510(k) · Cleared
Recalled · Class II · 2012Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S
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 Jan 21, 2010 as substantially equivalent to K072857 (Medacta International S.A., 2008) after a 30-day review. Its family tree reaches back 4 generations to 1994. 12 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2010
- Review
- 30 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K932481 (1994). 6 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 3 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 2 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 1 generation backK072857 Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head +…Medacta International S.A. · 2008 · Recalled
- This deviceK093944 Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A. · 2010
- Descendant · cites it directly · 10 of its ownK161635 AMIStem-H Proximal CoatingMedacta International S.A. · 2017
- Descendant · cites it directly · 10 of its ownK121011 Amistem and Quadra - Line ExtensionMedacta International · 2012
- Descendant · cites it directly · 9 of its ownK173794 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A. · 2018
- Descendant · 2 generations on · 7 of its ownK181254 Quadra PMedacta International S.A. · 2018
- Descendant · 3 generations on · 6 of its ownK192827 Quadra-PMedacta International S.A. · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K161635AMIStem-H Proximal CoatingMedacta International S.A. · 2017 · cites it directly10descendants
- K121011Amistem and Quadra - Line ExtensionMedacta International · 2012 · cites it directly10descendants
- K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A. · 2018 · cites it directly9descendants
- K181254Quadra PMedacta International S.A. · 2018 · 2 generations on7descendants
- K192827Quadra-PMedacta International S.A. · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −3 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −2 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −1 | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | Medacta International S.A. | 2008 | 1 |
| 0 (this device) | K093944 | Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S | Medacta International S.A. | 2010 | — |
| +1 | K161635 | AMIStem-H Proximal Coating | Medacta International S.A. | 2017 | — |
| +1 | K121011 | Amistem and Quadra - Line Extension | Medacta International | 2012 | — |
| +1 | K173794 | AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared | Medacta International S.A. | 2018 | — |
| +2 | K181254 | Quadra P | Medacta International S.A. | 2018 | — |
| +3 | K192827 | Quadra-P | Medacta International S.A. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotSummary page 1…assification: Class II, 21 CFR 888.3353 Pmoduct Code: LZO, MEH Predicate Device: Medacta Total Hip Prosthesis - Quadra S femoral stems, K072857, cleared on February 4, 2008 Product Description: The modifications to the original Medacta Total Hip Prosthesis system are a lin… | 2008 |
| † | K082792 | Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems | 2008 |
What descends from it? (12)
See all 124 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2012 | Class II | Z-0791-2013 | Device Design | The tip of the Quadra Trial Broach size 0, broke during a surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K161635 (Medacta International S.A., 2017) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K072857.
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. 2010, 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 Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
Severely painful and/ar disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
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 arthmoplasty, or total hip replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093944: Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093944
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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