510(k) · Cleared
ClearedMpact 3D Metal Augments II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 23, 2025 as substantially equivalent to K171966 (Medacta International S.A., 2018) after a 267-day review. Its family tree reaches back 13 generations to 1994.
- Decided
- Apr 23, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K941847 (1994). 158 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 backK132879 Mpact ExtensionMedacta International · 2014
- 1 generation backK171966 Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A. · 2018
- This deviceK242232 Mpact 3D Metal Augments IIMedacta 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 backK132879 Mpact ExtensionMedacta International · 2014
- 1 generation backK171966 Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A. · 2018
- This deviceK242232 Mpact 3D Metal Augments IIMedacta 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 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| −1 | K171966 | Mpact® 3D Metal™ Implants and Augments 3D Metal™ | Medacta International S.A. | 2018 | — |
| 0 (this device) | K242232 | Mpact 3D Metal Augments II | 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 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 14 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K171966 | Mpact® 3D Metal™ Implants and Augments 3D Metal™Summary page 5…II III. Predicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • Augments 3D Metal™, K171966, Medacta International S.A. Reference predicate devices: • 3DMetal Tibial Cones, K170149, Medacta Internationa… | 2018 |
| † | K170149 | 3DMetal Tibial Cones | 2017 |
| † | K221850 | GMK 3D Metal Tibial Tray | 2022 |
| † | K170690 | M-Vizion Femoral Revision System | 2017 |
| † | K170910 | Medacta Anatomic Shoulder Prosthesis | 2017 |
| † | K170452 | Medacta Shoulder System | 2017 |
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.
- 46 of the 157 ancestors have a recall of any class.
- 1 other device also cites its predicate K171966.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.
Mpact 3D Metal Augments are indicated in cases of:
• Acetabular dysplasia;
• Acetabular fractures;
• Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242232: Mpact 3D Metal Augments II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242232
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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