Cleared Traditional

K920802 - ALVINE TOTAL ANKLE

K920802 is an FDA 510(k) clearance for ALVINE TOTAL ANKLE, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K920802 · Depuy, Inc. · Orthopedic device
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Dec 1992
Decision
300d
Days
Class 2
Risk

K920802 is an FDA 510(k) clearance for the ALVINE TOTAL ANKLE. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K920802

510(k) Number K920802 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 21, 1992
Decision Date December 17, 1992
Days to Decision 300 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
178d slower than avg
Panel avg: 122d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSN Device Classification - Class 2, Special Controls

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 65
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K920802.
AGILITY LP TOTAL ANKLE PROSTHESIS
K053569 · DePuy Orthopaedics, Inc. · Mar 2006
TOPEZ TOTAL ANKLE REPLACEMENT
K051023 · Topez Orthopedics, Inc. · Nov 2005
AGILITY ANKLE REVISION PROSTHESIS
K020541 · Depuy, Inc. · May 2002
BRIGHAM TOTAL ANKLE PROSTHESIS
K803167 · Howmedica Corp. · Feb 1981
SCHLEIN TRI-SURFACE ANKLE
K800530 · Orthopedic Equipment Co., Inc. · Apr 1980
FORCEPS, ANKLE INSERTING, CON-AXIAL
K770420 · Depuy, Inc. · Mar 1977