510(k) Report

510(k) · Cleared

Cleared

Amistem and Quadra - Line Extension

K121011510(k) SpecialCleared Jun 8, 201266-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medacta International · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Jun 8, 2012 as substantially equivalent to K072857 (Medacta International S.A., 2008) and 2 other predicates after a 66-day review. Its family tree reaches back 5 generations to 1994. 10 later devices descend from it.

Decided
Jun 8, 2012
Review
66 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K932481 (1994). 8 ancestors in all. 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2007: 1 other ancestor2005: 1 other ancestor2025: 2 descendants cleared2018: 2 descendants cleared2019: 1 descendant cleared2020: 3 descendants cleared2021: 1 descendant cleared2022: 1 descendant clearedK932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 1994K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 2000K021178 · SL-Plus Lateralized Stem · Plus Orthopedics · 2002K072857 · Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot · Medacta International S.A. · 2008 · recalledK082792 · Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems · Medacta International S.A. · 2008 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants K082792 · Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems · Medacta International S.A. · 2008 · recalledK072857 · Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot · Medacta International S.A. · 2008 · recalledK021178 · SL-Plus Lateralized Stem · Plus Orthopedics · 2002K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 2000K932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 1994−50
  1. Root · 5 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
  2. 4 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
  3. 3 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
  4. 2 generations backK072857 Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head +…Medacta International S.A. · 2008 · Recalled
  5. 1 generation backK082792 Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsMedacta International S.A. · 2008 · Recalled
  6. This deviceK121011 Amistem and Quadra - Line ExtensionMedacta International · 2012
  7. Descendant · cites it directly · 9 of its ownK173794 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A. · 2018
  8. Descendant · 2 generations on · 7 of its ownK181254 Quadra PMedacta International S.A. · 2018
  9. Descendant · 3 generations on · 6 of its ownK192827 Quadra-PMedacta International S.A. · 2020
  10. Descendant · 3 generations on · 1 of its ownK202730 Quadra-PMedacta International S.A. · 2020
  11. Descendant · 4 generations on · 1 of its ownK203041 SMS Cementless StemMedacta International S.A. · 2020

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2018: 22019: 12020: 32021: 12022: 12025: 2
2018high 3 (2020) · low 0 (2023)2026

Most influential descendants

Showing 5 of 10 · See all
  • 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
  • K202730Quadra-PMedacta International S.A. · 2020 · 3 generations on1descendant
  • K203041SMS Cementless StemMedacta International S.A. · 2020 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K932481SL-Plus and SLR-PlusEncore Orthopedics, Inc.1994—
−4K001942SL-Plus and SLR-Plus StemsPlus Orthopedics2000—
−3K021178SL-Plus Lateralized StemPlus Orthopedics2002—
−2K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotMedacta International S.A.20081
−1K082792Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsMedacta International S.A.20081
0 (this device)K121011Amistem and Quadra - Line ExtensionMedacta International2012—
+1K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.2018—
+2K181254Quadra PMedacta International S.A.2018—
+3K192827Quadra-PMedacta International S.A.2020—
+3K202730Quadra-PMedacta International S.A.2020—
+4K203041SMS Cementless StemMedacta International S.A.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201820
201910
202030
202110
202210
202520
FIG. 1 — Lineage of K121011, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot
Summary page 1
…21 CFR 888.3353 Class 11 Device Product Codes: LZO, MEH Predicate Devices: K072857 - Medacta Total Hip Prosthesis System- Quadra S, CoCr Ball Heads, Medacta International…
Medacta International S.A.20081
*K082792Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems
Summary page 1
…LZO, MEH Predicate Devices: K072857 - Medacta Total Hip Prosthesis System- Quadra S, CoCr Ball Heads, Medacta International K082792 - Quadra H; Quadra R, Medacta International K093944 - AMIStem H; Quadra S-H (SN), Medacta International AM…
Medacta International S.A.20081
*K093944Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S
Summary page 1
…ystem- Quadra S, CoCr Ball Heads, Medacta International K082792 - Quadra H; Quadra R, Medacta International K093944 - AMIStem H; Quadra S-H (SN), Medacta International AMIStem and Quadra - Line Extension 510(k) Section 5…
Medacta International S.A.20101

Also cleared against K072857: 5 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189
K250450Coated hip implantsMedacta International S.A.20250

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 4 companies; a new generation was cleared every 3.4 years on median.
  • 3 of the 8 ancestors have a recall of any class.
  • Of its descendants, K173794 (Medacta International S.A., 2018) has gone furthest, with 9 descendants of its own.
  • 5 other devices also cite its predicate K072857.

How does its category compare?

All LZO devices

LZO 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

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

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/or 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 arthroplasty, or total hip replacement.

Indications for use as stated in the FDA summary.

Also cleared against K072857

5 other devices cite the same predicate.

  • K111145Endo HeadMedacta International · 2011
  • K093944Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A. · 20101 recall
  • K083558Medacta Total Hip Prosthesis System - Quadra CMedacta International S.A. · 20091 recall
  • K082792Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsMedacta International S.A. · 20081 recall
  • K080885Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A. · 2008

More from Medacta International

39 FDA decisions under this applicant name. See the company

  • K160605MectaLIF Anterior Stand-AloneMedacta International · 2016
  • K160289MasterLoc StemMedacta International · 2016
  • K153664M.U.S.T. Pedicle Screw SystemMedacta International · 2016
  • K151531MasterLoc StemMedacta International · 2015
  • K142744Mecta-C TiPEEKMedacta International · 2015

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K121011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121011: Amistem and Quadra - Line Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121011

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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