510(k) Report

510(k) · Cleared

Cleared

Lateralized Taperloc Microplasty Femoral Components

K062994510(k) SpecialCleared Mar 9, 2007158-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 Mar 9, 2007 as substantially equivalent to K050441 (Biomet, Inc., 2005) after a 158-day review. Its family tree reaches back 2 generations to 1994. 84 later devices descend from it.

Decided
Mar 9, 2007
Review
158 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K921301 (1994). 3 ancestors in all. 84 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2019: 4 descendants cleared2011: 3 descendants cleared2012: 8 descendants cleared2008: 3 descendants cleared2010: 2 descendants cleared2014: 5 descendants cleared2017: 7 descendants cleared2026: 9 descendants cleared2016: 4 descendants cleared2021: 4 descendants cleared2013: 7 descendants cleared2018: 4 descendants cleared2022: 4 descendants cleared2024: 8 descendants cleared2020: 1 descendant cleared2015: 2 descendants cleared2023: 5 descendants cleared2025: 4 descendants clearedK921301 · Taperloc Femoral Stem and Universal Acetabular Com · Biomet, Inc. · 1994K050441 · Taper 2 Porous Femoral Stem · Biomet, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 16 descendants3 generations forward: 32 descendants4 generations forward: 16 descendants5 generations forward: 14 descendants6 generations forward: 1 descendant K050441 · Taper 2 Porous Femoral Stem · Biomet, Inc. · 2005K921301 · Taperloc Femoral Stem and Universal Acetabular Com · Biomet, Inc. · 19940+5
  1. Root · 2 generations backK921301 Taperloc Femoral Stem and Universal Acetabular ComBiomet, Inc. · 1994
  2. 1 generation backK050441 Taper 2 Porous Femoral StemBiomet, Inc. · 2005
  3. This deviceK062994 Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp · 2007
  4. Descendant · cites it directly · 44 of its ownK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
  5. Descendant · cites it directly · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  6. Descendant · 2 generations on · 19 of its ownK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · Recalled
  7. Descendant · 3 generations on · 16 of its ownK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled
  8. Descendant · 2 generations on · 15 of its ownK083312 Minihip StemCorin USA · 2010

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

2008: 32010: 22011: 32012: 82013: 72014: 52015: 22016: 42017: 72018: 42019: 42020: 12021: 42022: 42023: 52024: 82025: 42026: 9
2008high 9 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 84 · See all
  • K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · cites it directly44descendants
  • K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · cites it directly34descendants
  • K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · 2 generations on19descendants
  • K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · 3 generations on16descendants
  • K083312Minihip StemCorin USA · 2010 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921301Taperloc Femoral Stem and Universal Acetabular ComBiomet, Inc.1994—
−1K050441Taper 2 Porous Femoral StemBiomet, Inc.2005—
0 (this device)K062994Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp2007—
+1K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.20081
+1K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
+2K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.20081
+3K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.20112
+2K083312Minihip StemCorin USA2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200830
201020
201130
201280
201370
201450
201520
201640
201770
201840
201940
202010
202140
202240
202350
202480
202540
202690
FIG. 1 — Lineage of K062994, 1994–2026Source: 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? (1)

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
*K050441Taper 2 Porous Femoral Stem
Summary page 1
…Subsequent Product Codes: KWZ, JDL, .JDI, LZO, MEH, LPH, MBL, KWY Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Taper2 TM Porous femoral Stem - K050441 Device Description: The Lateralized Taperloc® Microplasty Tm Femoral Components are straight, collarless, flat, tapered stems de…
Biomet, Inc.2005—

What descends from it? (84)

See all 84

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

NumberDeviceApplicantDecidedDescendants
K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.200844
K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134
K121563Corin Trifit TS HipCorin USA201210
K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191
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 13 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K072417 (Smith & Nephew, Inc., 2008) has gone furthest, with 44 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. 2007, 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?

The Lateralized Taperloc® Microplasty TM Femoral Components are indicated for use in patients requiring hip replacement due to the following: 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)…

Read the full statement (154 words)

The Lateralized Taperloc® Microplasty TM Femoral Components are indicated for use in

patients requiring hip replacement due to the following:

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 of previously failed femoral head resurfacing component

The Lateralized Taperloc® Microplasty TM Femoral Components are intended for

uncemented use only.

Specific indications for compatible components that can be used with the Lateralized

Taperloc® Microplasty TM femoral Components include:

Constrained Liners (K030047)

Constrained liners are intended for general use inskeletally mature individuals

undergoing primary and/or revision surgery at high risk of hip dislocation due to history of

prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or

intra-operative instability and for whom all other options to constrained acetabular

components have been considered.

Indications for use as stated in the FDA summary.

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

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  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
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https://510kreport.com/device/K062994 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062994: Lateralized Taperloc Microplasty Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062994

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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