510(k) Report

510(k) · Cleared

Cleared

Bicontact Hip Stem and Femoral Head

K040191510(k) TraditionalCleared Aug 25, 2004210-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

Aesculap · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Aug 25, 2004 as substantially equivalent to K022077 (Howmedica Osteonics Corp., 2002) and 4 other predicates after a 210-day review. Its family tree reaches back 4 generations to 1996. 267 later devices descend from it.

Decided
Aug 25, 2004
Review
210 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K955033 (1996). 28 ancestors in all, the oldest K840643 (1984). 267 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2002: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1997: 4 other ancestors1995: 1 other ancestor1994: 4 other ancestors1996: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1984: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor2006: 5 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2004: 1 descendant cleared2008: 6 descendants cleared2010: 6 descendants cleared2011: 14 descendants cleared2018: 16 descendants cleared2013: 20 descendants cleared2017: 15 descendants cleared2009: 5 descendants cleared2019: 14 descendants cleared2022: 16 descendants cleared2016: 9 descendants cleared2015: 7 descendants cleared2012: 21 descendants cleared2014: 7 descendants cleared2021: 19 descendants cleared2020: 16 descendants cleared2026: 19 descendants cleared2023: 16 descendants cleared2024: 12 descendants cleared2025: 21 descendants 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. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 9 other ancestors3 generations back: 7 other ancestors4 generations back: 3 other ancestors 1 generation forward: 8 descendants2 generations forward: 23 descendants3 generations forward: 50 descendants4 generations forward: 68 descendants5 generations forward: 44 descendants6 generations forward: 37 descendants7 generations forward: 22 descendants8 generations forward: 9 descendants9 generations forward: 3 descendants10 generations forward: 3 descendants K022902 · 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 · 19960+5+10
  1. Root · 4 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 3 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
  3. 2 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
  4. 1 generation backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
  5. This deviceK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  6. Descendant · cites it directly · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  7. Descendant · cites it directly · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
  8. Descendant · 2 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
  9. Descendant · 3 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  10. Descendant · cites it directly · 90 of its ownK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006

Showing 5 of 267 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 52007: 12008: 62009: 52010: 62011: 142012: 212013: 202014: 72015: 72016: 92017: 152018: 162019: 142020: 162021: 192022: 162023: 162024: 122025: 212026: 19
2004high 21 (2012) · low 1 (2004)2026

Most influential descendants

Showing 5 of 267 · See all
  • K042344Excia Total Hip SystemAesculap, Inc. · 2005 · cites it directly198descendants
  • K043079Bicontact Hip System with U-CapAesculap · 2004 · cites it directly166descendants
  • K093472Trinity Acetabular SystemCorin USA · 2010 · 2 generations on117descendants
  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 3 generations on109descendants
  • K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006 · cites it directly90descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K955033Rim Flare Acetabular ComponentIntermedics Orthopedics1996—
−3K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc.1999—
−2K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc.20003
−1K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002—
0 (this device)K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
+1K042344Excia Total Hip SystemAesculap, Inc.200510
+1K043079Bicontact Hip System with U-CapAesculap2004—
+2K093472Trinity Acetabular SystemCorin USA20101
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
+1K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
198710
199010
199110
199440
199510
199610
199740
199810
199910
200010
200110
200220
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200650
200710
200860
200950
201060
2011140
2012210
2013200
201470
201570
201690
2017150
2018160
2019140
2020160
2021190
2022160
2023160
2024120
2025210
2026190
FIG. 1 — Lineage of K040191, 1996–2026Source: 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 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? (5)

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
*K02207736MM V40 Femoral Head Components (Lfit and Non-Lfit)
Summary page 2
…AL EQUIVALENCE Aesculap believes that the new BiCONTACT Hip Stem and Femoral Head is substantially equivalent in design to: 36mm V40 Femoral Head Components (K022077) * Accolade TMZF Plus HA 1270 Size Hip System (K023102) MAYO Conservative Hip Prosthesis (K030733) S…
Howmedica Osteonics Corp.200212
*K023102Accolade TMZF Plus HA 127 Size 0 Hip Stem
Summary page 2
…tem and Femoral Head is substantially equivalent in design to: 36mm V40 Femoral Head Components (K022077) * Accolade TMZF Plus HA 1270 Size Hip System (K023102) MAYO Conservative Hip Prosthesis (K030733) Smith & Nephew Hip System (K022902) J Zimmer Anatomic (…
Howmedica Osteonics Corp.200213
*K030733Mayo Conservative Hip Prosthesis, Model 8026 Series
Summary page 2
…sign to: 36mm V40 Femoral Head Components (K022077) * Accolade TMZF Plus HA 1270 Size Hip System (K023102) MAYO Conservative Hip Prosthesis (K030733) Smith & Nephew Hip System (K022902) J Zimmer Anatomic (K041 109) DEPARTMENT OF HEALTH &…
Zimmer, Inc.20032
*K022902Smith & Nephew Hip System
Summary page 2
…nents (K022077) * Accolade TMZF Plus HA 1270 Size Hip System (K023102) MAYO Conservative Hip Prosthesis (K030733) Smith & Nephew Hip System (K022902) J Zimmer Anatomic (K041 109) DEPARTMENT OF HEALTH & HUMAN SERVICES…
Smith & Nephew, Inc.2002—
*K041109Zimmer Anatomic II Hip Prosthesis
Cleared while this submission was under review
Summary page 2
…ZF Plus HA 1270 Size Hip System (K023102) MAYO Conservative Hip Prosthesis (K030733) Smith & Nephew Hip System (K022902) J Zimmer Anatomic (K041 109) DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Zimmer, Inc.2004—

Also cleared against K022077: 5 other devices →

What descends from it? (267)

See all 267

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

NumberDeviceApplicantDecidedDescendants
K042344Excia Total Hip SystemAesculap, Inc.2005198
K043079Bicontact Hip System with U-CapAesculap2004166
K060918Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc.200690
K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779
K060707Aesculap Bipolar Acetabular CupAesculap, Inc.200611
K061344Excia Total Hip System Lateral OffsetAesculap, Inc.20064
K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082
K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100

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 8 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 11 of the 27 ancestors have a recall of any class.
  • Of its descendants, K042344 (Aesculap, Inc., 2005) has gone furthest, with 198 descendants of its own.
  • 5 other devices also cite its predicate K022077.

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.

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 BiCONTACT Hip System (prosthesis, hip, semi-constrained, metal/polymer, porous uncemented) is intended to replace a hip joint.

The device is intended for:

· 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 K022077

5 other devices cite the same predicate.

  • K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 20161 recall
  • K110290Exeter Hip StemHowmedica Osteonics Corp. · 20111 recall
  • K061434Trident Large Diameter Hip SystemHowmedica Osteonics Corp. · 20062 recalls
  • K042344Excia Total Hip SystemAesculap, Inc. · 200510 recalls

More from Aesculap

10 FDA decisions under this applicant name. See the company

  • K093649Aesculap Sterilcontainer SAesculap · 2010
  • K062085S4 Spinal SystemAesculap · 2007
  • K062510Aesculap Sterilcontainer SystemAesculap · 2006
  • K061135Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019Aesculap · 2006
  • K043079Bicontact Hip System with U-CapAesculap · 2004

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/K040191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040191: Bicontact Hip Stem and 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/K040191

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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