Cleared Traditional

K961094 - MITEK THREADED ANCHOR (MODIFICATION)

K961094 is the FDA 510(k) clearance for MITEK THREADED ANCHOR (MODIFICATION) by Mitek Products. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K961094 · Mitek Products · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
203d
Days
Class 2
Risk

K961094 is an FDA 510(k) clearance for the MITEK THREADED ANCHOR (MODIFICATION). 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 Products (Westwood, US). The FDA issued a Cleared decision on October 3, 1996 after a review of 203 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 Products devices

Submission Details

510(k) Number K961094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1996
Decision Date October 03, 1996
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 423
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K961094.
ANSPACH SUTURE ANCHOR (MODIFIED)
K963686 · The Anspach Effort, Inc. · Nov 1996
MITEK MICRO ANCHOR
K962511 · Mitek Products · Nov 1996
INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
K963402 · Innovasive Devices, Inc. · Nov 1996
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K963200 · Wrightmedicaltechnologyinc · Oct 1996
ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963217 · Wrightmedicaltechnologyinc · Oct 1996
STATAK SOFT TISSUE ATTACHMENT DEVICE
K962397 · Zimmer, Inc. · Aug 1996