510(k) · Cleared

Cleared

Provident Hip System

K935484510(k) TraditionalCleared Jun 6, 1994203-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 Company · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jun 6, 1994 after a 203-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 95 later devices descend from it.

Decided: Jun 6, 1994
Review: 203 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 0

95 later devices descend from it, 5 citing it directly.

This deviceK935484 Provident Hip SystemStelkast Company · 1994
Descendant · cites it directly · 79 of its ownK094035 Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded…Stelkast Company · 2011
Descendant · 2 generations on · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
Descendant · cites it directly · 28 of its ownK073068 Accin Hip SystemAccelerated Innovation, LLC · 2008
Descendant · 2 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
Descendant · 3 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

2008high 10 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 95 · See all

K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company · 2011 · cites it directly79descendants
K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · 2 generations on53descendants
K073068Accin Hip SystemAccelerated Innovation, LLC · 2008 · cites it directly28descendants
K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 2 generations on25descendants
K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 3 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935484	Provident Hip System	Stelkast Company	1994	—
+1	K094035	Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM	Stelkast Company	2011	—
+2	K112802	Pipeline Total Hip System	Pipeline Orthopedics	2012	—
+1	K073068	Accin Hip System	Accelerated Innovation, LLC	2008	—
+2	K100445	Klassic HD Hip System	Total Joint Orthopedics, Inc.	2010	—
+3	K122158	PBP Total Hip System	Pipeline Biomedical Products, LLC	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	3	0
2011	1	0
2012	4	0
2013	6	0
2014	8	0
2015	5	0
2016	4	0
2017	6	0
2018	3	0
2019	8	0
2020	3	0
2021	6	0
2022	10	0
2023	10	0
2024	5	0
2025	5	0
2026	7	0

FIG. 1 — Lineage of K935484, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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? (95)

See all 95

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

Number	Device	Applicant	Decided	Descendants
K094035	Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM	Stelkast Company	2011	79
K073068	Accin Hip System	Accelerated Innovation, LLC	2008	28
K132158	Novohip Total Hip System	Novosource, Inc.	2014	6
K190276	Provident II Hip Stem	Stelkast, Inc.	2019	2
K201733	Provident II Hip Stems	Globus Medical, Inc.	2021	0

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, K094035 (Stelkast Company, 2011) has gone furthest, with 79 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

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

https://510kreport.com/device/K935484 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935484: Provident Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935484

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Record history

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