Cleared Traditional

K872285 - H-H HUNTER ACTIVE TENDON IMPLANT DC

K872285 is an FDA 510(k) clearance for H-H HUNTER ACTIVE TENDON IMPLANT DC, manufactured by Holter-Hausner Intl.. The device is a Class 2 Orthopedic device with product code HXA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K872285 · Holter-Hausner Intl. · Orthopedic device
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Sep 1987
Decision
104d
Days
Class 2
Risk

K872285 is an FDA 510(k) clearance for the H-H HUNTER ACTIVE TENDON IMPLANT DC. 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

FDA 510(k) Submission Details - K872285

510(k) Number K872285 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
Combination Product No
PCCP Authorized No
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.

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

Devices cleared under the same product code (HXA) and FDA review panel - the closest regulatory comparables to K872285.
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 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
PASSIVE TENDON IMPLANT
K780320 · Holter-Hausner Intl. · Mar 1978