Cleared Traditional

SCHLEIN TRI-SURFACE ANKLE (K800530) - FDA 510(k) Clearance

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

K800530 · Orthopedic Equipment Co., Inc. · Orthopedic device
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Apr 1980
Decision
26d
Days
Class 2
Risk

K800530 is an FDA 510(k) clearance for the SCHLEIN TRI-SURFACE ANKLE. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Orthopedic Equipment Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - 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 Orthopedic Equipment Co., Inc. devices

Submission Details

510(k) Number K800530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1980
Decision Date April 02, 1980
Days to Decision 26 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
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 - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 56
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K800530.
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BRIGHAM TOTAL ANKLE PROSTHESIS
K803167 · Howmedica Corp. · Feb 1981
FORCEPS, ANKLE INSERTING, CON-AXIAL
K770420 · Depuy, Inc. · Mar 1977
COMPONENTS, ANKLE, TRIAL, CON-AXIAL
K770421 · Depuy, Inc. · Mar 1977