510(k) · Cleared
ClearedVersacem Acetabular Shell and Double Mobility HC Liners
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 6, 2025 as substantially equivalent to K111572 (Serf, 2011) and 3 other predicates after a 259-day review. Its family tree reaches back 13 generations to 1994.
- Decided
- Mar 6, 2025
- Review
- 259 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K941847 (1994). 148 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations between
- 3 generations backK122641 Mpact ExtensionMedacta International · 2012
- 2 generations backK131458 Mpact DM Liner ConverterMedacta International · 2013
- 1 generation backK143453 Mpact Double Mobility SystemMedacta International · 2015
- This deviceK241767 Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A. · 2025
Show all 13 generations
- Root · 13 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 11 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 10 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 9 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 8 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 7 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 6 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 5 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 4 generations backK103721 Mpact Acetabular SystemMedacta International · 2011
- 3 generations backK122641 Mpact ExtensionMedacta International · 2012
- 2 generations backK131458 Mpact DM Liner ConverterMedacta International · 2013
- 1 generation backK143453 Mpact Double Mobility SystemMedacta International · 2015
- This deviceK241767 Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −12 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −11 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −10 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −9 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −8 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −7 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −6 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −5 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| −4 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| −3 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| −2 | K131458 | Mpact DM Liner Converter | Medacta International | 2013 | — |
| −1 | K143453 | Mpact Double Mobility System | Medacta International | 2015 | — |
| 0 (this device) | K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | 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 | 2 | 0 |
| 1994 | 10 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 13 | 0 |
| 2001 | 8 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Summary page 5…Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • NOVAE® Stick Dual Mobility Acetabular Cup, K111572, Serf Reference predicate devices: • Double Mobility HighCross® highly crosslinked UHMWPE, K092265, Medacta… | 2011 |
| * | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersSummary page 5…• NOVAE® Stick Dual Mobility Acetabular Cup, K111572, Serf Reference predicate devices: • Double Mobility HighCross® highly crosslinked UHMWPE, K092265, Medacta International SA • Double Mobility HighCross® highly crosslinked UHMWPE, K131458, Medacta… | 2010 |
| * | K131458 | Mpact DM Liner ConverterSummary page 5…Double Mobility HighCross® highly crosslinked UHMWPE, K092265, Medacta International SA • Double Mobility HighCross® highly crosslinked UHMWPE, K131458, Medacta International SA • Double Mobility HighCross highly crosslinked UHMWPE Liners, K143453, Medact… | 2013 |
| * | K143453 | Mpact Double Mobility SystemSummary page 5…Mobility HighCross® highly crosslinked UHMWPE, K131458, Medacta International SA • Double Mobility HighCross highly crosslinked UHMWPE Liners, K143453, Medacta International SA • Medacta Bipolar Head, K091967, Medacta International SA… | 2015 |
| † | K091967 | Medacta Bipolar Head | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 44 of the 147 ancestors have a recall of any class.
- 9 other devices also cite its predicate K111572.
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. 2025, 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?
Versacem is designed for use In total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases: Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia. Avascular necrosis of the femoral head. Acute traumatic fracture of the femoral head or neck. Failure of previous hip surgery: joint reconstruction, internal…
Read the full statement (134 words)
Versacem is designed for use In total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases:
Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia.
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, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases:
Elderly patients or poor bone quality.
Revision for recurrent dislocation in elderly patients with poor bone quality.
Patients treated with radiotherapy or chemotherapy.
Versacem is intended for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241767: Versacem Acetabular Shell and Double Mobility HC Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241767
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