510(k) Report

510(k) · Cleared

Cleared

HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral Stem

K021403510(k) SpecialCleared May 31, 200229-day reviewClass II21 CFR 888.3353

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

Biomet Orthopedics, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Cleared on May 31, 2002 as substantially equivalent to K921181 (Biomet, Inc., 1994) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1994. 132 later devices descend from it.

Decided
May 31, 2002
Review
29 days
Class
Class II
Product code
MEH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K921181 (1994). 3 ancestors in all. 132 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2005: 1 descendant cleared2008: 3 descendants cleared2017: 4 descendants cleared2011: 4 descendants cleared2012: 3 descendants cleared2010: 2 descendants cleared2009: 2 descendants cleared2013: 2 descendants cleared2018: 5 descendants cleared2015: 3 descendants cleared2014: 3 descendants cleared2021: 9 descendants cleared2020: 6 descendants cleared2019: 5 descendants cleared2023: 14 descendants cleared2026: 20 descendants cleared2024: 14 descendants cleared2025: 19 descendants cleared2022: 12 descendants cleared2016: 1 descendant clearedK921181 · Mallory-Head Total Hip System · Biomet, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 8 descendants4 generations forward: 12 descendants5 generations forward: 20 descendants6 generations forward: 29 descendants7 generations forward: 28 descendants8 generations forward: 16 descendants9 generations forward: 11 descendants10 generations forward: 4 descendants K921181 · Mallory-Head Total Hip System · Biomet, Inc. · 19940+5+10
  1. Root · 1 generation backK921181 Mallory-Head Total Hip SystemBiomet, Inc. · 1994
  2. This deviceK021403 HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous…Biomet Orthopedics, Inc. · 2002
  3. Descendant · cites it directly · 131 of its ownK043123 Apex Modular HA Hip StemApex Surgical, LLC · 2005
  4. Descendant · 2 generations on · 68 of its ownK071916 Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
  6. Descendant · 3 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
  7. Descendant · 3 generations on · 59 of its ownK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009

Showing 5 of 132 descendants. See all descendants

Descendants cleared per year

2005: 12008: 32009: 22010: 22011: 42012: 32013: 22014: 32015: 32016: 12017: 42018: 52019: 52020: 62021: 92022: 122023: 142024: 142025: 192026: 20
2005high 20 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 132 · See all
  • K043123Apex Modular HA Hip StemApex Surgical, LLC · 2005 · cites it directly131descendants
  • K071916Metha Hip SystemAesculap Implant Systems, Inc. · 2008 · 2 generations on68descendants
  • K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · 2 generations on61descendants
  • K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 3 generations on60descendants
  • K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009 · 3 generations on59descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921181Mallory-Head Total Hip SystemBiomet, Inc.1994—
0 (this device)K021403HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized…Biomet Orthopedics, Inc.2002—
+1K043123Apex Modular HA Hip StemApex Surgical, LLC2005—
+2K071916Metha Hip SystemAesculap Implant Systems, Inc.20081
+2K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.2008—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp2013—
+3K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200830
200920
201020
201140
201230
201320
201430
201530
201610
201740
201850
201950
202060
202190
2022120
2023140
2024140
2025190
2026200
FIG. 1 — Lineage of K021403, 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 MEH? 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 MEH device

  1. #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 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? (3)

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
*K921181Mallory-Head Total Hip System
Summary page 1
…ous, calcium-phosphate Device Classification: Class II Legally Marketed Device to which Substantially Equivalence is Claimed: Mallory/Head® Porous Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429. Device Description: The HA Mallory/Head® Porous F…
Biomet, Inc.1994—
*K000538Mallory/Head Lateralized Press-Fit Femoral
Summary page 1
…arketed Device to which Substantially Equivalence is Claimed: Mallory/Head® Porous Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429. Device Description: The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems a…
Biomet, Inc.2000—
*K003429Malloy/Head Lateralized Press-Fit Femoral
Summary page 1
…ce to which Substantially Equivalence is Claimed: Mallory/Head® Porous Femoral Stem 510(k)- K921181 and Mallory/Head® Lateralized Press-Fit Femorals 510(k)s- K000538 and K003429. Device Description: The HA Mallory/Head® Porous Femoral Stems & HA Mallory/Head® Porous Lateralized Femoral Stems are the same…
Biomet, Inc.20001

Also cleared against K921181: 5 other devices →

What descends from it? (132)

See all 132

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

NumberDeviceApplicantDecidedDescendants
K043123Apex Modular HA Hip StemApex Surgical, LLC2005131

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K043123 (Apex Surgical, LLC, 2005) has gone furthest, with 131 descendants of its own.
  • 5 other devices also cite its predicate K921181.

How does its category compare?

All MEH devices

MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MEH

5in 2025

2007: 22008: 62009: 62010: 52011: 52012: 62013: 12015: 22016: 62017: 32018: 22019: 12020: 32021: 32022: 32023: 22024: 62025: 52026 (partial year): 1
2007high 6 (2008) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEH

87in 2025

2008: 79 days median2009: 65 days median2010: 226 days median2011: 95 days median2012: 131 days median2016: 163 days median2017: 209 days median2020: 131 days median2021: 83 days median2022: 150 days median2024: 91 days median2025: 87 days median
2007high 226 (2010) · low 65 (2009)2026

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

Recalls per year · MEH

1in 2025

2007: 32008: 802009: 512010: 162011: 42012: 32014: 12015: 12016: 42017: 12018: 32020: 12025: 12026 (partial year): 1
2007high 80 (2008) · low 0 (2013)2026

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

Adverse event reports per year · MEH

470in 2025

2007: 252008: 2612009: 5392010: 4622011: 4192012: 1,6062013: 1,2952014: 1,1962015: 4902016: 3472017: 3832018: 3372019: 3352020: 3382021: 3722022: 3162023: 3342024: 3542025: 470
2007high 1,606 (2012) · low 25 (2007)2025

MAUDE reports naming product code MEH, 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
20072—325
200867980261
200966551539
2010522616462
20115954419
2012613131,606
20131—01,295
20140—11,196
20152—1490
201661634347
201732091383
20182—3337
20191—0335
202031311338
20213830372
202231500316
20232—0334
20246910354
20255871470
20261—1—

What is it indicated for?

The HA Mallory/Head® Porous Femoral Stem & HA Mallory/Head® Porous Lateralized Femoral Stem are indicated for use 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 using other techniques; and 5) Revision procedures where other treatments or devices have failed.

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 K921181

5 other devices cite the same predicate.

  • K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp. · 2014
  • K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 20074 recalls
  • K050251Balance Hip SystemBiomet, Inc. · 2005
  • K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd. · 200071 recalls
  • K980020Activelock Modular Femoral Hip SystemMetagen, LLC · 1998

More from Biomet Orthopedics, Inc.

35 FDA decisions under this applicant name. See the company

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 20082 recalls
  • K070955Acid Etched Lag ScrewsBiomet Orthopedics, Inc. · 2007
  • K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004

Recent decisions in MEH

The MEH category page

  • K261576Icona Hip StemCorin, Ltd. · 2026
  • K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
  • K251166Mfinity Femoral SystemMedacta International S.A. · 2025
  • K251052Trivicta® Hip StemOrtho Development Corp. · 2025
  • K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025

https://510kreport.com/device/K021403 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021403: HA Mallory/Head Porous Femoral Stem & HA Mallory/Head Porous Lateralized Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021403

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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