Cleared Traditional

K872284 - H-H HUNTER ACTIVE TENDON IMPLANT PC (FDA 510(k) Clearance)

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

K872284 · Holter-Hausner Intl. · Orthopedic device
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Sep 1987
Decision
104d
Days
Class 2
Risk

K872284 is an FDA 510(k) clearance for the H-H HUNTER ACTIVE TENDON IMPLANT PC. Classified as Prosthesis, Tendon, Passive (product code HXA), Class II - Special Controls.

Submitted by Holter-Hausner Intl. (Bridgeport, US). The FDA issued a Cleared decision on September 28, 1987 after a review of 104 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 Holter-Hausner Intl. devices

Submission Details

510(k) Number K872284 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 16, 1987
Decision Date September 28, 1987
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.