510(k) Report

510(k) · Cleared

Cleared

Reach Femoral Component

K000760510(k) TraditionalCleared May 23, 200076-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 May 23, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 238 later devices descend from it.

Decided
May 23, 2000
Review
76 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

238 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2015: 14 descendants cleared2003: 2 descendants cleared2004: 1 descendant cleared2012: 17 descendants cleared2005: 6 descendants cleared2006: 2 descendants cleared2009: 2 descendants cleared2013: 12 descendants cleared2011: 4 descendants cleared2019: 23 descendants cleared2008: 2 descendants cleared2014: 16 descendants cleared2016: 11 descendants cleared2010: 4 descendants cleared2025: 19 descendants cleared2017: 15 descendants cleared2022: 14 descendants cleared2026: 18 descendants cleared2020: 9 descendants cleared2023: 14 descendants cleared2024: 13 descendants cleared2018: 7 descendants cleared2021: 9 descendants cleared200020052010201520202025
  1. This deviceK000760 Reach Femoral ComponentBiomet, Inc. · 2000
  2. Descendant · cites it directly · 208 of its ownK030055 Mallory/Head Total Hip System; HA Mallory/Head Total Hip System…Biomet, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  4. Descendant · 2 generations on · 138 of its ownK050124 Porous Coated Acetabular ComponentsBiomet, Inc. · 2005 · Recalled
  5. Descendant · 3 generations on · 137 of its ownK070369 Regenerx Ringloc + Modular Acetabular ShellsBiomet, Inc. · 2007 · Recalled
  6. Descendant · 4 generations on · 65 of its ownK093235 Ringloc + Hybrid Acetabular SystemBiomet, Inc. · 2010 · Recalled

Showing 5 of 238 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12005: 62006: 22007: 42008: 22009: 22010: 42011: 42012: 172013: 122014: 162015: 142016: 112017: 152018: 72019: 232020: 92021: 92022: 142023: 142024: 132025: 192026: 18
2003high 23 (2019) · low 1 (2004)2026

Most influential descendants

Showing 5 of 238 · 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
0 (this device)K000760Reach Femoral ComponentBiomet, Inc.2000—
+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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
200560
200620
200740
200820
200920
201040
201140
2012170
2013120
2014160
2015140
2016110
2017150
201870
2019230
202090
202190
2022140
2023140
2024130
2025190
2026180
FIG. 1 — Lineage of K000760, 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? (238)

See all 238

5 later devices cite 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
K031693Mallory/Head Modular Calcar with and Without HABiomet, Inc.200339
K062978U2 Hip Stem, TI Plasma SprayUnited Orthopedic Corp.20071
K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041
K151603Arcos One-piece Femoral Revision SystemBiomet, Inc.20150

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, 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/K000760 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000760: Reach Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000760

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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