510(k) Report

510(k) · Cleared

Cleared

Taperloc Complete

K101086510(k) TraditionalCleared Sep 3, 2010137-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, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Sep 3, 2010 after a 137-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.

Decided
Sep 3, 2010
Review
137 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
0

50 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2019: 6 descendants cleared2020: 2 descendants cleared2011: 2 descendants cleared2012: 4 descendants cleared2014: 5 descendants cleared2017: 3 descendants cleared2026: 7 descendants cleared2023: 3 descendants cleared2022: 2 descendants cleared2024: 6 descendants cleared2018: 1 descendant cleared2021: 2 descendants cleared2016: 3 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2025: 2 descendants cleared2010201520202025
  1. This deviceK101086 Taperloc CompleteBiomet, Inc. · 2010
  2. Descendant · cites it directly · 48 of its ownK103755 Taperloc Complete, Size 5 and 6Biomet Manufacturing Corp · 2011
  3. Descendant · cites it directly · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  4. Descendant · 2 generations on · 20 of its ownK121935 Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012
  5. Descendant · 3 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
  6. Descendant · cites it directly · 14 of its ownK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2011: 22012: 42013: 12014: 52015: 12016: 32017: 32018: 12019: 62020: 22021: 22022: 22023: 32024: 62025: 22026: 7
2011high 7 (2026) · low 1 (2013)2026

Most influential descendants

Showing 5 of 50 · See all
  • K103755Taperloc Complete, Size 5 and 6Biomet Manufacturing Corp · 2011 · cites it directly48descendants
  • K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · cites it directly34descendants
  • K121935Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012 · 2 generations on20descendants
  • K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 3 generations on19descendants
  • K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012 · cites it directly14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K101086Taperloc CompleteBiomet, Inc.2010—
+1K103755Taperloc Complete, Size 5 and 6Biomet Manufacturing Corp2011—
+1K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
+2K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.2012—
+3K161184iNSitu Total Hip SystemTheken Companies, LLC2016—
+1K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201240
201310
201450
201510
201630
201730
201810
201960
202020
202120
202220
202330
202460
202520
202670
FIG. 1 — Lineage of K101086, 2010–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (50)

See all 50

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

NumberDeviceApplicantDecidedDescendants
K103755Taperloc Complete, Size 5 and 6Biomet Manufacturing Corp201148
K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134
K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214
K163577Ecofit® Hip SystemImplantcast GmbH20179
K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122
K200196Taperloc® Complete Hip StemsBiomet Orthopedics20201
K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191
K140674Exactech Tapered Wedge Femoral StemExactech, Inc.20141
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?

  • Of its descendants, K103755 (Biomet Manufacturing Corp, 2011) has gone furthest, with 48 descendants of its own.

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. 2010, 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—

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K101086 · printed Nov 5, 2026

Cite this page

510(k) Report. “K101086: Taperloc Complete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101086

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026