Cleared Traditional

K930892 - MITEK MINI ANCHOR, MODIFICATION

K930892 is an FDA 510(k) clearance for MITEK MINI 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 339-day FDA review.

K930892 · Mitek Surgical Products, Inc. · Orthopedic device
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Jan 1994
Decision
339d
Days
Class 2
Risk

K930892 is an FDA 510(k) clearance for the MITEK MINI ANCHOR, MODIFICATION. 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 January 7, 1994 after a review of 339 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

FDA 510(k) Submission Details - K930892

510(k) Number K930892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1993
Decision Date January 07, 1994
Days to Decision 339 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
217d slower than avg
Panel avg: 122d · This submission: 339d
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 K930892.
MITEK GIII ANCHOR
K931782 · Mitek Surgical Products, Inc. · Jul 1994
QUICKANCHOR II
K931253 · Mitek Surgical Products, Inc. · Jun 1994
ACUFEX SURETAC
K931519 · Acufex Microsurgical, Inc. · Jun 1994
MITEK SUPER QUICKANCHOR, MODIFICATION
K930893 · Mitek Surgical Products, Inc. · Dec 1993
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993
MITEK LIGAMENT ANCHOR
K926270 · Mitek Surgical Products, Inc. · Oct 1993