510(k) Report

510(k) · Cleared

Cleared

Corin Biolox Delta Femoral Heads

K103120510(k) TraditionalCleared Feb 28, 2011129-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

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

Cleared on Feb 28, 2011 as substantially equivalent to K992235 (Corin USA, 1999) and 1 other predicate after a 129-day review. Its family tree reaches back 9 generations to 1981. 110 later devices descend from it.

Decided
Feb 28, 2011
Review
129 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K810258 (1981). 40 ancestors in all. 110 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 2 other ancestors2009: 1 other ancestor2006: 1 other ancestor2005: 2 other ancestors2002: 3 other ancestors2000: 5 other ancestors1998: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2001: 1 other ancestor1994: 4 other ancestors1991: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors2011: 2 descendants cleared2021: 6 descendants cleared2018: 9 descendants cleared2013: 10 descendants cleared2016: 5 descendants cleared2015: 2 descendants cleared2019: 9 descendants cleared2012: 5 descendants cleared2017: 4 descendants cleared2023: 10 descendants cleared2020: 10 descendants cleared2026: 10 descendants cleared2024: 7 descendants cleared2025: 12 descendants cleared2022: 8 descendants cleared2014: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 7 other ancestors4 generations back: 9 other ancestors5 generations back: 3 other ancestors6 generations back: 8 other ancestors7 generations back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 18 descendants3 generations forward: 20 descendants4 generations forward: 13 descendants5 generations forward: 17 descendants6 generations forward: 20 descendants7 generations forward: 7 descendants8 generations forward: 7 descendants9 generations forward: 3 descendants K100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−50+5
  1. Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 5 generations between
  3. 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  4. 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  5. 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  6. This deviceK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
  7. Descendant · cites it directly · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  8. Descendant · 2 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
  9. Descendant · 3 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012
  10. Descendant · 4 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
  11. Descendant · 5 generations on · 38 of its ownK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
Show all 9 generations
  1. Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 3 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 2 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 1 generation backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. This deviceK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011

Showing 5 of 110 descendants. See all descendants

Descendants cleared per year

2011: 22012: 52013: 102014: 12015: 22016: 52017: 42018: 92019: 92020: 102021: 62022: 82023: 102024: 72025: 122026: 10
2011high 12 (2025) · low 1 (2014)2026

Most influential descendants

Showing 5 of 110 · See all
  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · cites it directly109descendants
  • K111911Corin Optimom Modular HeadCorin USA · 2011 · 2 generations on62descendants
  • K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 3 generations on61descendants
  • K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 4 generations on48descendants
  • K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · 5 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−8K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−7K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−6K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−5K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−4K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−3K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−2K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−1K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
0 (this device)K103120Corin Biolox Delta Femoral HeadsCorin USA2011—
+1K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
+2K111911Corin Optimom Modular HeadCorin USA2011—
+3K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA2012—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.20131
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.20151

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199220
199310
199440
199530
199610
199710
199810
199920
200050
200110
200230
200310
200410
200520
200610
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201250
2013100
201410
201520
201650
201740
201890
201990
2020100
202160
202280
2023100
202470
2025120
2026100
FIG. 1 — Lineage of K103120, 1981–2026Source: 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? (2)

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
*K992235Zyranox Zirconia Ceramic Femoral Heads
Summary page 1
…prosthesis (21CFR 888.3353) 6. Legally Marketed Devices to \vbich Substantial Equivalence is claimed: * Zyranox Zirconia Ceramic Modular Heads (1K992235) * Smith & Nephew BIOLOX delta Ceramic Femforal H-eads (1(100412) 7. Device Description: BIOLO…
Corin USA1999—
*K100412Biolox Delta Ceramic Femoral Heads
Summary page 1
…is claimed: * Zyranox Zirconia Ceramic Modular Heads (1K992235) * Smith & Nephew BIOLOX delta Ceramic Femforal H-eads (1(100412) 7. Device Description: BIOLOX delta material is an aluminum oxide / zirconia ceramic composite composed of appr…
Smith & Nephew, Inc.2010—

Also cleared against K992235: 2 other devices →

What descends from it? (110)

See all 110

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

NumberDeviceApplicantDecidedDescendants
K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011109
K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA201333
K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185
K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183
K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212

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 30 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 11 of the 40 ancestors have a recall of any class.
  • Of its descendants, K110087 (Corin USA, 2011) has gone furthest, with 109 descendants of its own.
  • 2 other devices also cite its predicate K992235.

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. 2011, 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 Corin BIOLOX delta Modular Femoral Heads are used in combination with femoral hip stems and ultra high molecular weight polyethylene (UHI-IMWPE) acetabular cup liners to reinstate function following the degenerative effects of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

Rheumatoid arthritis

Correction of functional deformity and

Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)

The Corin I3IOLOX delta Modular Femoral Heads are intended for single use only.

Indications for use as stated in the FDA summary.

Also cleared against K992235

2 other devices cite the same predicate.

  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  • K093472Trinity Acetabular SystemCorin USA · 20101 recall

More from Corin USA

70 FDA decisions under this applicant name. See the company

  • K203751OMNIVision systemCorin USA · 2021
  • K202805Optimized Positioning System (OPS) InsightCorin USA · 2020
  • K193545Corin Optimized Positioning System (OPS) FemoralCorin USA · 2020
  • P050016/S012Cormet Hip Resurfacing SystemCorin USA · 2020
  • K193042Optimized Positioning System (OPS) ReViewCorin USA · 2020

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/K103120 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103120: Corin Biolox Delta Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103120

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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