510(k) Report

510(k) · Cleared

Cleared

The Taper-Fit Total Hip System

K992234510(k) TraditionalCleared Nov 10, 1999131-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

Corin USA · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

Cleared on Nov 10, 1999 after a 131-day review. The FDA summary names no predicate by number. 119 later devices descend from it.

Decided
Nov 10, 1999
Review
131 days
Class
Class II
Product code
JDG
Recalls
None
Predicates
0

119 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2021: 6 descendants cleared2016: 5 descendants cleared2001: 1 descendant cleared2011: 3 descendants cleared2012: 5 descendants cleared2010: 1 descendant cleared2024: 7 descendants cleared2018: 10 descendants cleared2013: 12 descendants cleared2019: 9 descendants cleared2014: 1 descendant cleared2022: 9 descendants cleared2017: 6 descendants cleared2026: 10 descendants cleared2023: 10 descendants cleared2020: 10 descendants cleared2025: 12 descendants cleared1995200020052010201520202025
  1. This deviceK992234 The Taper-Fit Total Hip SystemCorin USA · 1999
  2. Descendant · cites it directly · 118 of its ownK003666 Taper-Fit Total Hip SystemCorin USA · 2001
  3. Descendant · 2 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
  4. Descendant · 3 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  5. Descendant · 2 generations on · 62 of its ownK111911 Corin Optimom Modular HeadCorin USA · 2011
  6. Descendant · 2 generations on · 61 of its ownK120362 Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012

Showing 5 of 119 descendants. See all descendants

Descendants cleared per year

2001: 12010: 12011: 32012: 52013: 122014: 12015: 22016: 52017: 62018: 102019: 92020: 102021: 62022: 92023: 102024: 72025: 122026: 10
2001high 12 (2013) · low 0 (2002)2026

Most influential descendants

Showing 5 of 119 · See all
  • K003666Taper-Fit Total Hip SystemCorin USA · 2001 · cites it directly118descendants
  • K093472Trinity Acetabular SystemCorin USA · 2010 · 2 generations on117descendants
  • K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 3 generations on109descendants
  • K111911Corin Optimom Modular HeadCorin USA · 2011 · 2 generations on62descendants
  • K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA · 2012 · 2 generations on61descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992234The Taper-Fit Total Hip SystemCorin USA1999—
+1K003666Taper-Fit Total Hip SystemCorin USA2001—
+2K093472Trinity Acetabular SystemCorin USA20101
+3K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
+2K111911Corin Optimom Modular HeadCorin USA2011—
+2K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
201010
201130
201250
2013120
201410
201520
201650
201760
2018100
201990
2020100
202160
202290
2023100
202470
2025120
2026100
FIG. 1 — Lineage of K992234, 1999–2026Source: 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), 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 JDG? 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 JDG device

  1. #1 K212431 Biomet Answer/Impact/Integral Distal…score 3.1 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (119)

See all 119

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

NumberDeviceApplicantDecidedDescendants
K003666Taper-Fit Total Hip SystemCorin USA2001118
K142761Corin TaperFit Hip StemCorin USA20154
K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163
K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212

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, K003666 (Corin USA, 2001) has gone furthest, with 118 descendants of its own.

How does its category compare?

All JDG devices

JDG Prosthesis, Hip, Femoral Component, Cemented, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDG

1in 2022

2018: 12020: 12022: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDG

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

Recalls per year · JDG

4in 2021

2009: 22013: 32021: 4
2007high 4 (2021) · low 0 (2007)2026

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

Adverse event reports per year · JDG

263in 2025

2007: 282008: 192009: 382010: 372011: 252012: 492013: 842014: 1452015: 3912016: 3832017: 3282018: 4472019: 3332020: 1,0462021: 1,2062022: 8862023: 2892024: 3002025: 263
2007high 1,206 (2021) · low 19 (2008)2025

MAUDE reports naming product code JDG, 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
20070—028
20080—019
20090—238
20100—037
20110—025
20120—049
20130—384
20140—0145
20150—0391
20160—0383
20170—0328
20181—0447
20190—0333
20201—01,046
20210—41,206
20221—0886
20230—0289
20240—0300
20250—0263
20260—0—

What is it indicated for?

Relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, post-trauma disease, avascular necrosis, and total hip revision.

These femoral stems are intended for use with bone cement.

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

Cite this page

510(k) Report. “K992234: The Taper-Fit Total 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/K992234

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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