510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Biolox Option Ceramic Femoral Head System, Model 8777 Series

K073567510(k) TraditionalCleared Mar 13, 200884-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

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

Cleared on Mar 13, 2008 as substantially equivalent to K071830 (DePuy Orthopaedics, Inc., 2007) after an 84-day review. Its family tree reaches back 4 generations to 2002. 7 later devices descend from it. It has been recalled once.

Decided
Mar 13, 2008
Review
84 days
Class
Class II
Product code
LZO
Recalls
1
Predicates
1

Its longest line of descent runs back 4 generations to K011533 (2002). 7 ancestors in all. 7 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 2 other ancestors2018: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared2023: 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. · 2004K071830 · Depuy Delta TS Ceramic Femoral Heads · DePuy Orthopaedics, Inc. · 2007 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants K071830 · Depuy Delta TS Ceramic Femoral Heads · DePuy Orthopaedics, Inc. · 2007 · recalledK040644 · 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 · 4 generations backK011533 Depuy Femoral HeadsDePuy Orthopaedics, Inc. · 2002
  2. 3 generations backK031803 Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2003
  3. 2 generations backK040644 Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc. · 2004
  4. 1 generation backK071830 Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc. · 2007 · Recalled
  5. This deviceK073567 Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH · 2008
  6. Descendant · cites it directly · 2 of its ownK192416 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral…Zimmer GmbH · 2019
  7. Descendant · cites it directly · 1 of its ownK123619 Intrablock Bioball Hip System (Ibs)Merete Medical GmbH · 2013
  8. Descendant · 2 generations on · 0 of its ownK223828 BENCOX Delta Option HeadsCorentec Co., Ltd. · 2023
  9. Descendant · cites it directly · 0 of its ownK201047 Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021
  10. Descendant · 2 generations on · 0 of its ownK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12018: 12019: 12020: 12021: 12023: 1
2013high 1 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 7 · See all
  • K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH · 2019 · cites it directly2descendants
  • K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH · 2013 · cites it directly1descendant
  • K223828BENCOX Delta Option HeadsCorentec Co., Ltd. · 2023 · 2 generations on0descendants
  • K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd. · 2021 · cites it directly0descendants
  • K200112Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011533Depuy Femoral HeadsDePuy Orthopaedics, Inc.2002—
−3K031803Depuy Ceramic Femoral HeadsDePuy Orthopaedics, Inc.2003—
−2K040644Modification to Depuy Ceramic Femoral HeadDePuy Orthopaedics, Inc.2004—
−1K071830Depuy Delta TS Ceramic Femoral HeadsDePuy Orthopaedics, Inc.20071
0 (this device)K073567Biolox Option Ceramic Femoral Head System, Model 8777 SeriesZimmer GmbH2008—
+1K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH2019—
+1K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH2013—
+2K223828BENCOX Delta Option HeadsCorentec Co., Ltd.2023—
+1K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.2021—
+2K200112Zimmer Hip Joint ReplacementZimmer GmbH20202

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200520
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201810
201910
202010
202110
202310
FIG. 1 — Lineage of K073567, 2002–2023Source: 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? (1)

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
*K071830Depuy Delta TS Ceramic Femoral Heads
Summary page 1
…(Taper Sleeve) Ceramic Femoral Head, manufactured by DePuy Orthopaedics, Inc., K07 1830, cleared September 28, 2007 Device Description: The BIOLOX OPTION Ceramic Femoral Head…
DePuy Orthopaedics, Inc.20071

Also cleared against K071830: 1 other device →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192
K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131
K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210
K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180
K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 4, 2012Class IIZ-0212-2013Error in labelingZimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K192416 (Zimmer GmbH, 2019) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K071830.

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. 2008, 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 BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and indicated for the following: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia…

Read the full statement (96 words)

The BIOLOX OPTION Ceramic Femoral Head System is comprised of modular components used in primary or revision total hip arthroplasty and indicated for the following:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion: patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.

Indications for use as stated in the FDA summary.

Also cleared against K071830

1 other device cites the same predicate.

  • K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional…Depuy Ireland UC · 2024

More from Zimmer GmbH

43 FDA decisions under this applicant name. See the company

  • K211047CoCr HeadZimmer GmbH · 2023
  • K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
  • K200112Zimmer Hip Joint ReplacementZimmer GmbH · 20202 recalls
  • K193099Anatomical Shoulder SystemZimmer GmbH · 2020
  • K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbH · 2019

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/K073567 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073567: Biolox Option Ceramic Femoral Head System, Model 8777 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073567

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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