Cleared Traditional

K972919 - BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW

K972919 is an FDA 510(k) clearance for BIOFIX BIOABSORBABLE SELF-REINFORCED PO..., manufactured by Bionx Implants, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K972919 · Bionx Implants, Inc. · Orthopedic device
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Mar 1998
Decision
232d
Days
Class 2
Risk

K972919 is an FDA 510(k) clearance for the BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Washington, US). The FDA issued a Cleared decision on March 27, 1998 after a review of 232 days - an extended review cycle.

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: 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 Bionx Implants, Inc. devices

FDA 510(k) Submission Details - K972919

510(k) Number K972919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1997
Decision Date March 27, 1998
Days to Decision 232 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
110d slower than avg
Panel avg: 122d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 741
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K972919.
HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS
K980364 · Howmedica Corp. · Apr 1998
INNOVASIVE DEVICES MENISCAL SCREW
K980681 · Innovasive Devices, Inc. · Apr 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440 · Depuy, Inc. · Apr 1998
AUTO-DRIVE BONE SCREW
K974785 · Osteomed Corp. · Mar 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · Biodynamic Technologies, Inc. · Mar 1998
MENISCAL REPAIR DEVICE
K974538 · Linvatec Corp. · Mar 1998