510(k) Report

510(k) · Cleared

Cleared

Vitalock Solid Backed Acetabular Shell

K952397510(k) TraditionalCleared Jul 21, 199560-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 Jul 21, 1995 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 219 later devices descend from it.

Decided
Jul 21, 1995
Review
60 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared2000: 3 descendants cleared1998: 1 descendant cleared2016: 6 descendants cleared2018: 13 descendants cleared2006: 2 descendants cleared2001: 2 descendants cleared2013: 10 descendants cleared2007: 3 descendants cleared2009: 4 descendants cleared2008: 6 descendants cleared2015: 6 descendants cleared2004: 1 descendant cleared2026: 16 descendants cleared2023: 13 descendants cleared2024: 18 descendants cleared2019: 11 descendants cleared2017: 13 descendants cleared2014: 7 descendants cleared2011: 9 descendants cleared2012: 7 descendants cleared2010: 3 descendants cleared2022: 16 descendants cleared2021: 14 descendants cleared2020: 8 descendants cleared2025: 25 descendants cleared1995200020052010201520202025
  1. This deviceK952397 Vitalock Solid Backed Acetabular ShellHowmedica Corp. · 1995
  2. Descendant · cites it directly · 216 of its ownK971854 Osteolock Acetabular Shell SystemHowmedica Corp. · 1997
  3. Descendant · 2 generations on · 150 of its ownK001448 Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000
  4. Descendant · 3 generations on · 90 of its ownK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  5. Descendant · 4 generations on · 83 of its ownK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  6. Descendant · 2 generations on · 69 of its ownK001449 Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000

Showing 5 of 219 descendants. See all descendants

Descendants cleared per year

1997: 21998: 12000: 32001: 22004: 12006: 22007: 32008: 62009: 42010: 32011: 92012: 72013: 102014: 72015: 62016: 62017: 132018: 132019: 112020: 82021: 142022: 162023: 132024: 182025: 252026: 16
1997high 25 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 219 · See all
  • K971854Osteolock Acetabular Shell SystemHowmedica Corp. · 1997 · cites it directly216descendants
  • K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp. · 2000 · 2 generations on150descendants
  • K060437Excia Total Hip System with U-CapAesculap, Inc. · 2006 · 3 generations on90descendants
  • K080584Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008 · 4 generations on83descendants
  • K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp. · 2000 · 2 generations on69descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952397Vitalock Solid Backed Acetabular ShellHowmedica Corp.1995—
+1K971854Osteolock Acetabular Shell SystemHowmedica Corp.1997—
+2K001448Trident Acetabular Shells: PS-HAHowmedica Osteonics Corp.2000—
+3K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
+4K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—
+2K001449Trident Acetabular Shells: PSHowmedica Osteonics Corp.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
200030
200120
200410
200620
200730
200860
200940
201030
201190
201270
2013100
201470
201560
201660
2017130
2018130
2019110
202080
2021140
2022160
2023130
2024180
2025250
2026160
FIG. 1 — Lineage of K952397, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (219)

See all 219

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

NumberDeviceApplicantDecidedDescendants
K971854Osteolock Acetabular Shell SystemHowmedica Corp.1997216
K973163Acetabular Shells with Mesh Ingrowth SurfaceHowmedica Corp.19971

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, K971854 (Howmedica Corp., 1997) has gone furthest, with 216 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—

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/K952397 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952397: Vitalock Solid Backed Acetabular Shell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952397

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026