510(k) Report

510(k) · Cleared

Cleared

Acetabular Shells with Mesh Ingrowth Surface

K973163510(k) TraditionalCleared Nov 21, 199788-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

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

Cleared on Nov 21, 1997 as substantially equivalent to K930223 (Howmedica Corp., 1994) and 4 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided
Nov 21, 1997
Review
88 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K930223 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors1998: 1 descendant clearedK930223 · Howmedica Acetabular Shell · Howmedica Corp. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K930223 · Howmedica Acetabular Shell · Howmedica Corp. · 19940
  1. Root · 1 generation backK930223 Howmedica Acetabular ShellHowmedica Corp. · 1994
  2. This deviceK973163 Acetabular Shells with Mesh Ingrowth SurfaceHowmedica Corp. · 1997
  3. Descendant · cites it directly · 0 of its ownK982248 Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and…Howmedica, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K982248Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with…Howmedica, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930223Howmedica Acetabular ShellHowmedica Corp.1994—
0 (this device)K973163Acetabular Shells with Mesh Ingrowth SurfaceHowmedica Corp.1997—
+1K982248Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular…Howmedica, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K973163, 1994–1998Source: 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
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What was it cleared against? (5)

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
*K930223Howmedica Acetabular Shell
Summary page 1
…es is based on an equivalence in intended use, design, materials, manufacturing methods, and indications and contraindications to Howmedica's Vitalock® Solid Back Shells(K930223, K935731, K952397), Vitalock® Cluster Cup(K933102), and Zimmer's Trilogy™ Acetabular Cup(K954698). Mechanical as well as Biologi…
Howmedica Corp.1994—
*K935731Acetabular Shell
Summary page 1
…ed on an equivalence in intended use, design, materials, manufacturing methods, and indications and contraindications to Howmedica's Vitalock® Solid Back Shells(K930223, K935731, K952397), Vitalock® Cluster Cup(K933102), and Zimmer's Trilogy™ Acetabular Cup(K954698). Mechanical as well as Biological testi…
Howmedica Corp.1994—
*K952397Vitalock Solid Backed Acetabular Shell
Summary page 1
…equivalence in intended use, design, materials, manufacturing methods, and indications and contraindications to Howmedica's Vitalock® Solid Back Shells(K930223, K935731, K952397), Vitalock® Cluster Cup(K933102), and Zimmer's Trilogy™ Acetabular Cup(K954698). Mechanical as well as Biological testing was pr…
Howmedica Corp.1995—
*K933102Howmedica Acetabular Shell W/Screw Holes
Summary page 1
…ign, materials, manufacturing methods, and indications and contraindications to Howmedica's Vitalock® Solid Back Shells(K930223, K935731, K952397), Vitalock® Cluster Cup(K933102), and Zimmer's Trilogy™ Acetabular Cup(K954698). Mechanical as well as Biological testing was presented to demonstrate the equiv…
Howmedica Corp.1994—
*K954698Trilogy Acetabular Component 7MM Offset
Summary page 1
…cations and contraindications to Howmedica's Vitalock® Solid Back Shells(K930223, K935731, K952397), Vitalock® Cluster Cup(K933102), and Zimmer's Trilogy™ Acetabular Cup(K954698). Mechanical as well as Biological testing was presented to demonstrate the equivalence of the cast mesh surface to that of a si…
Zimmer, Inc.19961

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K982248Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with…Howmedica, Inc.19980

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K982248 (Howmedica, Inc., 1998) has gone furthest, with 0 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 Acetabular Shells with Mesh Ingrowth Surface are intended to be used for uncemented, primary reconstruction of the acetabular portion of the hip joint during total hip arthroplasty.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Howmedica Corp.

393 FDA decisions under this applicant name. See the company

  • N17004/S013Surgical Simplex P Bone CementHowmedica Corp. · 2000
  • N17004/S012Surgical Simplex P Radiopaque Bone CementHowmedica Corp. · 2000
  • K983528Micro Dynamic MeshHowmedica Corp. · 1998
  • K983404Type 3 Femoral ComponentsHowmedica Corp. · 19981 recall
  • K980925Duration II Tibial Inserts-Ethylene Oxide SterilizationHowmedica Corp. · 1998

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/K973163 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973163: Acetabular Shells with Mesh Ingrowth Surface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973163

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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