510(k) Report

510(k) · Cleared

Cleared

Taper 2 Porous Femoral Stem

K050441510(k) TraditionalCleared Jun 29, 2005127-day reviewClass II21 CFR 888.3350

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

Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Jun 29, 2005 as substantially equivalent to K921301 (Biomet, Inc., 1994) and 1 other predicate after a 127-day review. Its family tree reaches back 1 generation to 1994. 85 later devices descend from it.

Decided
Jun 29, 2005
Review
127 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K921301 (1994). 2 ancestors in all. 85 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2007: 1 descendant cleared2019: 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. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 16 descendants4 generations forward: 32 descendants5 generations forward: 16 descendants6 generations forward: 14 descendants7 generations forward: 1 descendant K921301 · Taperloc Femoral Stem and Universal Acetabular Com · Biomet, Inc. · 19940+5
  1. Root · 1 generation backK921301 Taperloc Femoral Stem and Universal Acetabular ComBiomet, Inc. · 1994
  2. This deviceK050441 Taper 2 Porous Femoral StemBiomet, Inc. · 2005
  3. Descendant · cites it directly · 84 of its ownK062994 Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp · 2007
  4. Descendant · 2 generations on · 44 of its ownK072417 Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
  6. Descendant · 3 generations on · 19 of its ownK080625 Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · Recalled
  7. Descendant · 4 generations on · 16 of its ownK103256 Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · Recalled

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32010: 22011: 32012: 82013: 72014: 52015: 22016: 42017: 72018: 42019: 42020: 12021: 42022: 42023: 52024: 82025: 42026: 9
2007high 9 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 85 · See all
  • K062994Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp · 2007 · cites it directly84descendants
  • K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc. · 2008 · 2 generations on44descendants
  • K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · 2 generations on34descendants
  • K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc. · 2008 · 3 generations on19descendants
  • K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc. · 2011 · 4 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921301Taperloc Femoral Stem and Universal Acetabular ComBiomet, Inc.1994—
0 (this device)K050441Taper 2 Porous Femoral StemBiomet, Inc.2005—
+1K062994Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp2007—
+2K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.20081
+2K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp2011—
+3K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.20081
+4K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.20112

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
201020
201130
201280
201370
201450
201520
201640
201770
201840
201940
202010
202140
202240
202350
202480
202540
202690
FIG. 1 — Lineage of K050441, 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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
*K921301Taperloc Femoral Stem and Universal Acetabular Com
Summary page 2
…R§888.3390), Product Code: KWY Legally Marketed Devices To Which Substantial Equivalence Is Claimed: TaperLoc® Porous and Reduced Distal Femoral Stems - Biomet (K921301) Mayo® Conservative Hip Prosthesis - Zimmer Inc. (K943230)…
Biomet, Inc.1994—
*K943230Mayo Hip Prosthesis
Summary page 2
…Substantial Equivalence Is Claimed: TaperLoc® Porous and Reduced Distal Femoral Stems - Biomet (K921301) Mayo® Conservative Hip Prosthesis - Zimmer Inc. (K943230) to provide Device Description…
Mayo Clinic1997—

Also cleared against K921301: 13 other devices →

What descends from it? (85)

See all 85

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062994Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp200784

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K062994 (Biomet Manufacturing Corp, 2007) has gone furthest, with 84 descendants of its own.
  • 13 other devices also cite its predicate K921301.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

The Taper 2 Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Revision of previously failed…

Read the full statement (225 words)

The Taper 2 Porous Femoral Stem is indicated for use in patients requiring total hip replacement due to the following:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

* Rheumatoid arthritis

* Correction of functional deformity

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

* Revision of previously failed femoral head resurfacing component

Taper 2 Porous Femoral Stems are intended for uncemented use only.

Specific indications for compatible components that can be used with the above femoral stems include:

Constrained Liners (LK030047)

Constrained liners are intended for general use in skeletally 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.

OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871)

Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis.

Interlocking Stems (K990830, K042774)

Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.

Indications for use as stated in the FDA summary.

Also cleared against K921301

13 other devices cite the same predicate.

  • K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc. · 2019
  • K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2019
  • K121034Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
  • K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 20121 recall
  • K110245United Utf StemUnited Orthopedic Corporation · 20111 recall
  • K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010

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 JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K050441 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050441: Taper 2 Porous Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050441

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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