510(k) Report

510(k) · Cleared

Cleared

Mallory Head Modular Calcar

K001660510(k) SpecialCleared Jun 14, 200014-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 Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jun 14, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.

Decided
Jun 14, 2000
Review
14 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

48 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared2010: 3 descendants cleared2015: 5 descendants cleared2025: 9 descendants cleared2013: 1 descendant cleared2016: 3 descendants cleared2024: 3 descendants cleared2022: 3 descendants cleared2026: 2 descendants cleared2012: 2 descendants cleared2019: 2 descendants cleared2021: 2 descendants cleared2014: 2 descendants cleared2020: 2 descendants cleared2017: 4 descendants cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK001660 Mallory Head Modular CalcarBiomet Orthopedics, Inc. · 2000
  2. Descendant · cites it directly · 39 of its ownK031693 Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 38 of its ownK042774 Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005
  4. Descendant · 2 generations on · 37 of its ownK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
  5. Descendant · 3 generations on · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
  6. Descendant · 4 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 12009: 12010: 32012: 22013: 12014: 22015: 52016: 32017: 42019: 22020: 22021: 22022: 32023: 12024: 32025: 92026: 2
2003high 9 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 48 · See all
  • K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc. · 2003 · cites it directly39descendants
  • K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc. · 2005 · 2 generations on38descendants
  • K090757Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · 2 generations on37descendants
  • K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · 3 generations on27descendants
  • K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001660Mallory Head Modular CalcarBiomet Orthopedics, Inc.2000—
+1K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.200316
+2K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.2005—
+2K090757Biomet Modular Femoral Revision SystemBiomet, Inc.200918
+3K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P.20101
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…Lima Corporate S.P.A.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200510
200910
201030
201220
201310
201420
201550
201630
201740
201920
202020
202120
202230
202310
202430
202590
202620
FIG. 1 — Lineage of K001660, 2000–2026Source: 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 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?

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

What descends from it? (48)

See all 48

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

NumberDeviceApplicantDecidedDescendants
K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.200339
K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048

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, K031693 (Biomet, Inc., 2003) has gone furthest, with 39 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—

More from Biomet Orthopedics, Inc.

35 FDA decisions under this applicant name. See the company

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  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 20082 recalls
  • K070955Acid Etched Lag ScrewsBiomet Orthopedics, Inc. · 2007
  • K033355Lactoscrew Screw AnchorBiomet Orthopedics, Inc. · 2004

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/K001660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001660: Mallory Head Modular Calcar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001660

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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