Cleared Traditional

K930629 - ACRYL-X II SYSTEM

K930629 is an FDA 510(k) clearance for ACRYL-X II SYSTEM, manufactured by Sonokinetics, Inc.. The device is a Class 2 Orthopedic device with product code LZV cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K930629 · Sonokinetics, Inc. · Orthopedic device
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Jan 1994
Decision
347d
Days
Class 2
Risk

K930629 is an FDA 510(k) clearance for the ACRYL-X II SYSTEM. Classified as System, Cement Removal Extraction (product code LZV), Class II - Special Controls.

Submitted by Sonokinetics, Inc. (Hoboken, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4580 - 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. Elevated predicate reliance profile. 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 Sonokinetics, Inc. devices

FDA 510(k) Submission Details - K930629

510(k) Number K930629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date January 21, 1994
Days to Decision 347 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 122d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZV Device Classification - Class 2, Special Controls

Product Code LZV System, Cement Removal Extraction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4580
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.