510(k) Report

510(k) · Cleared

Cleared

Trabecular Metal Acetabular Revision Shells

K050937510(k) SpecialCleared May 11, 200527-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 May 11, 2005 after a 27-day review. The FDA summary names no predicate by number. 14 later devices descend from it.

Decided
May 11, 2005
Review
27 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2026: 1 descendant cleared2018: 2 descendants cleared2022: 2 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2023: 2 descendants cleared2024: 2 descendants cleared20052010201520202025
  1. This deviceK050937 Trabecular Metal Acetabular Revision ShellsZimmer Trabecular · 2005
  2. Descendant · cites it directly · 13 of its ownK150790 REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc. · 2015
  3. Descendant · 2 generations on · 5 of its ownK171073 Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017
  4. Descendant · 2 generations on · 4 of its ownK182109 REDAPT Modular Acetabular ShellSmith & Nephew, Inc. · 2018
  5. Descendant · 2 generations on · 4 of its ownK160923 REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. · 2016
  6. Descendant · 2 generations on · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2015: 12016: 12017: 12018: 22019: 12022: 22023: 22024: 22025: 12026: 1
2015high 2 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 14 · See all
  • K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc. · 2015 · cites it directly13descendants
  • K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017 · 2 generations on5descendants
  • K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc. · 2018 · 2 generations on4descendants
  • K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. · 2016 · 2 generations on4descendants
  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050937Trabecular Metal Acetabular Revision ShellsZimmer Trabecular2005—
+1K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.2015—
+2K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc.2017—
+2K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.2018—
+2K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.2016—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20221

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
201710
201820
201910
202220
202320
202420
202510
202610
FIG. 1 — Lineage of K050937, 2005–2026Source: 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 24.2 · 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?

The FDA summary names no predicate by number.

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.201513
K253630Mpact 3D Metal FoamMedacta International S.A.20260

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, K150790 (Smith & Nephew, Inc., 2015) has gone furthest, with 13 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?

The Indications for Use of the Trabecular Metal Acetabular Revision Shells are:

For cemented or cementless use.

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis.

Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results.

Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

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/K050937 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050937: Trabecular Metal Acetabular Revision Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050937

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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