510(k) Report

510(k) · Cleared

Cleared

Modification to Provident Hip System

K001745510(k) SpecialCleared Jul 27, 200049-day reviewClass II21 CFR 888.3360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stelkast Company · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Jul 27, 2000 after a 49-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 36 later devices descend from it.

Decided
Jul 27, 2000
Review
49 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

36 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2012: 1 descendant cleared2008: 1 descendant cleared2010: 3 descendants cleared2022: 4 descendants cleared2013: 1 descendant cleared2021: 3 descendants cleared2026: 4 descendants cleared2015: 2 descendants cleared2014: 4 descendants cleared2016: 1 descendant cleared2018: 2 descendants cleared2017: 3 descendants cleared2025: 2 descendants cleared2023: 2 descendants cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK001745 Modification to Provident Hip SystemStelkast Company · 2000
  2. Descendant · cites it directly · 28 of its ownK073068 Accin Hip SystemAccelerated Innovation, LLC · 2008
  3. Descendant · 2 generations on · 25 of its ownK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
  4. Descendant · 3 generations on · 16 of its ownK143407 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014
  5. Descendant · 3 generations on · 14 of its ownK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
  6. Descendant · 4 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2008: 12010: 32012: 12013: 12014: 42015: 22016: 12017: 32018: 22019: 22021: 32022: 42023: 22024: 12025: 22026: 4
2008high 4 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 36 · See all
  • K073068Accin Hip SystemAccelerated Innovation, LLC · 2008 · cites it directly28descendants
  • K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010 · 2 generations on25descendants
  • K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2014 · 3 generations on16descendants
  • K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014 · 3 generations on14descendants
  • K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001745Modification to Provident Hip SystemStelkast Company2000—
+1K073068Accin Hip SystemAccelerated Innovation, LLC2008—
+2K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.2010—
+3K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.2014—
+3K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.2014—
+4K163577Ecofit® Hip SystemImplantcast GmbH20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201030
201210
201310
201440
201520
201610
201730
201820
201920
202130
202240
202320
202410
202520
202640
FIG. 1 — Lineage of K001745, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K073068Accin Hip SystemAccelerated Innovation, LLC200828
K122773Cross-Over Acetabular Shell & LinerStelkast Company20126
K190276Provident II Hip StemStelkast, Inc.20192

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, K073068 (Accelerated Innovation, LLC, 2008) has gone furthest, with 28 descendants of its own.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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
20072—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—
Cite this page

510(k) Report. “K001745: Modification to Provident Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001745

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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