Cleared Traditional

K823727 - SPECTRON PRIMARY STEM FEMORAL PROSTHES

K823727 is an FDA 510(k) clearance for SPECTRON PRIMARY STEM FEMORAL PROSTHES, manufactured by Richard'S Medical Equip., Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K823727 · Richard'S Medical Equip., Inc. · Orthopedic device
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Mar 1983
Decision
88d
Days
Class 2
Risk

K823727 is an FDA 510(k) clearance for the SPECTRON PRIMARY STEM FEMORAL PROSTHES. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Richard'S Medical Equip., Inc. (Walker, US). The FDA issued a Cleared decision on March 8, 1983 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richard'S Medical Equip., Inc. devices

FDA 510(k) Submission Details - K823727

510(k) Number K823727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1982
Decision Date March 08, 1983
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K823727.
SPECTRON NECK REPLACEMENT PROSTHESIS
K823724 · Richard'S Medical Equip., Inc. · Mar 1983
TITANIUM M.E. MULLER TYPE TOTAL HIP
K830356 · Boehringer Mannheim Corp. · Mar 1983
SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
K823722 · Richard'S Medical Equip., Inc. · Mar 1983
SPECTRON PROTRUSIO CUP
K823725 · Richard'S Medical Equip., Inc. · Jan 1983
SPECTRON POLYETHYLENE ACCTUBULAR COMPON
K823728 · Richard'S Medical Equip., Inc. · Jan 1983
SPECTRON METAL BACK ACETABULAR COMPONENT
K823729 · Richard'S Medical Equip., Inc. · Jan 1983