510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components

K030055510(k) TraditionalCleared Aug 11, 2003217-day reviewClass II21 CFR 888.3358Recalls 3

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 Aug 11, 2003 as substantially equivalent to K984296 (Biomet, Inc., 1999) and 4 other predicates after a 217-day review. Its family tree reaches back 2 generations to 1985. 208 later devices descend from it. It has been recalled 3 times.

Decided
Aug 11, 2003
Review
217 days
Class
Class II
Product code
LPH
Recalls
3
Predicates
5

Its longest line of descent runs back 2 generations to K854046 (1985). 15 ancestors in all. 208 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 5 other ancestors1986: 1 other ancestor2012: 15 descendants cleared2005: 5 descendants cleared2006: 2 descendants cleared2011: 4 descendants cleared2007: 3 descendants cleared2019: 21 descendants cleared2008: 2 descendants cleared2014: 16 descendants cleared2013: 10 descendants cleared2016: 9 descendants cleared2010: 2 descendants cleared2015: 11 descendants cleared2017: 12 descendants cleared2009: 1 descendant cleared2025: 16 descendants cleared2026: 17 descendants cleared2020: 8 descendants cleared2023: 14 descendants cleared2024: 13 descendants cleared2018: 7 descendants cleared2022: 12 descendants cleared2021: 8 descendants clearedK854046 · Conical Collar Hip Prosthesis · Kirschner Medical Corp. · 1985K960303 · Fenning Femoral Component · Biomet, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 9 other ancestors 1 generation forward: 6 descendants2 generations forward: 27 descendants3 generations forward: 65 descendants4 generations forward: 45 descendants5 generations forward: 36 descendants6 generations forward: 18 descendants7 generations forward: 5 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants K960303 · Fenning Femoral Component · Biomet, Inc. · 1996K854046 · Conical Collar Hip Prosthesis · Kirschner Medical Corp. · 19850+5
  1. Root · 2 generations backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
  2. 1 generation backK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
  3. This deviceK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003
  4. Descendant · cites it directly · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  5. Descendant · cites it directly · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
  6. Descendant · 2 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
  7. Descendant · 3 generations on · 65 of its ownK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · Recalled
  8. Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled

Showing 5 of 208 descendants. See all descendants

Descendants cleared per year

2005: 52006: 22007: 32008: 22009: 12010: 22011: 42012: 152013: 102014: 162015: 112016: 92017: 122018: 72019: 212020: 82021: 82022: 122023: 142024: 132025: 162026: 17
2005high 21 (2019) · low 1 (2009)2026

Most influential descendants

Showing 5 of 208 · See all
  • K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · cites it directly160descendants
  • K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · cites it directly138descendants
  • K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · 2 generations on137descendants
  • K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · 3 generations on65descendants
  • K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K854046Conical Collar Hip ProsthesisKirschner Medical Corp.1985—
−1K960303Fenning Femoral ComponentBiomet, Inc.1996—
0 (this device)K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…Biomet, Inc.2003—
+1K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
+1K050124Porous Coated Acetabular ComponentsBiomet, Inc.20051
+2K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc.200719
+3K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc.201030
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp20123

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199450
199510
199610
199710
199810
199920
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200550
200620
200730
200820
200910
201020
201140
2012150
2013100
2014160
2015110
201690
2017120
201870
2019210
202080
202180
2022120
2023140
2024130
2025160
2026170
FIG. 1 — Lineage of K030055, 1985–2026Source: 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? (5)

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
*K984296Lateralized Intergral Porous Primary Femoral Component
Summary page 1
…21358) De\,ice PrlDduct Code(s): LPH, LZO, MEH Le{ ally Marketed Devices To Which Substantial Equivalence Is Claimed: Lateralized Integral@Femoral Component - K984296 130" Integral@Femoral Component - K984408 Fenning (Osteocap RS@)Femoral Component - K960303 Reach@Femo…
Biomet, Inc.1999—
*K984408130 Modified Integral Femoral Component
Summary page 1
…{ ally Marketed Devices To Which Substantial Equivalence Is Claimed: Lateralized Integral@Femoral Component - K984296 130" Integral@Femoral Component - K984408 Fenning (Osteocap RS@)Femoral Component - K960303 Reach@Femoral Component - K982367, KO00760 Dei Descri…
Biomet, Inc.1999—
*K960303Fenning Femoral Component
Summary page 1
…Claimed: Lateralized Integral@Femoral Component - K984296 130" Integral@Femoral Component - K984408 Fenning (Osteocap RS@)Femoral Component - K960303 Reach@Femoral Component - K982367, KO00760 Dei Description: All devices are metallic, tapered hip femoral compon…
Biomet, Inc.1996—
*K982367Reach Hip Component
Summary page 1
…oral Component - K984296 130" Integral@Femoral Component - K984408 Fenning (Osteocap RS@)Femoral Component - K960303 Reach@Femoral Component - K982367, KO00760 Dei Description: All devices are metallic, tapered hip femoral components. Each utilizes a modular f e r oral he…
Biomet, Inc.1998—
*K000760Reach Femoral ComponentBiomet, Inc.2000—

Also cleared against K984296: 1 other device →

What descends from it? (208)

See all 208

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

NumberDeviceApplicantDecidedDescendants
K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005160
K050124Porous Coated Acetabular ComponentsBiomet, Inc.2005138
K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128
K050251Balance Hip SystemBiomet, Inc.20052
K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc.20061
K042989RX90 Low Profile Acetabular SystemBiomet, Inc.20051

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 21, 2019Class IIZ-0523-2020Environmental controlElevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Apr 16, 2015Class IIIZ-1754-2015Labeling mix-upsBiomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Jan 9, 2015Class IIZ-1122-2015Packaging process controlBiomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
  • 1 of the 15 ancestors has a recall of any class.
  • Of its descendants, K043537 (Biomet, Inc., 2005) has gone furthest, with 160 descendants of its own.
  • 1 other device also cites its predicate K984296.

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?

1) Noninflammatory 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 throchanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5) Revision of previously failed total hip arthoplasty.

Indications for use as stated in the FDA summary.

Also cleared against K984296

1 other device cites the same predicate.

  • K030501X-Series Integral Lateralized Hip ComponentsBiomet, Inc. · 2003

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/K030055 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030055

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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