510(k) Report

510(k) · Cleared

Cleared

Consensus Biolox Delta Ceramic Femoral Head

K110542510(k) TraditionalCleared Apr 1, 201136-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Consensus Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Apr 1, 2011 as substantially equivalent to K935193 (U.S. Medical Products, Inc., 1994) and 18 other predicates after a 36-day review. Its family tree reaches back 9 generations to 1994.

Decided
Apr 1, 2011
Review
36 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
19

Its longest line of descent runs back 9 generations to K941847 (1994). 177 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 2 other ancestors2008: 3 other ancestors2007: 2 other ancestors2006: 5 other ancestors2003: 11 other ancestors2002: 11 other ancestors1996: 17 other ancestors1995: 16 other ancestors1994: 24 other ancestors1993: 3 other ancestors2005: 5 other ancestors2001: 7 other ancestors2000: 13 other ancestors1999: 6 other ancestors1998: 7 other ancestors1992: 5 other ancestors2004: 4 other ancestors1997: 10 other ancestors1983: 1 other ancestor1991: 4 other ancestors1988: 1 other ancestor1986: 2 other ancestors1981: 1 other ancestor1990: 2 other ancestors1987: 2 other ancestors1985: 2 other ancestors1984: 1 other ancestorK941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK060918 · Excia Total Hip System 12/14 Trunnion with Ceramic Head · Aesculap, Inc. · 2006K062684 · Excia Total Hip System 36MM Ceramic Head · Aesculap, Inc. · 2006K081973 · Metha Short Stem Hip System; Modular Hip System; Excia Hip System · Aesculap Implant Systems, Inc. · 20081980198519901995200020052010
Other ancestors, by generation 1 generation back: 18 other ancestors2 generations back: 17 other ancestors3 generations back: 32 other ancestors4 generations back: 35 other ancestors5 generations back: 47 other ancestors6 generations back: 11 other ancestors7 generations back: 7 other ancestors K081973 · Metha Short Stem Hip System; Modular Hip System; Excia Hip System · Aesculap Implant Systems, Inc. · 2008K062684 · Excia Total Hip System 36MM Ceramic Head · Aesculap, Inc. · 2006K060918 · Excia Total Hip System 12/14 Trunnion with Ceramic Head · Aesculap, Inc. · 2006K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994−50
  1. Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 5 generations between
  3. 3 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
  4. 2 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
  5. 1 generation backK081973 Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc. · 2008
  6. This deviceK110542 Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc. · 2011
Show all 9 generations
  1. Root · 9 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 8 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
  3. 7 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
  4. 6 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
  5. 5 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
  6. 4 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  7. 3 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
  8. 2 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
  9. 1 generation backK081973 Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc. · 2008
  10. This deviceK110542 Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K9418475/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc.1994—
−8K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc.1997—
−7K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19981
−6K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000—
−5K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—
−4K042344Excia Total Hip SystemAesculap, Inc.200510
−3K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.2006—
−2K062684Excia Total Hip System 36MM Ceramic HeadAesculap, Inc.2006—
−1K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.2008—
0 (this device)K110542Consensus Biolox Delta Ceramic Femoral HeadConsensus Orthopedics, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
198410
198520
198620
198720
198810
199020
199140
199250
199330
1994240
1995160
1996170
1997100
199870
199960
2000130
200170
2002110
2003110
200440
200550
200650
200720
200830
201020
FIG. 1 — Lineage of K110542, 1994–2011Source: 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (19)

