510(k) Report

510(k) · Cleared

Cleared

Provident II Hip Stem

K190276510(k) SpecialCleared Mar 8, 201928-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

Stelkast, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Mar 8, 2019 as substantially equivalent to K935484 (Stelkast Company, 1994) and 5 other predicates after a 28-day review. Its family tree reaches back 5 generations to 1981. 2 later devices descend from it.

Decided
Mar 8, 2019
Review
28 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K810258 (1981). 13 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1995: 3 other ancestors1994: 2 other ancestors1997: 1 other ancestor2021: 1 descendant cleared2026: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK094035 · Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM · Stelkast Company · 2011K122773 · Cross-Over Acetabular Shell & Liner · Stelkast Company · 2012 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors4 generations back: 2 other ancestors 1 generation forward: 2 descendants K122773 · Cross-Over Acetabular Shell & Liner · Stelkast Company · 2012 · recalledK094035 · Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM · Stelkast Company · 2011K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−50
  1. Root · 5 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 4 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 3 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 2 generations backK094035 Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded…Stelkast Company · 2011
  5. 1 generation backK122773 Cross-Over Acetabular Shell & LinerStelkast Company · 2012 · Recalled
  6. This deviceK190276 Provident II Hip StemStelkast, Inc. · 2019
  7. Descendant · cites it directly · 0 of its ownK254043 TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  8. Descendant · cites it directly · 0 of its ownK201733 Provident II Hip StemsGlobus Medical, Inc. · 2021

Most influential descendants

Showing 2 of 2 · See all
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026 · cites it directly0descendants
  • K201733Provident II Hip StemsGlobus Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−4K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−3K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−2K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company2011—
−1K122773Cross-Over Acetabular Shell & LinerStelkast Company20121
0 (this device)K190276Provident II Hip StemStelkast, Inc.2019—
+1K254043TRIVANCE™ Hip StemGlobus Medical, Inc.2026—
+1K201733Provident II Hip StemsGlobus Medical, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199530
199710
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202610
FIG. 1 — Lineage of K190276, 1981–2026Source: 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? (6)

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
*K935484Provident Hip System
Summary page 6
…tened stem. Predicate Devices: The Provident II Hip Stems are substantially equivalent to the predicate stems of the Provident Hip Stem line (K935484, K946371, K001745, K002796, K094035, K122773), with respect to intended use, materi…
Stelkast Company1994—
*K946371Provident HP System
Summary page 6
…The Provident II Hip Stems are substantially equivalent to the predicate stems of the Provident Hip Stem line (K935484, K946371, K001745, K002796, K094035, K122773), with respect to intended use, materials, design, range of available…
Stelkast Company1995—
*K001745Modification to Provident Hip System
Summary page 6
…rovident II Hip Stems are substantially equivalent to the predicate stems of the Provident Hip Stem line (K935484, K946371, K001745, K002796, K094035, K122773), with respect to intended use, materials, design, range of available sizes, me…
Stelkast Company2000—
*K002796Modification to Provident Hip System
Summary page 6
…II Hip Stems are substantially equivalent to the predicate stems of the Provident Hip Stem line (K935484, K946371, K001745, K002796, K094035, K122773), with respect to intended use, materials, design, range of available sizes, method…
Stelkast Company2000—
*K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM
Summary page 6
…ems are substantially equivalent to the predicate stems of the Provident Hip Stem line (K935484, K946371, K001745, K002796, K094035, K122773), with respect to intended use, materials, design, range of available sizes, method…
Stelkast Company2011—
*K122773Cross-Over Acetabular Shell & Liner
Summary page 6
…ubstantially equivalent to the predicate stems of the Provident Hip Stem line (K935484, K946371, K001745, K002796, K094035, K122773), with respect to intended use, materials, design, range of available sizes, method…
Stelkast Company20121

Also cleared against K935484: 4 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260
K201733Provident II Hip StemsGlobus Medical, Inc.20210

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 38 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
  • 3 of the 13 ancestors have a recall of any class.
  • Of its descendants, K254043 (Globus Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K935484.

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. 2019, this device’s year, is highlighted.

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?

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.

2. Rheumatoid Arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications

Indications for use as stated in the FDA summary.

Also cleared against K935484

4 other devices cite the same predicate.

  • K201733Provident II Hip StemsGlobus Medical, Inc. · 2021
  • K132158Novohip Total Hip SystemNovosource, Inc. · 20141 recall
  • K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company · 2011
  • K073068Accin Hip SystemAccelerated Innovation, LLC · 2008

More from Stelkast, Inc.

3 FDA decisions under this applicant name. See the company

  • K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc. · 2018
  • K162222GENflex2 Total Knee SystemStelkast, Inc. · 2016

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/K190276 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190276: Provident II Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190276

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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