510(k) · Cleared
ClearedCoated hip implants
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 Sep 19, 2025 as substantially equivalent to K103352 (Medacta International, 2011) and 20 other predicates after a 213-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Sep 19, 2025
- Review
- 213 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 21
Its longest line of descent runs back 14 generations to K941847 (1994). 324 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations between
- 3 generations backK132879 Mpact ExtensionMedacta International · 2014
- 2 generations backK183582 MPACT ExtensionMedacta International S.A. · 2019
- 1 generation backK230011 Mpact ExtensionMedacta International S.A. · 2023
- This deviceK250450 Coated hip implantsMedacta International S.A. · 2025
Show all 14 generations
- Root · 14 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 12 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 11 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 10 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 9 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 8 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 7 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 6 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 5 generations backK103721 Mpact Acetabular SystemMedacta International · 2011
- 4 generations backK122641 Mpact ExtensionMedacta International · 2012
- 3 generations backK132879 Mpact ExtensionMedacta International · 2014
- 2 generations backK183582 MPACT ExtensionMedacta International S.A. · 2019
- 1 generation backK230011 Mpact ExtensionMedacta International S.A. · 2023
- This deviceK250450 Coated hip implantsMedacta International S.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −13 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −12 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −11 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −10 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −9 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −8 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −7 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −6 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| −5 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| −4 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| −3 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| −2 | K183582 | MPACT Extension | Medacta International S.A. | 2019 | — |
| −1 | K230011 | Mpact Extension | Medacta International S.A. | 2023 | — |
| 0 (this device) | K250450 | Coated hip implants | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 4 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 8 | 0 |
| 1993 | 5 | 0 |
| 1994 | 24 | 0 |
| 1995 | 18 | 0 |
| 1996 | 25 | 0 |
| 1997 | 14 | 0 |
| 1998 | 13 | 0 |
| 1999 | 14 | 0 |
| 2000 | 27 | 0 |
| 2001 | 14 | 0 |
| 2002 | 18 | 0 |
| 2003 | 14 | 0 |
| 2004 | 8 | 0 |
| 2005 | 13 | 0 |
| 2006 | 9 | 0 |
| 2007 | 14 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 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? (21)
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 7…cate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: Medacta International SA, Versafitcup® CC Trio, K103352; Additional Predicate devices: Medacta International SA, Versafitcup CC Trio extension, K122911; … | 2011 |
| * | K122911 | Versafitcup CC Trio ExtensionSummary page 7… Medacta International SA, Versafitcup® CC Trio, K103352; Additional Predicate devices: Medacta International SA, Versafitcup CC Trio extension, K122911; Medacta International SA, Quadra P, K181254; Medacta International SA, Quadra-P, K192827; Me… | 2012 |
| * | K181254 | Quadra PSummary page 7…3352; Additional Predicate devices: Medacta International SA, Versafitcup CC Trio extension, K122911; Medacta International SA, Quadra P, K181254; Medacta International SA, Quadra-P, K192827; Medacta International SA, Quadra-P, K202730; Me… | 2018 |
| * | K192827 | Quadra-PSummary page 7…edacta International SA, Versafitcup CC Trio extension, K122911; Medacta International SA, Quadra P, K181254; Medacta International SA, Quadra-P, K192827; Medacta International SA, Quadra-P, K202730; Medacta International SA, AMIStem-H Proximal Coating, K1616… | 2020 |
| * | K202730 | Quadra-PSummary page 7…122911; Medacta International SA, Quadra P, K181254; Medacta International SA, Quadra-P, K192827; Medacta International SA, Quadra-P, K202730; Medacta International SA, AMIStem-H Proximal Coating, K161635; Medacta International SA, AMIStem-H Proxi… | 2020 |
| * | K161635 | AMIStem-H Proximal CoatingSummary page 7… Medacta International SA, Quadra-P, K192827; Medacta International SA, Quadra-P, K202730; Medacta International SA, AMIStem-H Proximal Coating, K161635; Medacta International SA, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared, K173794;… | 2017 |
| * | K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredSummary page 7…International SA, AMIStem-H Proximal Coating, K161635; Medacta International SA, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared, K173794; Medacta International SA, AMIStem-P Short Neck, K192126; K250450 P… | 2018 |
| * | K192126 | AMIStem-P Short NeckSummary page 7…edacta International SA, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared, K173794; Medacta International SA, AMIStem-P Short Neck, K192126; K250450 Page 2 of 6 Coated hip implants… | 2019 |
| * | K170845 | MiniMAXSummary page 8…d hip implants Medacta International SA Traditional 510(k) – K250450 Medacta International SA, MiniMAX, K170845; Medacta International SA, MiniMAX, K192352; Medacta International SA, SMS Femoral Stem, K181693; … | 2017 |
| * | K192352 | MiniMAXSummary page 8…Medacta International SA Traditional 510(k) – K250450 Medacta International SA, MiniMAX, K170845; Medacta International SA, MiniMAX, K192352; Medacta International SA, SMS Femoral Stem, K181693; Medacta International SA, SMS Cementless Stem, K20167… | 2019 |
