Cleared Traditional

K990454 - BIO-INTERFERENCE SCREW

K990454 is the FDA 510(k) clearance for BIO-INTERFERENCE SCREW by Innovasive Devices, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K990454 · Innovasive Devices, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 1999
Decision
139d
Days
Class 2
Risk

K990454 is an FDA 510(k) clearance for the BIO-INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Innovasive Devices, Inc. (Marlboro, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 139 days - within the typical 510(k) review window.

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 Innovasive Devices, Inc. devices

Submission Details

510(k) Number K990454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1999
Decision Date July 01, 1999
Days to Decision 139 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K990454.
BIOBUTTON
K990194 · Linvatec Corp. · Sep 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106 · Medartis AG · Sep 1999
BIORC ANCHOR
K990770 · Linvatec Corp. · Jul 1999
BONE MULCH SCREW SYSTEM
K991298 · Biomet, Inc. · May 1999
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM
K990776 · Aap Implantate AG · Apr 1999
STAYFUSE
K990804 · Pioneer Surgical Technology · Apr 1999