510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Depuy Delta TS Ceramic Femoral Heads

K071830510(k) TraditionalCleared Sep 28, 200787-day reviewClass II21 CFR 888.3353Recalls 1

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 Sep 28, 2007 as substantially equivalent to K011533 (DePuy Orthopaedics, Inc., 2002) and 5 other predicates after an 87-day review. Its family tree reaches back 3 generations to 2002. 14 later devices descend from it. It has been recalled once.

Decided
Sep 28, 2007
Review
87 days
Class
Class II
Product code
LZO
Recalls
1
Predicates
6

Its longest line of descent runs back 3 generations to K011533 (2002). 6 ancestors in all. 14 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 2 other ancestors2008: 1 descendant cleared2024: 2 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2014: 1 descendant cleared2025: 3 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant 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
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 8 descendants3 generations forward: 4 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
  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 deviceK071830 Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2007
  5. Descendant · cites it directly · 7 of its ownK073567 Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH · 2008 · Recalled
  6. Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
  7. Descendant · 2 generations on · 2 of its ownK192416 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral…Zimmer GmbH · 2019
  8. Descendant · 2 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
  9. Descendant · 2 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2008: 12013: 12014: 12018: 12019: 12020: 12021: 12023: 12024: 22025: 32026: 1
2008high 3 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all
  • K073567Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH · 2008 · cites it directly7descendants
  • K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
  • K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH · 2019 · 2 generations on2descendants
  • K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 2 generations on1descendant
  • K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 2 generations on1descendant
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)K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2007—
+1K073567Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH20081
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC2024—
+2K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH2019—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC2025—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200520
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201310
201410
201810
201910
202010
202110
202310
202420
202530
202610
FIG. 1 — Lineage of K071830, 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? (6)

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
*K011533Depuy Femoral Heads
Summary page 1
…prosthesis DEVICE PRODUCT CODE: 87 LZO SUBSTANTIALLY DePuy Femoral Heads, K01 1533 DePuy Ceramic Femoral Heads, K031803 DePu…
DePuy Orthopaedics, Inc.2002—
*K031803Depuy Ceramic Femoral Heads
Summary page 1
…87 LZO SUBSTANTIALLY DePuy Femoral Heads, K01 1533 DePuy Ceramic Femoral Heads, K031803 DePuy Ceramic Heads, K040644 Universal Ta…
DePuy Orthopaedics, Inc.2003—
*K040644Modification to Depuy Ceramic Femoral Head
Summary page 1
…Femoral Heads, K01 1533 DePuy Ceramic Femoral Heads, K031803 DePuy Ceramic Heads, K040644 Universal Taper Delta Femoral Head, K070885…
DePuy Orthopaedics, Inc.2004—
*K070885Universal Taper Delta Femoral Head
Summary page 1
…l Heads, K031803 DePuy Ceramic Heads, K040644 Universal Taper Delta Femoral Head, K070885 V-40TM/C-Taper Adapter Sleeve, K051737 V-…
Howmedica Osteonics Corp.2007—
*K051737Modification to V-40/C-Taper Adapter Sleeve
Summary page 1
…040644 Universal Taper Delta Femoral Head, K070885 V-40TM/C-Taper Adapter Sleeve, K051737 V-40TM BIOLOX® delta Ceramic Femoral Head…
Howmedica Osteonics Corp.2005—
*K052718V40 Biolox Delta Ceramic Femoral Heads
Summary page 1
…-40TM/C-Taper Adapter Sleeve, K051737 V-40TM BIOLOX® delta Ceramic Femoral Heads, K052718 11 DEVICE DESCRIPT…
Howmedica Osteonics Corp.20052

Also cleared against K011533: 3 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K073567Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH20087
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 7, 2014Class IIZ-0825-2015Mixed-up of materials/componentsTwo complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K073567 (Zimmer GmbH, 2008) has gone furthest, with 7 descendants of its own.
  • 3 other devices also cite its predicate K011533.

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. 2007, 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 DePuy Delta TS Ceramic Hip Head Prosthesis 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…

Read the full statement (125 words)

The DePuy Delta TS Ceramic Hip Head Prosthesis 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 K011533

3 other devices cite the same predicate.

  • K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional…Depuy Ireland UC · 2024
  • K223745Novae® Dual Mobility System, Hype® Hip SystemSerf · 2023
  • K031803Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003

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/K071830 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071830: Depuy Delta TS Ceramic Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071830

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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