510(k) Report

510(k) · Cleared

Cleared

The Implex Hedrocel Modular Elliptical Acetabular Cup

K001039510(k) AbbreviatedCleared Jun 15, 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

Implex Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jun 15, 2000 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 249 later devices descend from it.

Decided
Jun 15, 2000
Review
76 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

249 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2010: 4 descendants cleared2012: 11 descendants cleared2024: 21 descendants cleared2009: 1 descendant cleared2020: 20 descendants cleared2011: 3 descendants cleared2018: 17 descendants cleared2015: 8 descendants cleared2022: 18 descendants cleared2014: 6 descendants cleared2017: 8 descendants cleared2013: 13 descendants cleared2019: 25 descendants cleared2025: 26 descendants cleared2026: 27 descendants cleared2021: 13 descendants cleared2016: 9 descendants cleared2023: 18 descendants cleared200020052010201520202025
  1. This deviceK001039 The Implex Hedrocel Modular Elliptical Acetabular CupImplex Corp. · 2000
  2. Descendant · cites it directly · 248 of its ownK021891 Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 246 of its ownK091508 Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular…Zimmer, Inc. · 2009 · Recalled
  4. Descendant · 3 generations on · 144 of its ownK093846 Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010
  5. Descendant · 3 generations on · 143 of its ownK101229 Longevity IT Highly Crosslinked Polyethylene Elevated Liners…Zimmer, Inc. · 2010
  6. Descendant · 3 generations on · 137 of its ownK103662 Continuum and Trilogy Integrated Taper (IT) Acetabular Systems…Zimmer, Inc. · 2011

Showing 5 of 249 descendants. See all descendants

Descendants cleared per year

2002: 12009: 12010: 42011: 32012: 112013: 132014: 62015: 82016: 92017: 82018: 172019: 252020: 202021: 132022: 182023: 182024: 212025: 262026: 27
2002high 27 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 249 · See all
  • K021891Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. · 2002 · cites it directly248descendants
  • K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc. · 2009 · 2 generations on246descendants
  • K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc. · 2010 · 3 generations on144descendants
  • K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…Zimmer, Inc. · 2010 · 3 generations on143descendants
  • K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Zimmer, Inc. · 2011 · 3 generations on137descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001039The Implex Hedrocel Modular Elliptical Acetabular CupImplex Corp.2000—
+1K021891Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc.20023
+2K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular SystemZimmer, Inc.20093
+3K093846Longevity IT Highly Crosslinked Polyethylene Elevated LinersZimmer, Inc.2010—
+3K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum…Zimmer, Inc.2010—
+3K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT…Zimmer, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200910
201040
201130
2012110
2013130
201460
201580
201690
201780
2018170
2019250
2020200
2021130
2022180
2023180
2024210
2025260
2026270
FIG. 1 — Lineage of K001039, 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 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (249)

See all 249

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

NumberDeviceApplicantDecidedDescendants
K021891Zimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc.2002248

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, K021891 (Zimmer, Inc., 2002) has gone furthest, with 248 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 Implex Corp.

65 FDA decisions under this applicant name. See the company

  • K051978Trabecular Metal Vertebral Body ReplacementImplex Corp. · 2005
  • K051196Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1Implex Corp. · 2005
  • K040487Trabecular Metal Knee System AugmentsImplex Corp. · 20041 recall
  • K040630Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZImplex Corp. · 20042 recalls
  • K040756The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004

Recent decisions in LPH

The LPH category page

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  • 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/K001039 · printed Nov 3, 2026

Cite this page

510(k) Report. “K001039: The Implex Hedrocel Modular Elliptical Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K001039

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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