Cleared Traditional

K955003 - BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK

K955003 is an FDA 510(k) clearance for BIOFIX BIODEGRADABLE SELF-REINFORCED PO..., manufactured by Bioscience, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955003 · Bioscience, Inc. · Orthopedic device
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Jan 1996
Decision
91d
Days
Class 2
Risk

K955003 is an FDA 510(k) clearance for the BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Bioscience, Inc. (Washington, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Standard predicate reliance. 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 Bioscience, Inc. devices

FDA 510(k) Submission Details - K955003

510(k) Number K955003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date January 31, 1996
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 209
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K955003.
BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
K955768 · Bioscience, Inc. · Mar 1996
BIO-ANCHOR
K955486 · Linvatec Corp. · Feb 1996
PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
K952687 · Ethicon, Inc. · Feb 1996
ABSORBABLE BONE SCREW
K944544 · Johnson & Johnson Professionals, Inc. · Jan 1996
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K950275 · Zimmer, Inc. · Nov 1995
BIOABSORBABLE INTERFERENCE SCREW
K943249 · Instrument Makar, Inc. · Jul 1995