Cleared Traditional

K982420 - MITEK MICRO ANCHOR

K982420 is an FDA 510(k) clearance for MITEK MICRO ANCHOR, manufactured by Mitek Products. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K982420 · Mitek Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
70d
Days
Class 2
Risk

K982420 is an FDA 510(k) clearance for the MITEK MICRO ANCHOR. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Mitek Products (Westwood, US). The FDA issued a Cleared decision on August 24, 1998 after a review of 70 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mitek Products devices

FDA 510(k) Submission Details - K982420

510(k) Number K982420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date August 24, 1998
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 198
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K982420.
SOLUSTAPLE
K991566 · New Deal, S.A. · Aug 1999
UNI-CLIP STAPLE
K991482 · New Deal, S.A. · Jun 1999
POLYMER OBL SB ANCHOR / SUTURE COMBINATION
K982996 · Orthopaedic Biosystems, Ltd. · Mar 1999
LACTOSORB POP RIVET
K981798 · Biomet, Inc. · Jul 1998
MEMORY STAPLE (20 SIZES AVAILABLE)
K964226 · Landos, Inc. · Aug 1997
HOWMEDICA MAINSTAY ANCHOR
K965175 · Howmedica Corp. · Mar 1997