510(k) Report

510(k) · Cleared

Cleared

Opti-Fix Collared Femoral Components

K874868510(k) TraditionalCleared Jan 26, 198860-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

Richards Medical Co., Inc. · JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

Cleared on Jan 26, 1988 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 26, 1988
Review
60 days
Class
Class II
Product code
JDG
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared1990200020102020
  1. This deviceK874868 Opti-Fix Collared Femoral ComponentsRichards Medical Co., Inc. · 1988
  2. Descendant · cites it directly · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K874868Opti-Fix Collared Femoral ComponentsRichards Medical Co., Inc.1988—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K874868, 1988–2013Source: 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 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?

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

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20130

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, K123598 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 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—

More from Richards Medical Co., Inc.

71 FDA decisions under this applicant name. See the company

  • K896106Rogozinski Spinal System, Add'l ComponentsRichards Medical Co., Inc. · 1990
  • K900628Modular Hip SystemRichards Medical Co., Inc. · 1990
  • K896580Uni-Polar HeadRichards Medical Co., Inc. · 1990
  • K895241Intramedullary Hip ScrewRichards Medical Co., Inc. · 1990
  • K884824Tricon-M Total Knee SystemRichards Medical Co., Inc. · 1989

Recent decisions in JDG

The JDG category page

  • K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc. · 2022
  • K193546Distal CentralizersBiomet, Inc. · 2020
  • K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker Orthopaedics · 20182 recalls
  • K001984Progeny Forged Cocr Cemented Femoral ComponentStelkast Company · 2000
  • K992234The Taper-Fit Total Hip SystemCorin USA · 1999

https://510kreport.com/device/K874868 · printed Nov 4, 2026

Cite this page

510(k) Report. “K874868: Opti-Fix Collared Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874868

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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