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
*K935193Consensus Hip System- Porous Coated Titianium Femoral Stem
Summary page 2
…ral head with the Consensus hip systems is substantially equivalent to legally marketed predicates. Legally Marketed Devices to which Substantial Equivalence isclaimed: K935 193 (U.S. Medical Products) Consensuis' Hip System -Porous Coated Titanium Fenmoral Stem K(93 5453 (U.S. Medical Products) CONSENSUS(…
U.S. Medical Products, Inc.1994—
*K935453Consensus (TM) Hip System-HA Coated Tianium Fem StemU.S. Medical Products, Inc.1994—
*K933499Consensus Hip System- Non-Porous Titanium Femoral Stem
Summary page 2
…Medical Products) Consensuis' Hip System -Porous Coated Titanium Fenmoral Stem K(93 5453 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K(922561 (U.S. Medical Products) CONSENSUS(TM) TOT…
U.S. Medical Products, Inc.1994—
*K922561Consensus (TM) Total Hip System
Summary page 2
…(U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K(922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K(070061 (Hayes Medical, Inc.) Consensus Hip System 36 mm CoCr Fenmoral He…
U.S. Medical Products, Inc.1993—
*K07006136MM Cocr Femoral Head and 36MM Acetabular Insert
Summary page 2
…IUM FEMORAL STEM K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K(922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K(070061 (Hayes Medical, Inc.) Consensus Hip System 36 mm CoCr Fenmoral Head K(953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE…
Hayes Medical, Inc.2007—
*K953792Consensus Zirconia Head Size -3.5, 0, +5
Summary page 2
…ROUS TITANIUM FEMORAL STEM K(922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K(070061 (Hayes Medical, Inc.) Consensus Hip System 36 mm CoCr Fenmoral Head K(953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD…
U.S. Medical Products, Inc.1995—
*K955386Consensus Zirconia Femoral Head
Summary page 2
…) TOTAL HIP SYSTEM K(070061 (Hayes Medical, Inc.) Consensus Hip System 36 mm CoCr Fenmoral Head K(953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K(960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K(960…
U.S. Medical Products, Inc.1996—
*K960339Consensus 22MM Cocrmo Femoral Head
Summary page 2
…stem 36 mm CoCr Fenmoral Head K(953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K(960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K(960 156 (U.S. Medical Products) CONSENSUS 32MM COCRMO FEMORAL HEAD K…
U.S. Medical Products, Inc.1996—
*K960156Consensus 32MM Cocrmo Femoral HeadU.S. Medical Products, Inc.1996—
*K960151Consensus 26MM Cocrmo Femoral Head
Summary page 2
…CONSENSUS ZIRCONIA FEMORAL HEAD K(960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K(960 156 (U.S. Medical Products) CONSENSUS 32MM COCRMO FEMORAL HEAD K960151l(U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K(060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular…
U.S. Medical Products, Inc.1996—
*K060635Consensus Acetabular Shell System
Summary page 2
…SENSUS 22MM COCRMO FEMORAL HEAD K(960 156 (U.S. Medical Products) CONSENSUS 32MM COCRMO FEMORAL HEAD K960151l(U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K(060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular CLIP K02 1466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CRO…
Hayes Medical, Inc.2006—
*K021466Consensus Acetabular Insert, Cross-Linked Polyethylene
Summary page 2
…US 32MM COCRMO FEMORAL HEAD K960151l(U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K(060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular CLIP K02 1466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Haycs Medical, Inc.) CONSENSUS ACETABLAR SH…
Hayes Medical, Inc.2002—
*K020153Consensus Acetablar Shell, TI Coated
Summary page 2
…RAL HEAD K(060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular CLIP K02 1466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Haycs Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953 198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW KI100933 (Conse…
Hayes Medical, Inc.2002—
*K953198Corticellous Bone Screw
Summary page 2
…Acetabular CLIP K02 1466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Haycs Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953 198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW KI100933 (Consensuls) Consensus Acetabular insert, C52 Plus K(030151 (Hayes Medical…
Hayes Medical, Inc.1995—
*K100933Consensus CS2 Plus Acetabular Insert
Summary page 2
…ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Haycs Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953 198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW KI100933 (Consensuls) Consensus Acetabular insert, C52 Plus K(030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN H-IP SYSTEM K10239…
Consensus Orthopedics, Inc.2010—
*K030151Consensus Hip System, Unisyn Hip System
Summary page 2
…Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953 198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW KI100933 (Consensuls) Consensus Acetabular insert, C52 Plus K(030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN H-IP SYSTEM K102399 (Consensus) TaperSet Hip System K(081973 (Aesculap) Consen…
Hayes Medical, Inc.2003—
*K102399Consensus Taperset Hip System
Summary page 2
…edical, Inc.) CORTICELLOUS BONE SCREW KI100933 (Consensuls) Consensus Acetabular insert, C52 Plus K(030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN H-IP SYSTEM K102399 (Consensus) TaperSet Hip System K(081973 (Aesculap) Consensus Acetabular Cups for use with Aescualp Excia and Metha Hip Systems K…
Consensus Orthopedics, Inc.2010—
*K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip System
Summary page 2
…predicate Aesculap system in basic design and indications. The predicate Aesculap stems and heads were cleared for use with the Consensus CS2 Acetabular Cup System under K08 1973. Zirconia ceramic femoral heads were previously cleared with CUS, Unisyn, and TUS under various 5 10(k) submissions. The subject…
Aesculap Implant Systems, Inc.2008—
*K082991Biolox Delta Ceramic Femoral Head
Summary page 2
…CUS, Unisyn, and TUS under various 5 10(k) submissions. The subject Biolox delta ceramic femoral heads were cleared for use with the predicate Aesculap hip systems under K082991. Based on the material, characterization data, geometry and mechanical testing, use of the Biolox delta femoral head with the Con…
Aesculap Implant Systems, Inc.2008—

Also cleared against K935193: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 17 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
  • 37 of the 176 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K935193.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications. The general indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D.…

Read the full statement (123 words)

The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications.

The general indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.

C. Proximal femoral fractures.

D. Avascular necrosis of the femoral head.

E. Non-union of proximal femoral neck fractures.

F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

Indications for use as stated in the FDA summary.

Also cleared against K935193

3 other devices cite the same predicate.

  • K122512CS2 Hip SystemConsensus Orthopedics, Inc. · 2012
  • K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc. · 2012
  • K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010

More from Consensus Orthopedics, Inc.

17 FDA decisions under this applicant name. See the company

  • K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. · 2017
  • K163167CKS Plus Knee SystemConsensus Orthopedics, Inc. · 2017
  • K160515PS2 Knee SystemConsensus Orthopedics, Inc. · 2016
  • K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc. · 2015
  • K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc. · 2014

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K110542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110542: Consensus Biolox Delta Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110542

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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