510(k) Report

510(k) · Cleared

Cleared

Modification: to Depuy Delta Ceramic Femoral Head

K062748510(k) SpecialCleared Nov 30, 200677-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

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

Cleared on Nov 30, 2006 as substantially equivalent to K031803 (DePuy Orthopaedics, Inc., 2003) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 2002. 219 later devices descend from it.

Decided
Nov 30, 2006
Review
77 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K011533 (2002). 219 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2012: 8 descendants cleared2008: 2 descendants cleared2024: 14 descendants cleared2025: 19 descendants cleared2013: 18 descendants cleared2016: 12 descendants cleared2019: 17 descendants cleared2009: 3 descendants cleared2011: 10 descendants cleared2017: 14 descendants cleared2010: 3 descendants cleared2015: 10 descendants cleared2020: 15 descendants cleared2018: 13 descendants cleared2022: 14 descendants cleared2014: 10 descendants cleared2021: 10 descendants cleared2026: 12 descendants cleared2023: 14 descendants clearedK011533 · Depuy Femoral Heads · DePuy Orthopaedics, Inc. · 2002K031803 · Depuy Ceramic Femoral Heads · DePuy Orthopaedics, Inc. · 2003K040644 · Modification to Depuy Ceramic Femoral Head · DePuy Orthopaedics, Inc. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 20 descendants3 generations forward: 49 descendants4 generations forward: 47 descendants5 generations forward: 37 descendants6 generations forward: 18 descendants7 generations forward: 20 descendants8 generations forward: 17 descendants9 generations forward: 2 descendants10 generations forward: 2 descendants11 generations forward: 3 descendants K040644 · Modification to Depuy Ceramic Femoral Head · DePuy Orthopaedics, Inc. · 2004K031803 · Depuy Ceramic Femoral Heads · DePuy Orthopaedics, Inc. · 2003K011533 · Depuy Femoral Heads · DePuy Orthopaedics, Inc. · 20020+5+10
  1. Root · 3 generations backK011533 Depuy Femoral HeadsDePuy Orthopaedics, Inc. · 2002
  2. 2 generations backK031803 Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003
  3. 1 generation backK040644 Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2004
  4. This deviceK062748 Modification: to Depuy Delta Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2006
  5. Descendant · cites it directly · 217 of its ownK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  6. Descendant · cites it directly · 165 of its ownK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  7. Descendant · 2 generations on · 149 of its ownK083762 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009
  8. Descendant · 2 generations on · 140 of its ownK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  9. Descendant · 3 generations on · 110 of its ownK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011

Showing 5 of 219 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 32010: 32011: 102012: 82013: 182014: 102015: 102016: 122017: 142018: 132019: 172020: 152021: 102022: 142023: 142024: 142025: 192026: 12
2007high 19 (2025) · low 1 (2007)2026

Most influential descendants

Showing 5 of 219 · See all
  • K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · cites it directly217descendants
  • K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P. · 2008 · cites it directly165descendants
  • K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2009 · 2 generations on149descendants
  • K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010 · 2 generations on140descendants
  • K103120Corin Biolox Delta Femoral HeadsCorin USA · 2011 · 3 generations on110descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K011533Depuy Femoral HeadsDePuy Orthopaedics, Inc.2002—
−2K031803Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2003—
−1K040644Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc.2004—
0 (this device)K062748Modification: to Depuy Delta Ceramic Femoral HeadDePuy Orthopaedics, Inc.2006—
+1K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
+1K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
+2K083762Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2009—
+2K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
+3K103120Corin Biolox Delta Femoral HeadsCorin USA2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200930
201030
2011100
201280
2013180
2014100
2015100
2016120
2017140
2018130
2019170
2020150
2021100
2022140
2023140
2024140
2025190
2026120
FIG. 1 — Lineage of K062748, 2002–2026Source: 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? (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
*K031803Depuy Ceramic Femoral Heads
Summary page 1
…ed prosthesis; DEVICE PRODUCT CODE: 87 LZO SUBSTANTIALLY EQUIVALENT DEVICE: DePuy Ceramic Femoral Heads, K031803 DePuy Ceramic Heads, K040644 DEVICE DESCRIPTION: The DePuy Delta Ceramic Femoral…
DePuy Orthopaedics, Inc.2003—
*K040644Modification to Depuy Ceramic Femoral Head
Summary page 1
…ANTIALLY EQUIVALENT DEVICE: DePuy Ceramic Femoral Heads, K031803 DePuy Ceramic Heads, K040644 DEVICE DESCRIPTION: The DePuy Delta Ceramic Femoral Head is composed of an alumina composite material and is available in a 36m…
DePuy Orthopaedics, Inc.2004—

Also cleared against K031803: 8 other devices →

What descends from it? (219)

See all 219

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

NumberDeviceApplicantDecidedDescendants
K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.2007217
K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.2008165
K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd.20128
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245

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 4 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K071535 (Zimmer, Inc., 2007) has gone furthest, with 217 descendants of its own.
  • 8 other devices also cite its predicate K031803.

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—

What is it indicated for?

The DePuy Delta Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or…

Read the full statement (123 words)

The DePuy Delta Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures.

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.

2. Avascular necrosis of the femoral head.

3. Acute traumatic fracture of the femoral head or neck.

4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

5. Certain cases of ankylosis.

Indications for use as stated in the FDA summary.

Also cleared against K031803

8 other devices cite the same predicate.

  • K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional…Depuy Ireland UC · 2024
  • K222296ARTICUL/EZE Ceramic HeadsDepuy Ireland UC · 2023
  • K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015
  • K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 20071 recall
  • K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
  • K042091Biolox Delta Ceramic HeadsBiomet, Inc. · 20052 recalls

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

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/K062748 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062748: Modification: to Depuy Delta Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062748

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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