Cleared Traditional

K926270 - MITEK LIGAMENT ANCHOR

K926270 is the FDA 510(k) clearance for MITEK LIGAMENT ANCHOR by Mitek Surgical Products, Inc.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K926270 · Mitek Surgical Products, Inc. · Orthopedic device
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Oct 1993
Decision
308d
Days
Class 2
Risk

K926270 is an FDA 510(k) clearance for the MITEK LIGAMENT ANCHOR. 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 October 22, 1993 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K926270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1992
Decision Date October 22, 1993
Days to Decision 308 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
186d slower than avg
Panel avg: 122d · This submission: 308d
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 K926270.
MITEK MINI ANCHOR, MODIFICATION
K930892 · Mitek Surgical Products, Inc. · Jan 1994
MITEK SUPER QUICKANCHOR, MODIFICATION
K930893 · Mitek Surgical Products, Inc. · Dec 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993
ACUFEX SURETAC(R) PAC
K930538 · Acufex Microsurgical, Inc. · Sep 1993
MINVASIVE SUTURE BONE FASTENER
K924034 · Innovasive Devices, Inc. · Aug 1993
ACUFEX(R) TAG(TM)
K911293 · Acufex Microsurgical, Inc. · Jul 1993