Cleared Traditional

K831884 - SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL

K831884 is an FDA 510(k) clearance for SPECTRON EXTRA-SMALL, manufactured by Richards Manufacturer Co.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K831884 · Richards Manufacturer Co. · Orthopedic device
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Sep 1983
Decision
99d
Days
Class 2
Risk

K831884 is an FDA 510(k) clearance for the SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Richards Manufacturer Co. (Memphis, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 99 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 Manufacturer Co. devices

FDA 510(k) Submission Details - K831884

510(k) Number K831884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date September 20, 1983
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
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 522
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K831884.
FREEMAN ACETABULAR CUP
K832958 · Depuy, Inc. · Oct 1983
MMS ACETABULAR CUPS
K830361 · 3M Company · Sep 1983
DOSIMETRIC RELEASE OF GAMMA RADIATION
K832211 · Kirschner Medical Corp. · Sep 1983
P.C.A. HIP SYSTEM
K831373 · Howmedica Corp. · Aug 1983
METAL-BACKED ACE TABULAR CUP
K831986 · Kirschner Medical Corp. · Aug 1983
INTERFERENCE MEDULLARY FIT -IMF-HIP
K831314 · Depuy, Inc. · Jul 1983