Cleared Traditional

K964359 - AVANTA ORTHOPAEDICS TENDON SPACER

K964359 is an FDA 510(k) clearance for AVANTA ORTHOPAEDICS TENDON SPACER, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HXA cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K964359 · Avanta Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
144d
Days
Class 2
Risk

K964359 is an FDA 510(k) clearance for the AVANTA ORTHOPAEDICS TENDON SPACER. Classified as Prosthesis, Tendon, Passive (product code HXA), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 25, 1997 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3025 - 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 Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K964359

510(k) Number K964359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date March 25, 1997
Days to Decision 144 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
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HXA Device Classification - Class 2, Special Controls

Product Code HXA Prosthesis, Tendon, Passive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3025
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 - HXA Prosthesis, Tendon, Passive

All 7
Devices cleared under the same product code (HXA) and FDA review panel - the closest regulatory comparables to K964359.
Universal Tendon Spacer
K243477 · Askorn Medical · Jan 2025
H-H HUNTER ACTIVE TENDON IMPLANT PC
K872284 · Holter-Hausner Intl. · Sep 1987
H-H HUNTER ACTIVE TENDON IMPLANT DC
K872285 · Holter-Hausner Intl. · Sep 1987
H-H HUNTER ACTIVE TENDON IMPLANT BC
K872293 · Holter-Hausner Intl. · Sep 1987
H-H HUNTER ACTIVE TENDON IMPLANT
K853438 · Holter-Hausner Intl. · Sep 1985
TENDON ROD MODEL OR41PO3-6
K781943 · Holter-Hausner Intl. · Dec 1978