510(k) · Cleared
ClearedMpact Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 21, 2011 as substantially equivalent to K071784 (DePuy Orthopaedics, Inc., 2007) and 7 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1994. 21 later devices descend from it.
- Decided
- Mar 21, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 9 generations to K941847 (1994). 140 ancestors in all, the oldest K840643 (1984). 21 later devices descend from it, 16 citing it directly.
- Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations between
- 3 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 2 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 1 generation backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- This deviceK103721 Mpact Acetabular SystemMedacta International · 2011
- Descendant · cites it directly · 14 of its ownK122641 Mpact ExtensionMedacta International · 2012
- Descendant · cites it directly · 11 of its ownK132879 Mpact ExtensionMedacta International · 2014
- Descendant · cites it directly · 4 of its ownK183582 MPACT ExtensionMedacta International S.A. · 2019
- Descendant · cites it directly · 3 of its ownK230011 Mpact ExtensionMedacta International S.A. · 2023
- Descendant · cites it directly · 3 of its ownK171966 Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A. · 2018
Show all 9 generations
- Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 7 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 6 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 5 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 4 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 3 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 2 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 1 generation backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- This deviceK103721 Mpact Acetabular SystemMedacta International · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K122641Mpact ExtensionMedacta International · 2012 · cites it directly14descendants
- K132879Mpact ExtensionMedacta International · 2014 · cites it directly11descendants
- K183582MPACT ExtensionMedacta International S.A. · 2019 · cites it directly4descendants
- K230011Mpact ExtensionMedacta International S.A. · 2023 · cites it directly3descendants
- K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A. · 2018 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −8 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −7 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −6 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −4 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −3 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −2 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −1 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| 0 (this device) | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| +1 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| +1 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| +1 | K183582 | MPACT Extension | Medacta International S.A. | 2019 | — |
| +1 | K230011 | Mpact Extension | Medacta International S.A. | 2023 | — |
| +1 | K171966 | Mpact® 3D Metal™ Implants and Augments 3D Metal™ | Medacta International S.A. | 2018 | — |
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 | 1 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (8)
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 |
|---|---|---|---|
| * | K071784 | Depuy Pinnacle with Gripton Acetabular CupsSummary page 2…s 11 Mpact® Acetebular System 510O(k) Section 5- Page 1 of 5 1-7 -2 Predicates: K07 1784 DePuy Pinnacle®D with GriptionrM Acetabular Cups K0011534 Pinnacle Acetabular System, DePuy Orthopedics… | 2007 |
| * | K070756 | Smith and Nephew Reflection 3 Acetabular SystemSummary page 2…1-7 -2 Predicates: K07 1784 DePuy Pinnacle®D with GriptionrM Acetabular Cups K0011534 Pinnacle Acetabular System, DePuy Orthopedics K070756 REFLECTION 3 Acetabular System, Smith & Nephew KIO01575 Apex Modular Heads, +10.5 mm offset, Omni Lifesciences… | 2007 |
| * | K091069 | Medacta Bone Screws - Evolis and VersafitSummary page 2…bility, Medlacta International K092265 Versafitcup® Double Mobility HighCross®)UI-MWPE Liners, Medacta International K09 1069 Medacta Bone Screws, Medacta International K072857 Medacta Total Hip Prosthesis, Medacta International… | 2009 |
| * | K083116 | Versafit Cup Double Mobility SystemSummary page 2…+10.5 mm offset, Omni Lifesciences K100555 Apex- LNK Poly Acetabular Liners and Apex Modular Head, 40 min, Omni Lifesciences K083 116 Versafitcup® Double Mobility, Medlacta International K092265 Versafitcup® Double Mobility HighCross®)UI-MWPE… | 2009 |
| * | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersSummary page 2…abular Liners and Apex Modular Head, 40 min, Omni Lifesciences K083 116 Versafitcup® Double Mobility, Medlacta International K092265 Versafitcup® Double Mobility HighCross®)UI-MWPE Liners, Medacta International K09 1069 Meda… | 2010 |
| * | K101575 | Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810… | 2010 |
| * | K100555 | Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKSummary page 2…edics K070756 REFLECTION 3 Acetabular System, Smith & Nephew KIO01575 Apex Modular Heads, +10.5 mm offset, Omni Lifesciences K100555 Apex- LNK Poly Acetabular Liners and Apex Modular Head, 40 min, Omni Lifesciences K083 116 Versafit… | 2010 |
| * | K080885 | Medacta Total Hip Prosthesis System - Line ExtensionSummary page 2…nternational K09 1069 Medacta Bone Screws, Medacta International K072857 Medacta Total Hip Prosthesis, Medacta International K080885 Medacta Total Hip Prosthesis CoCrMo ball heads, Medacta International Product Description: The Mpact® Ace… | 2008 |
What descends from it? (21)
See all 2116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122641 | Mpact Extension | 2012 | 14 |
| K132879 | Mpact Extension | 2014 | 11 |
| K183582 | MPACT Extension | 2019 | 4 |
| K230011 | Mpact Extension | 2023 | 3 |
| K171966 | Mpact® 3D Metal™ Implants and Augments 3D Metal™ | 2018 | 3 |
| K131458 | Mpact DM Liner Converter | 2013 | 3 |
| K120531 | Versafitcup CC Trio-Additional Liners | 2012 | 2 |
| K241461 | Mpact Constrained Liner | 2025 | 1 |
| K202568 | Mpact® 3D Metal Implants - DMLS Technology | 2021 | 1 |
| K143453 | Mpact Double Mobility System | 2015 | 1 |
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 17 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 41 of the 139 ancestors have a recall of any class.
- Of its descendants, K122641 (Medacta International, 2012) has gone furthest, with 14 descendants of its own.
- 6 other devices also cite its predicate K071784.
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. 2011, 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?
The Mpact®E Acetabular System is intended for cementless use in total hip arthroplasty and 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 psoriactic arthritis, congenital hip dysplasia, or ankylosing spondylitis. Avascular necrosis of the femoral head.…
Read the full statement (98 words)
The Mpact®E Acetabular System is intended for cementless use in total hip arthroplasty and 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 psoriactic arthritis, congenital hip dysplasia, or 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/K103721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103721: Mpact Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103721
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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