510(k) · Cleared
ClearedMpact Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 28, 2012 as substantially equivalent to K103721 (Medacta International, 2011) and 1 other predicate after a 30-day review. Its family tree reaches back 10 generations to 1994. 14 later devices descend from it.
- Decided
- Sep 28, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K941847 (1994). 141 ancestors in all, the oldest K840643 (1984). 14 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 6 generations between
- 3 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 2 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 1 generation backK103721 Mpact Acetabular SystemMedacta International · 2011
- This deviceK122641 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
- Descendant · cites it directly · 3 of its ownK131458 Mpact DM Liner ConverterMedacta International · 2013
Show all 10 generations
- Root · 10 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 9 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 8 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 7 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 6 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 5 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 4 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 3 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 2 generations backK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- 1 generation backK103721 Mpact Acetabular SystemMedacta International · 2011
- This deviceK122641 Mpact ExtensionMedacta International · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- 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
- K131458Mpact DM Liner ConverterMedacta International · 2013 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −9 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −8 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −7 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −5 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −4 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −3 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −2 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| −1 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
| 0 (this device) | 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 | — |
| +1 | K131458 | Mpact DM Liner Converter | Medacta International | 2013 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 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 1…Code: LPH 21 CFR 888.3353 - Hip joint metalI/ce ramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Device Product Code: LZO Predicate Devices: K1 03721 Mpact Acetabular System, Medacta International K033338 Pinnacle Revision System, Depuy Orthopaedics Mpact Ex… | 2011 |
| * | K033338 | Pinnacle Revision SystemSummary page 1…ined cemented or nonporous uncemented prosthesis Device Product Code: LZO Predicate Devices: K1 03721 Mpact Acetabular System, Medacta International K033338 Pinnacle Revision System, Depuy Orthopaedics Mpact Extension 510(k) Section 5 - Page… | 2004 |
What descends from it? (14)
See all 147 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 41 of the 140 ancestors have a recall of any class.
- Of its descendants, K132879 (Medacta International, 2014) has gone furthest, with 11 descendants of its own.
- 15 other devices also cite its predicate K103721.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The hip prosthesis is 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, posttraumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis. * Avascular necrosis of the femoral head. * Acute traumatic…
Read the full statement (99 words)
The hip prosthesis is 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, posttraumatic 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 as stated in the FDA summary.
https://510kreport.com/device/K122641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122641: Mpact Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122641
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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