Cleared Traditional

K801952 - SPINE ALIGN

K801952 is an FDA 510(k) clearance for SPINE ALIGN, manufactured by B.H. Richardson, D.C.. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K801952 · B.H. Richardson, D.C. · Orthopedic device
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Sep 1980
Decision
29d
Days
Class 2
Risk

K801952 is an FDA 510(k) clearance for the SPINE ALIGN. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by B.H. Richardson, D.C. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3770 - 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.

FDA 510(k) Submission Details - K801952

510(k) Number K801952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1980
Decision Date September 16, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYI Device Classification - Class 2, Special Controls

Product Code KYI Prosthesis, Wrist, Carpal Trapezium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3770
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 - KYI Prosthesis, Wrist, Carpal Trapezium

All 24
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K801952.
STRICKLAND TRAPEZIAL IMPLANT
K951471 · Wrightmedicaltechnologyinc · Aug 1995
SWANSON TITANIUM CONDYLAR IMPLANT
K864488 · Dow Corning Wright · Apr 1987
SWANSON TITANIUM TRAPEZIUM IMPLANT
K864489 · Dow Corning Wright · Apr 1987
SILASTIC H.P. TRAPEXIAL IMPLANT
K781756 · Dow Corning Corp. Healthcare Industries Materials · Nov 1978
K801952 · SPINE ALIGN
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