Cleared Traditional

K874619 - SPECTRON EF ACETABULAR COMPONENT

K874619 is an FDA 510(k) clearance for SPECTRON EF ACETABULAR COMPONENT, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K874619 · Richards Medical Co., Inc. · Orthopedic device
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Feb 1988
Decision
100d
Days
Class 2
Risk

K874619 is an FDA 510(k) clearance for the SPECTRON EF ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on February 17, 1988 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K874619

510(k) Number K874619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date February 17, 1988
Days to Decision 100 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 122d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K874619.
TITANIUM FEMORAL HIP
K881128 · Depuy, Inc. · Mar 1988
PERFECTA TOTAL HIP SYSTEM
K880461 · Orthomet, Inc. · Mar 1988
TOWNLEY COX COMB ACETABULAR CUP
K880004 · Orthomet, Inc. · Feb 1988
MOORE HIP PROSTHESIS SOLID STEM
K874599 · Orthopedic Systems, Inc. · Jan 1988
MOORE HIP PROSTHESIS FENESTRATED STEM
K874616 · Orthopedic Systems, Inc. · Jan 1988
SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
K874093 · Protek, Inc. · Jan 1988