510(k) · Cleared
ClearedMpres Neck Preserving Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 22, 2021 as substantially equivalent to K083312 (Corin USA, 2010) after a 233-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Sep 22, 2021
- Review
- 233 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K955033 (1996). 83 ancestors in all, the oldest K840643 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 5 generations between
- 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 1 generation backK083312 Minihip StemCorin USA · 2010
- This deviceK210263 Mpres Neck Preserving StemMedacta International S.A. · 2021
- Descendant · cites it directly · 0 of its ownK250450 Coated hip implantsMedacta International S.A. · 2025
Show all 9 generations
- Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 8 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 7 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 6 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 5 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 4 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 1 generation backK083312 Minihip StemCorin USA · 2010
- This deviceK210263 Mpres Neck Preserving StemMedacta International S.A. · 2021
Most influential descendants
Showing 1 of 1 · See all- K250450Coated hip implantsMedacta International S.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −8 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −7 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −6 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −5 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −4 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −3 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −2 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| −1 | K083312 | Minihip Stem | Corin USA | 2010 | — |
| 0 (this device) | K210263 | Mpres Neck Preserving Stem | Medacta International S.A. | 2021 | — |
| +1 | K250450 | Coated hip implants | Medacta International S.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 9 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K083312 | Minihip StemSummary page 4…21 CFR 888.3353 Device Classification II III. Predicate Device Substantial equivalence is claimed to the following primary predicate device: MiniHip, K083312, Corin USA In addition the following reference devices are cited within the submission: MiniHip, K111046, Corin USA … | 2010 |
| † | K111046 | Corin Minihip Femoral Stem | 2011 |
| † | K201673 | SMS Cementless Stem | 2020 |
| † | K181693 | SMS Femoral Stem | 2018 |
| † | K170845 | MiniMAX | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250450 | Coated hip implants | 2025 | 0 |
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 25 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 23 of the 82 ancestors have a recall of any class.
- Of its descendants, K250450 (Medacta International S.A., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K083312.
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. 2021, 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 Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery. Total Hip Arthroplasty with the Mpres stem 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. * Acute traumatic fracture of the femoral head. »…
Read the full statement (129 words)
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.
Total Hip Arthroplasty with the Mpres stem 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.
* Acute traumatic fracture of the femoral head.
» Failure of previous hip surgery:
o Conservative hip surgery,
o Internal fixation,
o Arthrodesis,
o Hip resurfacing replacement.
Partial hip arthroplasty with the Mpres stem is indicated in the following cases:
* Acute traumatic fracture of the femoral head.
* Avascular necrosis of the femoral head.
* Primary pathology involving the femoral head but with a non-deformed acetabulum.
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/K210263 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210263: Mpres Neck Preserving Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210263
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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