510(k) · Cleared
ClearedEndo Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International · LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Cleared on Aug 16, 2011 as substantially equivalent to K896580 (Richards Medical Co., Inc., 1990) and 4 other predicates after a 116-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Aug 16, 2011
- Review
- 116 days
- Class
- Class II
- Product code
- LZY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K941847 (1994). 145 ancestors in all, the oldest K840643 (1984). No later device cites it as a predicate yet.
- 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 deviceK111145 Endo HeadMedacta International · 2011
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 deviceK111145 Endo HeadMedacta International · 2011
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) | K111145 | Endo Head | Medacta International | 2011 | — |
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 | 3 | 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 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 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 LZY? 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 LZY device
- #1 K231448 TANDEM Hip Systemscore 6.4 · 10 generations · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K896580 | Uni-Polar HeadSummary page 1…21 CER 888.3360 Class 11 Device Product Codes: LZY Predicate Devices: K896580 - Smith & Nephew Unipolar System K062408 - Smith & Nephew Modular Femoral (Hemi) Heads K072… | 1990 |
| * | K062408 | Smith & Nephew Modular Femoral (Hemi) HeadSummary page 1…Class 11 Device Product Codes: LZY Predicate Devices: K896580 - Smith & Nephew Unipolar System K062408 - Smith & Nephew Modular Femoral (Hemi) Heads K072857 - Medacta CoCrMo Femoral Ball Heads, 25 and 32mm… | 2006 |
| * | K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotSummary page 1…oduct Codes: LZY Predicate Devices: K896580 - Smith & Nephew Unipolar System K062408 - Smith & Nephew Modular Femoral (Hemi) Heads K072857 - Medacta CoCrMo Femoral Ball Heads, 25 and 32mm K080885 - Medacta CoCrMo Femoral Ball Heads, 22 and 36mm… | 2008 |
| * | K080885 | Medacta Total Hip Prosthesis System - Line ExtensionSummary page 1…m K062408 - Smith & Nephew Modular Femoral (Hemi) Heads K072857 - Medacta CoCrMo Femoral Ball Heads, 25 and 32mm K080885 - Medacta CoCrMo Femoral Ball Heads, 22 and 36mm K1 03721 - Medacta CoCrMo Femoral Ball Heads, 40mm… | 2008 |
| * | K103721 | Mpact Acetabular SystemSummary page 1…K072857 - Medacta CoCrMo Femoral Ball Heads, 25 and 32mm K080885 - Medacta CoCrMo Femoral Ball Heads, 22 and 36mm K1 03721 - Medacta CoCrMo Femoral Ball Heads, 40mm… | 2011 |
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 17 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 43 of the 144 ancestors have a recall of any class.
- 7 other devices also cite its predicate K896580.
How does its category compare?
All LZY devicesLZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LZY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LZY
Too few LZY 510(k)s in any year since 2007 to give a median.
Recalls per year · LZY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZY
74in 2025
MAUDE reports naming product code LZY, 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 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 0 | — | 1 | 20 |
| 2010 | 0 | — | 0 | 38 |
| 2011 | 1 | — | 0 | 43 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 44 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 97 |
| 2016 | 0 | — | 0 | 76 |
| 2017 | 0 | — | 0 | 72 |
| 2018 | 0 | — | 0 | 67 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 0 | — | 0 | 79 |
| 2021 | 0 | — | 0 | 59 |
| 2022 | 0 | — | 0 | 65 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 1 | 74 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medacta Endo Head is intended for use in combination with Medacta's Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
* Femoral neck and trochanteric fractures of the proximal femur;
* Osteonecrosis of the femoral head;
* Revision procedures where other devices or treatments for these indications have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111145: Endo Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111145
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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