| * | K181693 | SMS Femoral StemSummary page 8…450 Medacta International SA, MiniMAX, K170845; Medacta International SA, MiniMAX, K192352; Medacta International SA, SMS Femoral Stem, K181693; Medacta International SA, SMS Cementless Stem, K201673; Medacta International SA, SMS Cementless Stem, K20… | 2018 |
| * | K201673 | SMS Cementless StemSummary page 8… Medacta International SA, MiniMAX, K192352; Medacta International SA, SMS Femoral Stem, K181693; Medacta International SA, SMS Cementless Stem, K201673; Medacta International SA, SMS Cementless Stem, K203041; Medacta International SA, Mpres Neck Preserving St… | 2020 |
| * | K203041 | SMS Cementless StemSummary page 8…International SA, SMS Femoral Stem, K181693; Medacta International SA, SMS Cementless Stem, K201673; Medacta International SA, SMS Cementless Stem, K203041; Medacta International SA, Mpres Neck Preserving Stem, K210263; Medacta International SA, Medacta Total Hip… | 2020 |
| * | K210263 | Mpres Neck Preserving StemSummary page 8…nal SA, SMS Cementless Stem, K201673; Medacta International SA, SMS Cementless Stem, K203041; Medacta International SA, Mpres Neck Preserving Stem, K210263; Medacta International SA, Medacta Total Hip Prothesis System-AMIStem H, Quadra S And Quadra H femoral stem… | 2021 |
| * | K093944 | Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SSummary page 8…, Mpres Neck Preserving Stem, K210263; Medacta International SA, Medacta Total Hip Prothesis System-AMIStem H, Quadra S And Quadra H femoral stems, K093944; Medacta International SA, AMIStem and Quadra - Line Extension, K121011; Medacta International SA, Medacta… | 2010 |
| * | K121011 | Amistem and Quadra - Line ExtensionSummary page 8…Total Hip Prothesis System-AMIStem H, Quadra S And Quadra H femoral stems, K093944; Medacta International SA, AMIStem and Quadra - Line Extension, K121011; Medacta International SA, Medacta Total Hip Prosthesis System – Quadra J, Quadra R, K082792; Me… | 2012 |
| * | K082792 | Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsSummary page 8…International SA, AMIStem and Quadra - Line Extension, K121011; Medacta International SA, Medacta Total Hip Prosthesis System – Quadra J, Quadra R, K082792; Medacta International SA, Mpact® Acetabular System, K103721; Medacta International SA, Mpact Extension, K1… | 2008 |
| * | K103721 | Mpact Acetabular SystemSummary page 8…Medacta International SA, Medacta Total Hip Prosthesis System – Quadra J, Quadra R, K082792; Medacta International SA, Mpact® Acetabular System, K103721; Medacta International SA, Mpact Extension, K122641; Medacta International SA, Mpact Extension, K132879;… | 2011 |
| * | K122641 | Mpact ExtensionSummary page 8…m – Quadra J, Quadra R, K082792; Medacta International SA, Mpact® Acetabular System, K103721; Medacta International SA, Mpact Extension, K122641; Medacta International SA, Mpact Extension, K132879; Medacta International SA, Mpact Extension, K230011. I… | 2012 |
| * | K132879 | Mpact ExtensionSummary page 8…International SA, Mpact® Acetabular System, K103721; Medacta International SA, Mpact Extension, K122641; Medacta International SA, Mpact Extension, K132879; Medacta International SA, Mpact Extension, K230011. IV. Device Description The aim of this submission is to seek… | 2014 |
| * | K230011 | Mpact ExtensionSummary page 8…Medacta International SA, Mpact Extension, K122641; Medacta International SA, Mpact Extension, K132879; Medacta International SA, Mpact Extension, K230011. IV. Device Description The aim of this submission is to seek clearance for the addition of a new coating supplier for the f… | 2023 |
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 1.8 years on median.
- 90 of the 323 ancestors have a recall of any class.
- 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. 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?
The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are 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 psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis. • Avascular…
Read the full statement (842 words)
The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are 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 psoriatic 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 where sufficient bone stock is present.
The hip prosthesis Quadra-P and Quadra-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The Quadra-P Cemented is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip Replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The MiniMax is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The hip prosthesis Quadra -S, Quadra-H and Quadra-R is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The hip prosthesis Quadra-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The Quadra-C size 0 implant should not be implanted in patients with a mass of 65 kg or greater.
The hip prosthesis SMS and SMS Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases:
• Severely painful and/or disabled joint as a result of arthritis, 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.
Total Hip Arthroplasty with the Mpres stem 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.
• Failure of previous hip surgery:
• Conservative hip surgery,
• Internal fixation,
• Arthrodesis,
• Hip resurfacing replacement.
Partial hip arthroplasty with the Mpres stem is indicated in the following cases:
• Acute traumatic fracture of the femoral head.
• Avascular necrosis of the femoral head.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
The Mpact implants are 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 psoriatic 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 where sufficient bone stock is present.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250450: Coated hip implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250450
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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