersafitSummary page 2…K092265 Versafitcupt Double Mobility HighCross® UHMWPE Liners, Medacta International K09 1069 Medacta Bone Screws, Medacta International K003758 Allofit Acetabular Cup, Zimmer Product Descrip… | 2009 |
| * | K003758 | Allofit Acetabular SystemSummary page 2…UHMWPE Liners, Medacta International K09 1069 Medacta Bone Screws, Medacta International K003758 Allofit Acetabular Cup, Zimmer Product Description: The Versafitcupg CC Trio family of acetabular components is designed to be u… | 2001 |
What descends from it? (4)
4 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 17 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 39 of the 120 ancestors have a recall of any class.
- Of its descendants, K120531 (Medacta International, 2012) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K993082.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The Versafitcup® CC Trio is intended for cementiess use in total hip arthropfasty 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, or ankylosing spondylitis. * Avascular necrosis of the femoral head. *…
Read the full statement (102 words)
The Versafitcup® CC Trio is intended for cementiess use in total hip arthropfasty 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, or 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, hemniarthroplasty, surface replacement arthropiasty, or total hip replacement where sufficient bone stock is present.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103352: Versafitcup CC Trio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103352
Report an extraction error
Are you the manufacturer?
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