510(k) Report

510(k) · Cleared

Cleared

Biolox Option Ceramic Femoral Head and Metha XL Heads

K090299510(k) SpecialCleared Apr 24, 200977-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

Aesculap Implant Systems · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 24, 2009 as substantially equivalent to K042344 (Aesculap, Inc., 2005) and 7 other predicates after a 77-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.

Decided
Apr 24, 2009
Review
77 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
8

Its longest line of descent runs back 9 generations to K955033 (1996). 113 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 2 other ancestors2007: 1 other ancestor2006: 4 other ancestors2005: 5 other ancestors2003: 7 other ancestors2002: 6 other ancestors2001: 4 other ancestors2004: 2 other ancestors2000: 8 other ancestors1999: 1 other ancestor1998: 6 other ancestors1997: 7 other ancestors1996: 7 other ancestors1995: 12 other ancestors1994: 15 other ancestors1992: 3 other ancestors1991: 4 other ancestors1990: 2 other ancestors1987: 2 other ancestors1984: 1 other ancestor1993: 2 other ancestors1985: 1 other ancestor1981: 1 other ancestor2018: 1 descendant clearedK955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996K983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002×2: 2 generations cleared close together, K040191 (2004), K043079 (2004) K060437 · Excia Total Hip System with U-Cap · Aesculap, Inc. · 2006×2: 2 generations cleared close together, K080584 (2008), K082146 (2008) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 12 other ancestors3 generations back: 24 other ancestors4 generations back: 31 other ancestors5 generations back: 18 other ancestors6 generations back: 9 other ancestors7 generations back: 3 other ancestors 1 generation forward: 1 descendant K082146 · Metha Short Stem Hip System XL Femoral Head · Aesculap Implant Systems, Inc. · 2008K080584 · Metha Short Stem Hip System · Aesculap Implant System, Inc. · 2008K060437 · Excia Total Hip System with U-Cap · Aesculap, Inc. · 2006K043079 · Bicontact Hip System with U-Cap · Aesculap · 2004K040191 · Bicontact Hip Stem and Femoral Head · Aesculap · 2004K022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996−50
  1. Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 5 generations between
  3. 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  4. 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  5. 1 generation backK082146 Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  6. This deviceK090299 Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems · 2009
  7. Descendant · cites it directly · 0 of its ownK172235 CoreHip® SystemAesculap Implants Systems, LLC · 2018
Show all 9 generations
  1. Root · 9 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 8 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
  3. 7 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
  4. 6 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
  5. 5 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  6. 4 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
  7. 3 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  8. 2 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  9. 1 generation backK082146 Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  10. This deviceK090299 Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K172235CoreHip® SystemAesculap Implants Systems, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K955033Rim Flare Acetabular ComponentIntermedics Orthopedics1996—
−8K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc.1999—
−7K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc.20003
−6K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002—
−5K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
−4K043079Bicontact Hip System with U-CapAesculap2004—
−3K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
−2K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—
−1K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.2008—
0 (this device)K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems2009—
+1K172235CoreHip® SystemAesculap Implants Systems, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
198510
198720
199020
199140
199230
199320
1994150
1995120
199670
199770
199860
199910
200080
200140
200260
200370
200420
200550
200640
200710
200820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K090299, 1996–2018Source: 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? (8)

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
*K042344Excia Total Hip System
Summary page 1
…NCE Aesculap Implant Systems, Inc. believes that the BIOLOX® OPTION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aesculap Implant Systems, Inc. BIOLOX delta Cera…
Aesculap, Inc.200510
*K060918Excia Total Hip System 12/14 Trunnion with Ceramic Head
Summary page 1
…lap Implant Systems, Inc. believes that the BIOLOX® OPTION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aesculap Implant Systems, Inc. BIOLOX delta Ceramic Femor…
Aesculap, Inc.2006—
*K062684Excia Total Hip System 36MM Ceramic Head
Summary page 1
…ystems, Inc. believes that the BIOLOX® OPTION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aesculap Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082…
Aesculap, Inc.2006—
*K071916Metha Hip System
Summary page 1
…s that the BIOLOX® OPTION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aesculap Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082991). II is also sub…
Aesculap Implant Systems, Inc.20081
*K080584Metha Short Stem Hip System
Summary page 1
…e BIOLOX® OPTION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aesculap Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082991). II is also substantiall…
Aesculap Implant System, Inc.2008—
*K082146Metha Short Stem Hip System XL Femoral Head
Summary page 1
…ION Ceramic Femoral Head System and Metha XL Heads is a line extension of Aesculap Implant Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aesculap Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082991). II is also substantially equivalent…
Aesculap Implant Systems, Inc.2008—
*K082991Biolox Delta Ceramic Femoral Head
Summary page 1
…Systems Excia (K042344, K060918, and K062684) and Metha (K071916, K080584, and K082146) Hip Systems and Aesculap Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082991). II is also substantially equivalent to the Zimmer BIOLOX® OPTION Ceramic Femoral Head System (K071 535). DEVICE DESCRIPTION The…
Aesculap Implant Systems, Inc.2008—
*K071535Biolox Delta Ceramic Femoral Head
Summary page 1
…Aesculap Implant Systems, Inc. BIOLOX delta Ceramic Femoral Head (K082991). II is also substantially equivalent to the Zimmer BIOLOX® OPTION Ceramic Femoral Head System (K071 535). DEVICE DESCRIPTION The Aesculap Implant Systems BIOLOX® OPTION Ceramic Femoral Head System consist of a ceramic head manufactur…
Zimmer, Inc.20073

Also cleared against K042344: 16 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172235CoreHip® SystemAesculap Implants Systems, LLC20180

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 13 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
  • 31 of the 112 ancestors have a recall of any class.
  • Of its descendants, K172235 (Aesculap Implants Systems, LLC, 2018) has gone furthest, with 0 descendants of its own.
  • 16 other devices also cite its predicate K042344.

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. 2009, 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 Excia Hip System is Intended to replace a hip joint. The device is intended for: Patients suffering from severe hip 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, protrusion acetabuli, or slipped capital femoral epiphysis Patients suffering from disability…

Read the full statement (198 words)

The Excia Hip System is Intended to replace a hip joint.

The device is intended for:

Patients suffering from severe hip 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, protrusion acetabuli, or slipped capital femoral epiphysis

Patients suffering from disability due previous fusion

Patients with acute femoral neck fractures

The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented

fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or without

p-CaP®.

The Methas Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.

The device is intended for:

skeletally mature individuals undergoing primary surgery for total hip replacement

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, protrusion acetabuli, or slipped capital femoral epiphysis

patients suffering from disability due to previous fusion

patients with acute femoral neck fractures

Indications for use as stated in the FDA summary.

Also cleared against K042344

16 other devices cite the same predicate.

  • K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
  • K172235CoreHip® SystemAesculap Implants Systems, LLC · 2018
  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall
  • K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc. · 2013
  • K103431Coren Total Hip SystemCorentec Co., Ltd. · 2011
  • K092143Excia Total Hip System M an ML Femoral StemAesculap Implant Systems, Inc. · 2009

More from Aesculap Implant Systems

7 FDA decisions under this applicant name. See the company

  • K140452Vega Knee SystemAesculap Implant Systems · 2014
  • K121879Vega Knee SystemAesculap Implant Systems · 2012
  • K101815Enduro Knee SystemAesculap Implant Systems · 2010
  • K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems · 20101 recall
  • K090657Modification to: S4 Spinal SystemAesculap Implant Systems · 2009

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/K090299 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090299: Biolox Option Ceramic Femoral Head and Metha XL Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090299

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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