Cleared Special

K990160 - MICROTAC-BONE ANCHOR SYSTEM

K990160 is the FDA 510(k) clearance for MICROTAC-BONE ANCHOR SYSTEM by Influence, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Special 510(k) pathway after a 28-day FDA review.

K990160 · Influence, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
28d
Days
Class 2
Risk

K990160 is an FDA 510(k) clearance for the MICROTAC-BONE ANCHOR SYSTEM. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Influence, Inc. (Washington, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 28 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 Influence, Inc. devices

Submission Details

510(k) Number K990160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1999
Decision Date February 16, 1999
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K990160.
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · American Medical Systems, Inc. · Mar 2000
ACUMED SUTURE ANCHOR
K993657 · Acu Med, Inc. · Jan 2000
BONE ANCHOR SYSTEM III (BAS III)
K990295 · Boston Scientific Corp · Mar 1999
IMPLEX SCREW AND WASHER SYSTEM
K982751 · Implex Corp. · Feb 1999
STRYKER WEDGE SUTURE ANCHOR
K983557 · Stryker Endoscopy · Dec 1998
KSEA FLIPPTACK
K982571 · KARL STORZ Endoscopy-America, Inc. · Sep 1998