Cleared Traditional

K013629 - FINGER JOINT PROSTHESIS

K013629 is an FDA 510(k) clearance for FINGER JOINT PROSTHESIS, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KYJ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K013629 · Avanta Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
81d
Days
Class 2
Risk

K013629 is an FDA 510(k) clearance for the FINGER JOINT PROSTHESIS. Classified as Prosthesis, Finger, Constrained, Polymer (product code KYJ), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 25, 2002 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3230 - 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 Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K013629

510(k) Number K013629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date January 25, 2002
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYJ Device Classification - Class 2, Special Controls

Product Code KYJ Prosthesis, Finger, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3230
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 - KYJ Prosthesis, Finger, Constrained, Polymer

All 9
Devices cleared under the same product code (KYJ) and FDA review panel - the closest regulatory comparables to K013629.
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