Cleared Traditional

K823724 - SPECTRON NECK REPLACEMENT PROSTHESIS

K823724 is an FDA 510(k) clearance for SPECTRON NECK REPLACEMENT PROSTHESIS, 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 89-day FDA review.

K823724 · Richard'S Medical Equip., Inc. · Orthopedic device
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Mar 1983
Decision
89d
Days
Class 2
Risk

K823724 is an FDA 510(k) clearance for the SPECTRON NECK REPLACEMENT PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Richard'S Medical Equip., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 89 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 - K823724

510(k) Number K823724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1982
Decision Date March 09, 1983
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 K823724.
CEMENTED 101 32 FEMORAL COMPONENT
K830750 · Intermedics Orthopedics · May 1983
POROCOAT DUAL-LOCK TOTAL HIP SYSTEM
K830004 · Depuy, Inc. · Apr 1983
SPECTRON PROXIMAL FEMORAL PROSTHESIS
K823723 · 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 PRIMARY STEM FEMORAL PROSTHES
K823727 · Richard'S Medical Equip., Inc. · Mar 1983