510(k) Report

510(k) · Cleared

Cleared

Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3

K042871510(k) SpecialCleared Dec 21, 200464-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

Zimmer Trabecular · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Dec 21, 2004 after a 64-day review. The FDA summary names no predicate by number. 80 later devices descend from it.

Decided
Dec 21, 2004
Review
64 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2024: 11 descendants cleared2025: 18 descendants cleared2011: 1 descendant cleared2018: 5 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2022: 7 descendants cleared2020: 10 descendants cleared2026: 8 descendants cleared2016: 2 descendants cleared2019: 4 descendants cleared2017: 1 descendant cleared2021: 3 descendants cleared2023: 5 descendants cleared200020052010201520202025
  1. This deviceK042871 Trabecular Metal Acetabular Augments, Models 4894-XXX-YY…Zimmer Trabecular · 2004
  2. Descendant · cites it directly · 79 of its ownK061067 Trabecular Metal Acetabular AugmentsZimmer Trabecular · 2006 · Recalled
  3. Descendant · cites it directly · 53 of its ownK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
  4. Descendant · 2 generations on · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
  5. Descendant · 3 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
  6. Descendant · 2 generations on · 21 of its ownK102019 Restoration Acetabular Wedge AugmentsHowmedica Osteonics · 2011 · Recalled

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2006: 12010: 12011: 12012: 12013: 12015: 12016: 22017: 12018: 52019: 42020: 102021: 32022: 72023: 52024: 112025: 182026: 8
2006high 18 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 80 · See all
  • K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular · 2006 · cites it directly79descendants
  • K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010 · cites it directly53descendants
  • K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · 2 generations on40descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 3 generations on24descendants
  • K102019Restoration Acetabular Wedge AugmentsHowmedica Osteonics · 2011 · 2 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042871Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3…Zimmer Trabecular2004—
+1K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular20064
+1K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.2010—
+2K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics20151
+3K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171
+2K102019Restoration Acetabular Wedge AugmentsHowmedica Osteonics20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201010
201110
201210
201310
201510
201620
201710
201850
201940
2020100
202130
202270
202350
2024110
2025180
202680
FIG. 1 — Lineage of K042871, 2004–2026Source: 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 24.3 · 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?

The FDA summary names no predicate by number.

What descends from it? (80)

See all 80

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

NumberDeviceApplicantDecidedDescendants
K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular200679
K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053
K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242
K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122

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, K061067 (Zimmer Trabecular, 2006) has gone furthest, with 79 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—

What is it indicated for?

Trabecular Metal Acetabular Augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

Indications for use as stated in the FDA summary.

More from Zimmer Trabecular

10 FDA decisions under this applicant name. See the company

  • K061155Vista P Vertebral Body Replacement SystemZimmer Trabecular · 2006
  • K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular · 20064 recalls
  • K053340Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
  • K052950The Zimmer TMT Trabecular Metal Vertebral Body Replacement SystemZimmer Trabecular · 2005
  • K051756Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZZimmer Trabecular · 2005

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/K042871 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042871: Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042871

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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