510(k) · Cleared
ClearedVersafitcup CC Trio Extension
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 Oct 19, 2012 as substantially equivalent to K103352 (Medacta International, 2011) and 2 other predicates after a 28-day review. Its family tree reaches back 11 generations to 1994. 1 later device descends from it.
- Decided
- Oct 19, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K941847 (1994). 150 ancestors in all, the oldest K840643 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations between
- 3 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 2 generations backK103352 Versafitcup CC TrioMedacta International · 2011
- 1 generation backK120531 Versafitcup CC Trio-Additional LinersMedacta International · 2012
- This deviceK122911 Versafitcup CC Trio ExtensionMedacta International · 2012
- Descendant · cites it directly · 0 of its ownK250450 Coated hip implantsMedacta International S.A. · 2025
Show all 11 generations
- Root · 11 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 9 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 8 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 7 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 6 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 5 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 4 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 3 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 2 generations backK103352 Versafitcup CC TrioMedacta International · 2011
- 1 generation backK120531 Versafitcup CC Trio-Additional LinersMedacta International · 2012
- This deviceK122911 Versafitcup CC Trio ExtensionMedacta International · 2012
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −11 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −10 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −9 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −8 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −7 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −6 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −5 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −4 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −3 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| −2 | K103352 | Versafitcup CC Trio | Medacta International | 2011 | — |
| −1 | K120531 | Versafitcup CC Trio-Additional Liners | Medacta International | 2012 | — |
| 0 (this device) | K122911 | Versafitcup CC Trio Extension | Medacta International | 2012 | — |
| +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 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 10 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (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 |
|---|---|---|---|
| * | K103352 | Versafitcup CC TrioSummary page 1…21 CIFR 858.3353 Class 11 Device Product Codes: LZO, MEH Predicate Devices: K103352 Versafitcup CC Trio, Medacta International K1 20531 Versafitcup CC Trio - Additional Liners, Medacta International… | 2011 |
| * | K120531 | Versafitcup CC Trio-Additional LinersSummary page 1…Class 11 Device Product Codes: LZO, MEH Predicate Devices: K103352 Versafitcup CC Trio, Medacta International K1 20531 Versafitcup CC Trio - Additional Liners, Medacta International K1 03721 Mpact Acetabular System, Medacta International… | 2012 |
| * | K103721 | Mpact Acetabular SystemSummary page 1…, MEH Predicate Devices: K103352 Versafitcup CC Trio, Medacta International K1 20531 Versafitcup CC Trio - Additional Liners, Medacta International K1 03721 Mpact Acetabular System, Medacta International Versafitcup CC Trio extension 510(k) SectionS5- Pa… | 2011 |
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 |
|---|---|---|---|
| K250450 | Coated hip implants | 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 18 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 42 of the 149 ancestors have a recall of any class.
- Of its descendants, K250450 (Medacta International S.A., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103352.
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. 2012, 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 hip prosthesis is designed for cementless use in total hip arthroplasty 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…
Read the full statement (99 words)
The hip prosthesis is designed for cementless use in total hip arthroplasty 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,
hemniarthroplasty, surface replacement arthroplasty, or total hip replacement where
sufficient bone stock is present.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122911: Versafitcup CC Trio Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122911
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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