Cleared Traditional

K930125 - PHOENIX BONE SCREWS PBS-TYPE SERIES

K930125 is an FDA 510(k) clearance for PHOENIX BONE SCREWS PBS-TYPE SERIES, manufactured by Phoenix Bioengineering, Inc.. The device is a Class 2 Orthopedic device with product code HXA cleared through the Traditional 510(k) pathway after a 352-day FDA review.

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

FDA 510(k) Submission Details - K930125

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.

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

All 9
Devices cleared under the same product code (HXA) and FDA review panel - the closest regulatory comparables to K930125.
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H-H HUNTER ACTIVE TENDON IMPLANT DC
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H-H HUNTER ACTIVE TENDON IMPLANT BC
K872293 · Holter-Hausner Intl. · Sep 1987