510(k) · Cleared
ClearedMPACT Extension
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 28, 2021 as substantially equivalent to K103721 (Medacta International, 2011) and 1 other predicate after a 435-day review. Its family tree reaches back 12 generations to 1994.
- Decided
- Apr 28, 2021
- Review
- 435 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K941847 (1994). 143 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations between
- 3 generations backK103721 Mpact Acetabular SystemMedacta International · 2011
- 2 generations backK122641 Mpact ExtensionMedacta International · 2012
- 1 generation backK132879 Mpact ExtensionMedacta International · 2014
- This deviceK200391 MPACT ExtensionMedacta International S.A. · 2021
Show all 12 generations
- Root · 12 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 11 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 10 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 9 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 8 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 7 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 6 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 5 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 4 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 3 generations backK103721 Mpact Acetabular SystemMedacta International · 2011
- 2 generations backK122641 Mpact ExtensionMedacta International · 2012
- 1 generation backK132879 Mpact ExtensionMedacta International · 2014
- This deviceK200391 MPACT ExtensionMedacta International S.A. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −11 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −10 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −9 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −8 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −7 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −6 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −5 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −4 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| −3 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| −2 | K122641 | Mpact Extension | Medacta International | 2012 | — |
| −1 | K132879 | Mpact Extension | Medacta International | 2014 | — |
| 0 (this device) | K200391 | MPACT Extension | Medacta International S.A. | 2021 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K103721 | Mpact Acetabular SystemSummary page 5…ification II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary predicate device * Medacta Intemational SA, MPACT, K103721 Additional predicate device * Medacta International SA, MPACT Extension, K132879 IV. Device Description The MPACT Extens… | 2011 |
| * | K132879 | Mpact ExtensionSummary page 5…he following devices: Primary predicate device * Medacta Intemational SA, MPACT, K103721 Additional predicate device * Medacta International SA, MPACT Extension, K132879 IV. Device Description The MPACT Extension implants subject of this submission are twelve (12) sizes of Cancellous Bone Scre… | 2014 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 41 of the 142 ancestors have a recall of any class.
- 15 other devices also cite its predicate K103721.
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. 2021, 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 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…
Read the full statement (360 words)
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.
The Mpact 3D Metal 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.
The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.
The Augments 3D Metal are indicated in cases of:
* Congenital dysplasia.
* Acetabular fractures.
* Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.
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.
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/K200391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200391: MPACT Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200391
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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