510(k) · Cleared
ClearedMfinity Femoral 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 Jun 13, 2025 as substantially equivalent to K210581 (Depuy Ireland UC, 2021) and 5 other predicates after a 59-day review. Its family tree reaches back 17 generations to 1994.
- Decided
- Jun 13, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 17 generations to K941847 (1994). 228 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 13 generations between
- 3 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 2 generations backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- 1 generation backK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- This deviceK251166 Mfinity Femoral SystemMedacta International S.A. · 2025
Show all 17 generations
- Root · 17 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 16 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 15 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 14 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 13 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 12 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 11 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 10 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 9 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 8 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 7 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 6 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 5 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 4 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 3 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 2 generations backK160907 DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland) · 2016
- 1 generation backK210581 Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC · 2021
- This deviceK251166 Mfinity Femoral SystemMedacta International S.A. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −16 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −15 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −14 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −13 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −12 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −11 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −10 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −9 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −8 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −7 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −6 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −5 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −4 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −3 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −2 | K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy (Ireland) | 2016 | — |
| −1 | K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021 | — |
| 0 (this device) | K251166 | Mfinity Femoral System | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 14 | 0 |
| 1996 | 15 | 0 |
| 1997 | 8 | 0 |
| 1998 | 9 | 0 |
| 1999 | 9 | 0 |
| 2000 | 25 | 0 |
| 2001 | 13 | 0 |
| 2002 | 13 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 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 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? (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 |
|---|---|---|---|
| * | K210581 | Actis DuoFix Hip Prosthesis- CollarlessSummary page 5…Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: Actis DuoFix Hip Prosthesis- Collarless, K210581, DePuy Ireland UC Additional Predicate devices: DePuy Actis DuoFix Hip Prosthesis, K160907, DEPUY ORTHOPAEDIC… | 2021 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 5…device: Actis DuoFix Hip Prosthesis- Collarless, K210581, DePuy Ireland UC Additional Predicate devices: DePuy Actis DuoFix Hip Prosthesis, K160907, DEPUY ORTHOPAEDICS, INC DePuy Actis Duofox Hip Prosthesis, K150862, DEPUY ORTHOPAEDICS, INC Quadra-P, K1… | 2016 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 5…d UC Additional Predicate devices: DePuy Actis DuoFix Hip Prosthesis, K160907, DEPUY ORTHOPAEDICS, INC DePuy Actis Duofox Hip Prosthesis, K150862, DEPUY ORTHOPAEDICS, INC Quadra-P, K192827, Medacta International SA Quadra-P, K181254, Medacta Internati… | 2015 |
| * | K192827 | Quadra-PSummary page 5…DePuy Actis DuoFix Hip Prosthesis, K160907, DEPUY ORTHOPAEDICS, INC DePuy Actis Duofox Hip Prosthesis, K150862, DEPUY ORTHOPAEDICS, INC Quadra-P, K192827, Medacta International SA Quadra-P, K181254, Medacta International SA AMIStem-P, K173794, Medacta Interna… | 2020 |
| * | K181254 | Quadra PSummary page 5…AEDICS, INC DePuy Actis Duofox Hip Prosthesis, K150862, DEPUY ORTHOPAEDICS, INC Quadra-P, K192827, Medacta International SA Quadra-P, K181254, Medacta International SA AMIStem-P, K173794, Medacta International SA Reference devices: Masterlo… | 2018 |
| * | K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredSummary page 5…, K150862, DEPUY ORTHOPAEDICS, INC Quadra-P, K192827, Medacta International SA Quadra-P, K181254, Medacta International SA AMIStem-P, K173794, Medacta International SA Reference devices: Masterloc, K151531, Medacta International SA GMK Spher… | 2018 |
| † | K151531 | MasterLoc Stem | 2015 |
| † | K223548 | GMK Sphere & GMK SpheriKA Cementless | 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 10 companies; a new generation was cleared every 1.6 years on median.
- 58 of the 227 ancestors have a recall of any class.
- 5 other devices also cite its predicate K210581.
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. 2025, 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?
Mfinity femoral stems are indicated in patients requiring hip arthroplasty. Hip Arthroplasty Total or partial hip arthroplasty is indicated in the following cases: • Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia. • Avascular necrosis of the femoral head. • Acute fracture of the femoral head. • Acute fracture of the proximal femur, suitable to be treated by means of…
Read the full statement (123 words)
Mfinity femoral stems are indicated in patients requiring hip arthroplasty.
Hip Arthroplasty
Total or partial hip arthroplasty is indicated in the following cases:
• Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute fracture of the femoral head.
• Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty.
• Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
• Failure of previous hip surgery:
o Conservative hip surgery.
o Internal fixation.
o Arthrodesis.
o Partial or total hip arthroplasty.
o Hip resurfacing replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251166: Mfinity Femoral System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251166
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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