510(k) Report

510(k) · Cleared

Cleared

Taperloc Complete Microplasty Stem

K110400510(k) TraditionalCleared Sep 30, 2011231-day reviewClass III21 CFR 888.3330

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

Biomet Manufacturing Corp · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Sep 30, 2011 as substantially equivalent to K101086 (Biomet, Inc., 2010) and 3 other predicates after a 231-day review. Its family tree reaches back 6 generations to 1985. 34 later devices descend from it.

Decided
Sep 30, 2011
Review
231 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K850055 (1985). 50 ancestors in all, the oldest K845025 (1985). 34 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2007: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2003: 2 other ancestors2004: 2 other ancestors2002: 2 other ancestors1997: 3 other ancestors1996: 4 other ancestors1994: 6 other ancestors2001: 2 other ancestors2000: 5 other ancestors1999: 2 other ancestors1998: 2 other ancestors1990: 1 other ancestor1987: 2 other ancestors1995: 2 other ancestors1988: 2 other ancestors1985: 1 other ancestor1991: 1 other ancestor2012: 3 descendants cleared2019: 4 descendants cleared2014: 4 descendants cleared2017: 2 descendants cleared2026: 5 descendants cleared2020: 1 descendant cleared2016: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2024: 3 descendants cleared2018: 1 descendant cleared2021: 2 descendants cleared2025: 2 descendants clearedK850055 · Profile Femoral Hip · Depuy, Inc. · 1985K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalled×2: 2 generations cleared close together, K992667 (1999), K994286 (2000) K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 8 other ancestors4 generations back: 18 other ancestors5 generations back: 10 other ancestors6 generations back: 2 other ancestors 1 generation forward: 9 descendants2 generations forward: 16 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants K071723 · Zimmer Porolock Mis Stem · Zimmer GmbH · 2008 · recalledK032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK994286 · ZMR Hip System-Porous Revision · Zimmer, Inc. · 2000 · recalledK992667 · ZMR Hip System-Revision Taper · Zimmer, Inc. · 1999 · recalledK961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK850055 · Profile Femoral Hip · Depuy, Inc. · 1985−50
  1. Root · 6 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 5 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 4 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  4. 3 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  5. 2 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  6. 1 generation backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
  7. This deviceK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  8. Descendant · cites it directly · 14 of its ownK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
  9. Descendant · cites it directly · 11 of its ownK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
  10. Descendant · cites it directly · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
  11. Descendant · 2 generations on · 8 of its ownK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
  12. Descendant · 2 generations on · 7 of its ownK132572 I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC · 2014

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2012: 32013: 12014: 42015: 12016: 22017: 22018: 12019: 42020: 12021: 22022: 12023: 22024: 32025: 22026: 5
2012high 5 (2026) · low 1 (2013)2026

Most influential descendants

Showing 5 of 34 · See all
  • K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012 · cites it directly14descendants
  • K121034Ioi Total HipIconacy Orthopedic Implants, LLC · 2012 · cites it directly11descendants
  • K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · cites it directly9descendants
  • K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013 · 2 generations on8descendants
  • K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC · 2014 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K850055Profile Femoral HipDepuy, Inc.1985—
−5K961378Delta Hip ProsthesisZimmer, Inc.19964
−4K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
−3K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
−2K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
−1K071723Zimmer Porolock Mis StemZimmer GmbH20082
0 (this device)K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
+1K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp2012—
+1K121034Ioi Total HipIconacy Orthopedic Implants, LLC2012—
+1K163577Ecofit® Hip SystemImplantcast GmbH20171
+2K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC2013—
+2K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198720
198820
199010
199110
199460
199520
199640
199730
199820
199920
200050
200120
200220
200320
200420
200510
200610
200710
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201310
201440
201510
201620
201720
201810
201940
202010
202120
202210
202320
202430
202520
202650
FIG. 1 — Lineage of K110400, 1985–2026Source: 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K101086Taperloc Complete
Summary page 2
…Main Fax: 574-267-8137 w'ww.biomnet~comn Legally Marketed Devices To Which Substantial Equivalence Is Claimed: TaperlocO Complete Stems-Biomet-(K101086) Lateralized Taperloc® Microplasty Femoral Components -Biomet-(K062994) Taperloc® Complete, Sizes 5mm and 6mm-Biomnet--(K…
Biomet, Inc.2010—
*K062994Lateralized Taperloc Microplasty Femoral Components
Summary page 2
…ted Devices To Which Substantial Equivalence Is Claimed: TaperlocO Complete Stems-Biomet-(K101086) Lateralized Taperloc® Microplasty Femoral Components -Biomet-(K062994) Taperloc® Complete, Sizes 5mm and 6mm-Biomnet--(K103755) Fitmore® Hip Stem-Zimmer-(K071723) Device Description: The T…
Biomet Manufacturing Corp2007—
*K103755Taperloc Complete, Size 5 and 6
Summary page 2
…TaperlocO Complete Stems-Biomet-(K101086) Lateralized Taperloc® Microplasty Femoral Components -Biomet-(K062994) Taperloc® Complete, Sizes 5mm and 6mm-Biomnet--(K103755) Fitmore® Hip Stem-Zimmer-(K071723) Device Description: The Taperloc® Complete Microplasty Stems are an update to the exis…
Biomet Manufacturing Corp2011—
*K071723Zimmer Porolock Mis Stem
Summary page 2
…86) Lateralized Taperloc® Microplasty Femoral Components -Biomet-(K062994) Taperloc® Complete, Sizes 5mm and 6mm-Biomnet--(K103755) Fitmore® Hip Stem-Zimmer-(K071723) Device Description: The Taperloc® Complete Microplasty Stems are an update to the existing Taperoc® Microplasty Stems and are…
Zimmer GmbH20082

Also cleared against K101086: 8 other devices →

What descends from it? (34)

See all 34

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

NumberDeviceApplicantDecidedDescendants
K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214
K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211
K163577Ecofit® Hip SystemImplantcast GmbH20179
K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143
K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122
K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191
K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141
K251270Taperloc® Complete Hip StemBiomet, Inc.20260
K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190

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 26 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
  • 12 of the 50 ancestors have a recall of any class.
  • Of its descendants, K120030 (Biomet Manufacturing Corp, 2012) has gone furthest, with 14 descendants of its own.
  • 8 other devices also cite its predicate K101086.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, 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
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

What is it indicated for?

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis

3. Correction of functional deformity

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.

5. Revision procedures where other treatment or devices have failed.

Porous coated components are intended for uncemented biological fixation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K101086

8 other devices cite the same predicate.

  • K200196Taperloc® Complete Hip StemsBiomet Orthopedics · 2020
  • K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc. · 2019
  • K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall
  • K140674Exactech Tapered Wedge Femoral StemExactech, Inc. · 2014
  • K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc. · 2012

More from Biomet Manufacturing Corp

201 FDA decisions under this applicant name. See the company

  • P010014/S119Cementless Oxford Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp · 2026
  • P010014/S117Oxford™ Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S112Oxford Partial Knee System; Cementless Oxford™Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S116Oxford® Partial Knee SystemBiomet Manufacturing Corp · 2026

Recent decisions in KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K110400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110400: Taperloc Complete Microplasty Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110400

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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