Cleared Traditional

K897155 - MITEK ANCHOR(TM)

K897155 is the FDA 510(k) clearance for MITEK ANCHOR(TM) by Mitek Surgical Products, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K897155 · Mitek Surgical Products, Inc. · Orthopedic device
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Apr 1990
Decision
99d
Days
Class 2
Risk

K897155 is an FDA 510(k) clearance for the MITEK ANCHOR(TM). Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 K897155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date April 04, 1990
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 115
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K897155.
BARBED SQUARE STAPLE
K903273 · Onyx Medical Corp. · Jul 1990
MITEK ANCHOR II
K902751 · Mitek Surgical Products, Inc. · Jul 1990
HTO COMPRESSING STAPLE
K895117 · Howmedica Corp. · May 1990
MITEK ANCHOR
K892126 · Mitek Surgical Products, Inc. · Sep 1989
STAPLE FIXATION SYSTEM
K894929 · Concept, Inc. · Aug 1989
ORTHOMET ORTHOPEDIC STAPLES
K874914 · Orthomet, Inc. · Feb 1988