510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Mallory-Head Modular Calcar Repacement Components

K945115510(k) TraditionalCleared May 2, 1995196-day reviewClass II21 CFR 888.3350Recalls 1

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 May 2, 1995 after a 196-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 537 later devices descend from it. It has been recalled once.

Decided
May 2, 1995
Review
196 days
Class
Class II
Product code
JDI
Recalls
1
Predicates
0

537 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2003: 2 descendants cleared1998: 2 descendants cleared2009: 7 descendants cleared2005: 4 descendants cleared2004: 1 descendant cleared2019: 39 descendants cleared2012: 28 descendants cleared2011: 14 descendants cleared2007: 5 descendants cleared2006: 2 descendants cleared2015: 27 descendants cleared2010: 10 descendants cleared2025: 43 descendants cleared2013: 35 descendants cleared2016: 28 descendants cleared2008: 4 descendants cleared2014: 30 descendants cleared2022: 36 descendants cleared2017: 25 descendants cleared2021: 33 descendants cleared2018: 26 descendants cleared2020: 35 descendants cleared2024: 34 descendants cleared2026: 34 descendants cleared2023: 32 descendants cleared1995200020052010201520202025
  1. This deviceK945115 Mallory-Head Modular Calcar Repacement ComponentsBiomet, Inc. · 1995
  2. Descendant · cites it directly · 508 of its ownK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. Descendant · 2 generations on · 505 of its ownK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. Descendant · 3 generations on · 355 of its ownK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. Descendant · 4 generations on · 344 of its ownK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. Descendant · 5 generations on · 343 of its ownK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006

Showing 5 of 537 descendants. See all descendants

Descendants cleared per year

1998: 22000: 12003: 22004: 12005: 42006: 22007: 52008: 42009: 72010: 102011: 142012: 282013: 352014: 302015: 272016: 282017: 252018: 262019: 392020: 352021: 332022: 362023: 322024: 342025: 432026: 34
1998high 43 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 537 · See all
  • K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998 · cites it directly508descendants
  • K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · 2 generations on505descendants
  • K042051Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · 3 generations on355descendants
  • K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · 4 generations on344descendants
  • K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006 · 5 generations on343descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945115Mallory-Head Modular Calcar Repacement ComponentsBiomet, Inc.1995—
+1K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
+2K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
+3K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
+4K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
+5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200010
200320
200410
200540
200620
200750
200840
200970
2010100
2011140
2012280
2013350
2014300
2015270
2016280
2017250
2018260
2019390
2020350
2021330
2022360
2023320
2024340
2025430
2026340
FIG. 1 — Lineage of K945115, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
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? (537)

See all 537

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

NumberDeviceApplicantDecidedDescendants
K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998508
K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.200339
K000335Mallory-Head Modular Calcar Total Hip SystemBiomet, Inc.20000
K980239Partnership Calcar Femoral ComponentsHowmedica, Inc.19980

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2020Class IIZ-0622-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K974558 (Biomet, Inc., 1998) has gone furthest, with 508 descendants of its own.

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—

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/K945115 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945115: Mallory-Head Modular Calcar Repacement Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945115

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026