510(k) Report

510(k) · Cleared

Cleared

Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-a

K982248510(k) TraditionalCleared Aug 31, 199866-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, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Aug 31, 1998 as substantially equivalent to K971206 (Howmedica Corp., 1998) and 4 other predicates after a 66-day review. Its family tree reaches back 2 generations to 1994.

Decided
Aug 31, 1998
Review
66 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K930223 (1994). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1996: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestorsK930223 · Howmedica Acetabular Shell · Howmedica Corp. · 1994K973163 · Acetabular Shells with Mesh Ingrowth Surface · Howmedica Corp. · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors K973163 · Acetabular Shells with Mesh Ingrowth Surface · Howmedica Corp. · 1997K930223 · Howmedica Acetabular Shell · Howmedica Corp. · 19940
  1. Root · 2 generations backK930223 Howmedica Acetabular ShellHowmedica Corp. · 1994
  2. 1 generation backK973163 Acetabular Shells with Mesh Ingrowth SurfaceHowmedica Corp. · 1997
  3. This deviceK982248 Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and…Howmedica, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K930223Howmedica Acetabular ShellHowmedica Corp.1994—
−1K973163Acetabular Shells with Mesh Ingrowth SurfaceHowmedica Corp.1997—
0 (this device)K982248Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular…Howmedica, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199520
199620
199810
FIG. 1 — Lineage of K982248, 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 24.3 · 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? (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
*K971206Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating
Summary page 1
…thin layer of hydroxyapatite coating applied to the porous coated surface. The Peri-Apatite™ coating is the same coating previously characterized and cleared in 510(k) K971206. The substantial equivalence of these devices is based on an equivalence in intended use, materials, design, and relative indica…
Howmedica Corp.19981
*K955871Howmedica Asymmetric Stem Femoral Component
Summary page 1
…gn, and relative indications and contraindications to Howmedica's Meridian® ST Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating (K971206), Asymmetric Stem (K955871), Vitalock® Cluster Shell (K933102), Vitalock® Spiked Shell (K953664), and Mesh Ingrowth Shells (K373163). SERViC…
Howmedica Corp.19961
*K933102Howmedica Acetabular Shell W/Screw Holes
Summary page 1
…ntraindications to Howmedica's Meridian® ST Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating (K971206), Asymmetric Stem (K955871), Vitalock® Cluster Shell (K933102), Vitalock® Spiked Shell (K953664), and Mesh Ingrowth Shells (K373163). SERViCy *p\ 5., & \d g 3 = k3 %, s,…
Howmedica Corp.1994—
*K953664Vitalock Spiked Acetabular Shell
Summary page 1
…idian® ST Stem and Vitalock® Solid Back Shell with Peri-Apatite™ Coating (K971206), Asymmetric Stem (K955871), Vitalock® Cluster Shell (K933102), Vitalock® Spiked Shell (K953664), and Mesh Ingrowth Shells (K373163). SERViCy *p\ 5., & \d g 3 = k3 %, s, . vera % C DEPARTMENT OF HEALTH…
Howmedica Corp.1995—
*K973163Acetabular Shells with Mesh Ingrowth Surface
Our OCR of the scanned summary read K373163, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mesh Ingrowth Shells”.
Howmedica Corp.1997—

Also cleared against K971206: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
  • 3 of the 9 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K971206.

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 Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Mesh Ingrowth Shells with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum, respectively.

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

Also cleared against K971206

4 other devices cite the same predicate.

  • K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
  • K101072Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-ApatiteHowmedica Osteonics Corp. · 2011
  • K023302Echelon Porous Plus HA Hip StemsSmith & Nephew, Inc. · 2002
  • K013475Trident Porous Titanium Acetabular Component with Peri-Apatite CoatingHowmedica Osteonics Corp. · 2001

More from Howmedica, Inc.

36 FDA decisions under this applicant name. See the company

  • K984251Xia Spine SystemHowmedica, Inc. · 1999
  • K984202Howmedica Humeral Intercalary SystemHowmedica, Inc. · 1999
  • K984305Zeta Multizone Locking Nail SystemHowmedica, Inc. · 1999
  • K983885Burr Hole Covers, Craniomaxillofacial PlatesHowmedica, Inc. · 1999
  • K983358G/K SFN and STN Locking NailsHowmedica, Inc. · 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/K982248 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982248: Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982248

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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