Cleared Traditional

SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL (K831884) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831884 · Richards Manufacturer Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K831884.
GALANTE FIBER METAL TOTAL HIP
K833912 · Zimmer, Inc. · Dec 1983
FREEMAN ACETABULAR CUP
K832958 · Depuy, Inc. · Oct 1983
MMS ACETABULAR CUPS
K830361 · 3M Company · Sep 1983
P.C.A. HIP SYSTEM
K831373 · Howmedica Corp. · Aug 1983
INTERFERENCE MEDULLARY FIT -IMF-HIP
K831314 · Depuy, Inc. · Jul 1983
MILWAUKEE AUSTIN MOORE TOTAL HIP
K830314 · Biomet, Inc. · Jun 1983