Cleared Traditional

K920213 - MITEK ANCHOR, MITEK ANCHOR II

K920213 is an FDA 510(k) clearance for MITEK ANCHOR, manufactured by Mitek Surgical Products, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K920213 · Mitek Surgical Products, Inc. · Orthopedic device
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May 1992
Decision
106d
Days
Class 2
Risk

K920213 is an FDA 510(k) clearance for the MITEK ANCHOR, MITEK ANCHOR II. 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 May 1, 1992 after a review of 106 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

FDA 510(k) Submission Details - K920213

510(k) Number K920213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1992
Decision Date May 01, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

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 197
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K920213.
QUICKANCHOR
K924665 · Mitek Surgical Products, Inc. · Oct 1992
MITEK BONE ANCHOR, MODIFICATION
K915889 · Mitek Surgical Products, Inc. · Oct 1992
QUICKANCHOR, MODIFICATION
K921873 · Mitek Surgical Products, Inc. · Jun 1992
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
K911837 · Acufex Microsurgical, Inc. · Nov 1991
BIODEGRADABLE SURGICAL STAPLE
K910723 · Instrument Makar, Inc. · Mar 1991
SNAP-PAK (TM)
K905112 · Mitek Surgical Products, Inc. · Jan 1991