Cleared Traditional

K853438 - H-H HUNTER ACTIVE TENDON IMPLANT

K853438 is an FDA 510(k) clearance for H-H HUNTER ACTIVE TENDON IMPLANT, 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 46-day FDA review.

K853438 · Holter-Hausner Intl. · Orthopedic device
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Sep 1985
Decision
46d
Days
Class 2
Risk

K853438 is an FDA 510(k) clearance for the H-H HUNTER ACTIVE TENDON IMPLANT. 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 30, 1985 after a review of 46 days - a notably fast clearance cycle.

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: 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 Holter-Hausner Intl. devices

FDA 510(k) Submission Details - K853438

510(k) Number K853438 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 15, 1985
Decision Date September 30, 1985
Days to Decision 46 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
76d faster than avg
Panel avg: 122d · This submission: 46d
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 K853438.
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
TENDON ROD MODEL OR41PO3-6
K781943 · Holter-Hausner Intl. · Dec 1978
PASSIVE TENDON IMPLANT
K780320 · Holter-Hausner Intl. · Mar 1978