510(k) Report

510(k) · Cleared

Recalled · 2010

Trabecular Metal Acetabular Augments

K061067510(k) TraditionalCleared May 25, 200638-day reviewClass II21 CFR 888.3358Recalls 4

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 May 25, 2006 as substantially equivalent to K042871 (Zimmer Trabecular, 2004) and 2 other predicates after a 38-day review. Its family tree reaches back 1 generation to 2000. 79 later devices descend from it. It has been recalled 4 times.

Decided
May 25, 2006
Review
38 days
Class
Class II
Product code
LPH
Recalls
4
Predicates
3

Its longest line of descent runs back 1 generation to K001471 (2000). 3 ancestors in all. 79 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 1 other ancestor2010: 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 cleared2016: 2 descendants cleared2020: 10 descendants cleared2026: 8 descendants cleared2019: 4 descendants cleared2017: 1 descendant cleared2021: 3 descendants cleared2023: 5 descendants clearedK001471 · The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ · Implex Corp. · 2000200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 5 descendants2 generations forward: 9 descendants3 generations forward: 20 descendants4 generations forward: 29 descendants5 generations forward: 12 descendants6 generations forward: 4 descendants K001471 · The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ · Implex Corp. · 20000+5
  1. Root · 1 generation backK001471 The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZImplex Corp. · 2000
  2. This deviceK061067 Trabecular Metal Acetabular AugmentsZimmer Trabecular · 2006
  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 · cites it directly · 21 of its ownK102019 Restoration Acetabular Wedge AugmentsHowmedica Osteonics · 2011 · Recalled
  7. Descendant · 2 generations on · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 12013: 12015: 12016: 22017: 12018: 52019: 42020: 102021: 32022: 72023: 52024: 112025: 182026: 8
2010high 18 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 79 · See all
  • 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 · cites it directly21descendants
  • K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · 2 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001471The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZImplex Corp.2000—
0 (this device)K061067Trabecular Metal Acetabular AugmentsZimmer Trabecular2006—
+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
+1K102019Restoration Acetabular Wedge AugmentsHowmedica Osteonics20111
+2K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics20161

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201210
201310
201510
201620
201710
201850
201940
2020100
202130
202270
202350
2024110
2025180
202680
FIG. 1 — Lineage of K061067, 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), 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
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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
*K042871Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3…
Summary page 2
…vices: The predicated devices for which substantial equivalence has been documented herein are: K042871 - Trabecular Metal Acetabular Augments (12/31/04, Zimmer TMT)…
Zimmer Trabecular2004—
*K012507The Trabecular Metal Technology Acetabular Augment System, Models 4893-XX-YY (Zimmer)…
Summary page 2
…K042871 - Trabecular Metal Acetabular Augments (12/31/04, Zimmer TMT) K012507 - The Trabecular Metal Technology Acetabufar Augment System (8/30/01, Implex Corp.)…
Implex Corp.2001—
*K001471The Implex Hedrocel Acetabular Augment, XX-Yyy-ZZZZ
Summary page 2
…K012507 - The Trabecular Metal Technology Acetabufar Augment System (8/30/01, Implex Corp.) K001471 - The Implex Hedrocel Acetabular Augment System (8/7/00, Implex Corp.) Conclusion:…
Implex Corp.2000—

Also cleared against K042871: 3 other devices →

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc.201053
K102019Restoration Acetabular Wedge AugmentsHowmedica Osteonics201121
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
K251718ArTT Augments and Buttresses and Bone ScrewsLima Corporate S.P.A.20250

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 6, 2010Not classifiedZ-2214-2010PackagingThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Apr 6, 2010Not classifiedZ-2215-2010PackagingThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Apr 6, 2010Not classifiedZ-2216-2010PackagingThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
Apr 6, 2010Not classifiedZ-2217-2010PackagingThe firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.

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, K100391 (DePuy Orthopaedics, Inc., 2010) has gone furthest, with 53 descendants of its own.
  • 3 other devices also cite its predicate K042871.

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.

Also cleared against K042871

3 other devices cite the same predicate.

  • K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG · 2024
  • K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc. · 2012
  • K100391Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010

More from Zimmer Trabecular

10 FDA decisions under this applicant name. See the company

  • K061155Vista P Vertebral Body Replacement SystemZimmer Trabecular · 2006
  • 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
  • K050766Explant Osteonecrosis Intervention Implant Removal SystemZimmer 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/K061067 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061067: Trabecular Metal Acetabular Augments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061067

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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