510(k) Report

510(k) · Cleared

Cleared

Corail

K953111510(k) TraditionalCleared Dec 27, 1996543-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

Landos, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Dec 27, 1996 after a 543-day review. The FDA summary names no predicate by number. 251 later devices descend from it.

Decided
Dec 27, 1996
Review
543 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

251 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2016: 9 descendants cleared2011: 11 descendants cleared2005: 1 descendant cleared2013: 18 descendants cleared2017: 13 descendants cleared2012: 11 descendants cleared2004: 1 descendant cleared2002: 1 descendant cleared2019: 19 descendants cleared2008: 6 descendants cleared2007: 1 descendant cleared2023: 20 descendants cleared2010: 5 descendants cleared2022: 16 descendants cleared2018: 17 descendants cleared2020: 19 descendants cleared2021: 13 descendants cleared2006: 2 descendants cleared2024: 18 descendants cleared2026: 14 descendants cleared2014: 6 descendants cleared2025: 19 descendants cleared2015: 8 descendants cleared2009: 3 descendants cleared1995200020052010201520202025
  1. This deviceK953111 CorailLandos, Inc. · 1996
  2. Descendant · cites it directly · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled
  3. Descendant · cites it directly · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
  4. Descendant · 2 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
  5. Descendant · 3 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  6. Descendant · 2 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006

Showing 5 of 251 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 12006: 22007: 12008: 62009: 32010: 52011: 112012: 112013: 182014: 62015: 82016: 92017: 132018: 172019: 192020: 192021: 132022: 162023: 202024: 182025: 192026: 14
2002high 20 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 251 · See all
  • K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · cites it directly168descendants
  • K043079Bicontact Hip System with U-CapAesculap · 2004 · cites it directly166descendants
  • K093472Trinity Acetabular SystemCorin USA · 2010 · 2 generations on117descendants
  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 3 generations on109descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 2 generations on90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953111CorailLandos, Inc.1996—
+1K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051
+1K043079Bicontact Hip System with U-CapAesculap2004—
+2K093472Trinity Acetabular SystemCorin USA20101
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
+2K060437Excia Total Hip System with U-CapAesculap, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200510
200620
200710
200860
200930
201050
2011110
2012110
2013180
201460
201580
201690
2017130
2018170
2019190
2020190
2021130
2022160
2023200
2024180
2025190
2026140
FIG. 1 — Lineage of K953111, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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?

The FDA summary names no predicate by number.

What descends from it? (251)

See all 251

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

NumberDeviceApplicantDecidedDescendants
K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.2005168
K043079Bicontact Hip System with U-CapAesculap2004166
K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp.201122
K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.201220
K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc.201311
K111910Gladiator Hip StemWrightmedicaltechnologyinc20115
K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114
K171249Entrada™ hip stemOrtho Development Corporation20172
K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.20161
K021108Esop HA Femoral StemFournitures Hospitalieres20020

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?

  • Of its descendants, K042992 (DePuy Orthopaedics, Inc., 2005) has gone furthest, with 168 descendants of its own.

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.

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—

More from Landos, Inc.

15 FDA decisions under this applicant name. See the company

  • K964226Memory Staple (20 Sizes Available)Landos, Inc. · 1997
  • K97106834MM Scarf Thread-Head (TM) ScrewLandos, Inc. · 1997
  • K971069Twist-Off (TM) ScrewLandos, Inc. · 1997
  • K971070Scarf Thread-Head (TM) Head ScrewLandos, Inc. · 1997
  • K961732KARLandos, Inc. · 1997

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/K953111 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953111: Corail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953111

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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