Cleared Traditional

K930125 - PHOENIX BONE SCREWS PBS-TYPE SERIES (FDA 510(k) Clearance)

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

K930125 · Phoenix Bioengineering, Inc. · Orthopedic device
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Dec 1993
Decision
352d
Days
Class 2
Risk

K930125 is an FDA 510(k) clearance for the PHOENIX BONE SCREWS PBS-TYPE SERIES. Classified as Prosthesis, Tendon, Passive (product code HXA), Class II - Special Controls.

Submitted by Phoenix Bioengineering, Inc. (Bridgeport, US). The FDA issued a Cleared decision on December 30, 1993 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 Phoenix Bioengineering, Inc. devices

Submission Details

510(k) Number K930125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date December 30, 1993
Days to Decision 352 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 122d · This submission: 352d
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.