Cleared Special

K993975 - ABSOLUTE ABSORBABLE INTERFERENCE SCREW

K993975 is the FDA 510(k) clearance for ABSOLUTE ABSORBABLE INTERFERENCE SCREW by Innovasive Devices, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 26-day FDA review.

K993975 · Innovasive Devices, Inc. · Orthopedic device
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Dec 1999
Decision
26d
Days
Class 2
Risk

K993975 is an FDA 510(k) clearance for the ABSOLUTE ABSORBABLE 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 December 20, 1999 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Innovasive Devices, Inc. devices

Submission Details

510(k) Number K993975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1999
Decision Date December 20, 1999
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K993975.
THE LIGAMENT ANCHOR SOFT SCREW
K994152 · Corin USA · Mar 2000
ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM
K994202 · Smith & Nephew, Inc. · Feb 2000
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
K000089 · Synthes (Usa) · Feb 2000
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · Smith & Nephew, Inc. · Nov 1999
BONE BULLET SUTURE ANCHOR
K991024 · Linvatec Corp. · Nov 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · Biomet, Inc. · Oct 1999