Cleared Traditional

K953877 - MITEK GII ANCHOR

K953877 is the FDA 510(k) clearance for MITEK GII ANCHOR by Mitek Surgical Products, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K953877 · Mitek Surgical Products, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 1995
Decision
165d
Days
Class 2
Risk

K953877 is an FDA 510(k) clearance for the MITEK GII ANCHOR. 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 Mitek Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on December 29, 1995 after a review of 165 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 Mitek Surgical Products, Inc. devices

Submission Details

510(k) Number K953877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date December 29, 1995
Days to Decision 165 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
43d slower than avg
Panel avg: 122d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K953877.
QUESTLOCK ACL FIXATOR
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WASHER
K953702 · Linvatec Corp. · Oct 1995
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K953264 · Wrightmedicaltechnologyinc · Oct 1995
ARTHREX SUTURE ANCHOR SCREW SYSTEM
K934327 · Arthrex, Inc. · Sep 1995