Cleared Traditional

K925098 - BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE

K925098 is an FDA 510(k) clearance for BIOFIX ABSORBABLE SELF-REINFORCED POLY-..., manufactured by Bioscience, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 649-day FDA review.

K925098 · Bioscience, Inc. · Orthopedic device
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Jul 1994
Decision
649d
Days
Class 2
Risk

K925098 is an FDA 510(k) clearance for the BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Bioscience, Inc. (Washington, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 649 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Bioscience, Inc. devices

FDA 510(k) Submission Details - K925098

510(k) Number K925098 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 08, 1992
Decision Date July 19, 1994
Days to Decision 649 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
527d slower than avg
Panel avg: 122d · This submission: 649d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 160
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K925098.
SPETZLER PIN
K954001 · Howmedica Corp. · Oct 1995
FIXATION PINS/WIRES
K943856 · Acu Med, Inc. · Jul 1995
SPETZLER PIN
K945639 · Howmedica Corp. · Apr 1995
ACUFEX SMOOTH AND THREADED PINS
K931836 · Acufex Microsurgical, Inc. · Jun 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · Osteomed Corp. · Mar 1994
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993