510(k) Report

510(k) · Cleared

Cleared

Mallory-Head Modular Calcar Stems with Interlocking Slots

K042774510(k) TraditionalCleared Jan 21, 2005108-day reviewClass II21 CFR 888.3358

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

Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 21, 2005 as substantially equivalent to K990830 (Biomet, Inc., 2000) and 1 other predicate after a 108-day review. Its family tree reaches back 4 generations to 1994. 38 later devices descend from it.

Decided
Jan 21, 2005
Review
108 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K921274 (1994). 8 ancestors in all. 38 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 3 other ancestors1995: 1 other ancestor2009: 1 descendant cleared2015: 5 descendants cleared2010: 2 descendants cleared2025: 6 descendants cleared2013: 1 descendant cleared2016: 3 descendants cleared2012: 2 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2021: 2 descendants cleared2014: 2 descendants cleared2020: 2 descendants cleared2017: 4 descendants cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 2 descendants clearedK921274 · Metallic Toatal Hip System · Biomet, Inc. · 1994K994038 · Modular Reach Hip · Biomet, Inc. · 1999K022463 · HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral Stems · Biomet Orthopedics, Inc. · 2002K031693 · Mallory/Head Modular Calcar with and Without HA · Biomet, Inc. · 2003 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 9 descendants4 generations forward: 12 descendants5 generations forward: 9 descendants K031693 · Mallory/Head Modular Calcar with and Without HA · Biomet, Inc. · 2003 · recalledK022463 · HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous Femoral Stems · Biomet Orthopedics, Inc. · 2002K994038 · Modular Reach Hip · Biomet, Inc. · 1999K921274 · Metallic Toatal Hip System · Biomet, Inc. · 19940+5
  1. Root · 4 generations backK921274 Metallic Toatal Hip SystemBiomet, Inc. · 1994
  2. 3 generations backK994038 Modular Reach HipBiomet, Inc. · 1999
  3. 2 generations backK022463 HA Modular Reach Proximal Porous and HA Modular Reach Collared…Biomet Orthopedics, Inc. · 2002
  4. 1 generation backK031693 Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003 · Recalled
  5. This deviceK042774 Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005
  6. Descendant · cites it directly · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
  7. Descendant · 2 generations on · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
  8. Descendant · 3 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
  9. Descendant · 3 generations on · 7 of its ownK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
  10. Descendant · 2 generations on · 7 of its ownK100469 Arcos Interlocking Distal StemsBiomet Manufacturing Corp · 2010

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22012: 22013: 12014: 22015: 52016: 32017: 42019: 22020: 22021: 22022: 22023: 12024: 12025: 62026: 2
2009high 6 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 38 · See all
  • K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · cites it directly37descendants
  • K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · 2 generations on27descendants
  • K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 3 generations on13descendants
  • K151739Revision Femoral StemLima Corporate S.P.A. · 2015 · 3 generations on7descendants
  • K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp · 2010 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K921274Metallic Toatal Hip SystemBiomet, Inc.1994—
−3K994038Modular Reach HipBiomet, Inc.1999—
−2K022463HA Modular Reach Proximal Porous and HA Modular Reach Collared Proximal Porous…Biomet Orthopedics, Inc.2002—
−1K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.200316
0 (this device)K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.2005—
+1K090757Biomet Modular Femoral Revision SystemBiomet, Inc.200918
+2K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P.20101
+3K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…Lima Corporate S.P.A.2012—
+3K151739Revision Femoral StemLima Corporate S.P.A.2015—
+2K100469Arcos Interlocking Distal StemsBiomet Manufacturing Corp2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200030

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201220
201310
201420
201550
201630
201740
201920
202020
202120
202220
202310
202410
202560
202620
FIG. 1 — Lineage of K042774, 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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? (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
*K990830Mallory/Head Calcar Replacement with Interlocking Slots BI-Metric Porous Collared Stem…
Summary page 1
…ly Marketed Devices To Which Substantial Equivalence Is Claimed: Interlocking Hip Stems - K990830 Mallory-Heade Modular Calcar with and without HA - K031693 Device Description: The Mallory-Head® Modular Calcar variety of…
Biomet, Inc.2000—
*K031693Mallory/Head Modular Calcar with and Without HA
Summary page 1
…Is Claimed: Interlocking Hip Stems - K990830 Mallory-Heade Modular Calcar with and without HA - K031693 Device Description: The Mallory-Head® Modular Calcar variety of proximal metaphyseal segments and distal stems.System consi…
Biomet, Inc.200316

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K090757Biomet Modular Femoral Revision SystemBiomet, Inc.200937

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 11 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K090757 (Biomet, Inc., 2009) has gone furthest, with 37 descendants of its own.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

Mallory-Head® Modular Calcar Stems with Interlocking Slots 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.

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 LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K042774 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042774: Mallory-Head Modular Calcar Stems with Interlocking Slots.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042774

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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