510(k) Report

510(k) · Cleared

Cleared

Fenning Femoral Component

K960303510(k) TraditionalCleared Jun 21, 1996151-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 Jun 21, 1996 as substantially equivalent to K922500 (Biopro, Inc., 1994) and 2 other predicates after a 151-day review. Its family tree reaches back 1 generation to 1985. 209 later devices descend from it.

Decided
Jun 21, 1996
Review
151 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K854046 (1985). 3 ancestors in all. 209 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1986: 1 other ancestor2003: 1 descendant cleared2012: 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. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 27 descendants4 generations forward: 65 descendants5 generations forward: 45 descendants6 generations forward: 36 descendants7 generations forward: 18 descendants8 generations forward: 5 descendants9 generations forward: 4 descendants10 generations forward: 2 descendants K854046 · Conical Collar Hip Prosthesis · Kirschner Medical Corp. · 19850+5+10
  1. Root · 1 generation backK854046 Conical Collar Hip ProsthesisKirschner Medical Corp. · 1985
  2. This deviceK960303 Fenning Femoral ComponentBiomet, Inc. · 1996
  3. Descendant · cites it directly · 208 of its ownK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
  4. Descendant · 2 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  5. Descendant · 2 generations on · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
  6. Descendant · 3 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
  7. Descendant · 4 generations on · 65 of its ownK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · Recalled

Showing 5 of 209 descendants. See all descendants

Descendants cleared per year

2003: 12005: 52006: 22007: 32008: 22009: 12010: 22011: 42012: 152013: 102014: 162015: 112016: 92017: 122018: 72019: 212020: 82021: 82022: 122023: 142024: 132025: 162026: 17
2003high 21 (2019) · low 0 (2004)2026

Most influential descendants

Showing 5 of 209 · See all
  • K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc. · 2003 · cites it directly208descendants
  • K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 2 generations on160descendants
  • K050124Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · 2 generations on138descendants
  • K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · 3 generations on137descendants
  • K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · 4 generations on65descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K854046Conical Collar Hip ProsthesisKirschner Medical Corp.1985—
0 (this device)K960303Fenning Femoral ComponentBiomet, Inc.1996—
+1K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric…Biomet, Inc.20033
+2K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
+2K050124Porous Coated Acetabular ComponentsBiomet, Inc.20051
+3K070369Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc.200719
+4K093235Ringloc + Hybrid Acetabular SystemBiomet, Inc.201030

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
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 K960303, 1985–2026Source: 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), 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 24.3 · 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? (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
*K922500PSL Total Hip Replacement System
Summary page 2
…ction and overall design Biomet's Fenning Femoral Component is equivalent to almost all hip components on the market. These stems include: PSL Total Hip (BioPro) 510(k) K922500 Conical Collar Hip (Kirschner) 510(k) K854046 C.Osteocap Hip (Kirschner) 510(k) K861450 GO00350
Biopro, Inc.1994—
*K854046Conical Collar Hip Prosthesis
Summary page 2
…al Component is equivalent to almost all hip components on the market. These stems include: PSL Total Hip (BioPro) 510(k) K922500 Conical Collar Hip (Kirschner) 510(k) K854046 C.Osteocap Hip (Kirschner) 510(k) K861450 GO00350
Kirschner Medical Corp.1985—
*K861450Schurman/Carter Hip Prosthesis Porous Coated
Summary page 2
…ip components on the market. These stems include: PSL Total Hip (BioPro) 510(k) K922500 Conical Collar Hip (Kirschner) 510(k) K854046 C.Osteocap Hip (Kirschner) 510(k) K861450 GO00350
Kirschner Medical Corp.1986—

What descends from it? (209)

See all 209

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

NumberDeviceApplicantDecidedDescendants
K030055Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral…Biomet, Inc.2003208

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K030055 (Biomet, Inc., 2003) has gone furthest, with 208 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, 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/K960303 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960303: Fenning Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960303

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026