510(k) · Cleared
ClearedMpact 3D Metal Foam
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 Aug 28, 2026 as substantially equivalent to K050937 (Zimmer Trabecular, 2005) and 6 other predicates after a 282-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Aug 28, 2026
- Review
- 282 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K941847 (1994). 223 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 deviceK253630 Mpact 3D Metal FoamMedacta International S.A. · 2026
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 deviceK253630 Mpact 3D Metal FoamMedacta International S.A. · 2026
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) | K253630 | Mpact 3D Metal Foam | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 20 | 0 |
| 1995 | 14 | 0 |
| 1996 | 16 | 0 |
| 1997 | 11 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 17 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 11 | 0 |
| 2004 | 5 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 13 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 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 24.3 · 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? (7)
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 |
|---|---|---|---|
| * | K050937 | Trabecular Metal Acetabular Revision ShellsSummary page 5…edicate Device Substantial equivalence is claimed to the following predicate devices. Primary Predicate device: • Trabecular metal acetabular revision shells, K050937, Zimmer Trabecular Additional Predicate devices: • Trabecular metal acetabular revision system cage, K061226, Z… | 2005 |
| * | K061226 | Trabecular Metal Acetabular Revision System CageSummary page 5…abecular metal acetabular revision shells, K050937, Zimmer Trabecular Additional Predicate devices: • Trabecular metal acetabular revision system cage, K061226, Zimmer Trabecular • Trabecular metal revision shell liners, K051516, Zimmer Trabecular • REDAPT Porous Aceta… | 2006 |
| * | K051516 | Trabecular Metal Revision Shell LinersSummary page 5…dditional Predicate devices: • Trabecular metal acetabular revision system cage, K061226, Zimmer Trabecular • Trabecular metal revision shell liners, K051516, Zimmer Trabecular • REDAPT Porous Acetabular Shell and Cemented Liner, K150790, SMITH & NEPHEW, INC.… | 2005 |
| * | K150790 | REDAPT Porous Acetabular Shell and Cemented LinerSummary page 5…K061226, Zimmer Trabecular • Trabecular metal revision shell liners, K051516, Zimmer Trabecular • REDAPT Porous Acetabular Shell and Cemented Liner, K150790, SMITH & NEPHEW, INC. • Mpact Extension, K230011, Medacta International SA • Mpact acetabular s… | 2015 |
| * | K230011 | Mpact ExtensionSummary page 5…iners, K051516, Zimmer Trabecular • REDAPT Porous Acetabular Shell and Cemented Liner, K150790, SMITH & NEPHEW, INC. • Mpact Extension, K230011, Medacta International SA • Mpact acetabular system, K103721, Medacta International SA • Mpact extension, K12… | 2023 |
| * | K103721 | Mpact Acetabular SystemSummary page 5…Shell and Cemented Liner, K150790, SMITH & NEPHEW, INC. • Mpact Extension, K230011, Medacta International SA • Mpact acetabular system, K103721, Medacta International SA • Mpact extension, K122641, Medacta International SA Reference devices: • Mp… | 2011 |
| * | K122641 | Mpact ExtensionSummary page 5…INC. • Mpact Extension, K230011, Medacta International SA • Mpact acetabular system, K103721, Medacta International SA • Mpact extension, K122641, Medacta International SA Reference devices: • Mpact 3D Metal Implants– DMLS Technology, K202568, Medacta Intern… | 2012 |
| † | K202568 | Mpact® 3D Metal Implants - DMLS Technology | 2021 |
| † | K221850 | GMK 3D Metal Tibial Tray | 2022 |
| † | K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | 2017 |
| † | K170910 | Medacta Anatomic Shoulder Prosthesis | 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 32 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 59 of the 222 ancestors have a recall of any class.
- 1 other device also cites its predicate K050937.
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. 2026, 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 Foam is intended to be used in cementless hip replacement surgeries in combination with Medacta F-Cage and a Medacta cemented cup (Apricot or Versacem), or in combination with a Medacta cemented cup only. Mpact 3D Metal Foam, Medacta F-Cage and Apricot are indicated for use in the case of acetabular bony defect during total hip arthroplasty. Total hip arthroplasty is indicated in the following cases: » Severely painful and/or disabled…
Read the full statement (209 words)
Mpact 3D Metal Foam is intended to be used in cementless hip replacement surgeries in combination with Medacta F-Cage and a Medacta cemented cup (Apricot or Versacem), or in combination with a Medacta cemented cup only. Mpact 3D Metal Foam, Medacta F-Cage and Apricot are indicated for use in the case of acetabular bony defect during total hip arthroplasty.
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 when total hip arthroplasty has been chosen.
* Acute traumatic fracture of the femoral head or neck when total hip arthroplasty has been chosen.
» Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.
When the Mpact 3D Metal Foam is used with the 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/K253630 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253630: Mpact 3D Metal Foam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253630
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026