Cleared Traditional

K071257 - MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD

K071257 is an FDA 510(k) clearance for MINI QUICKANCHOR AND QUICKANCHOR PLUS W..., manufactured by Depuy Mitek, A Johnson & Johnson Company. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K071257 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
56d
Days
Class 2
Risk

K071257 is an FDA 510(k) clearance for the MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 56 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 Depuy Mitek, A Johnson & Johnson Company devices

FDA 510(k) Submission Details - K071257

510(k) Number K071257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2007
Decision Date June 29, 2007
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 190
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K071257.
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008
BIOPRO MEMORY STAPLE, MODELS 18062-18073
K072298 · Biopro, Inc. · Oct 2007
SBI STAFIX
K071479 · Small Bone Innovations, Inc. · Aug 2007
NEXFIX COMPRESSION STAPLE
K070688 · Nexa Orthopedics, Inc. · May 2007
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
K061776 · Arthrotek, Inc. · Sep 2006
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · Depuy Mitek, A Johnson & Johnson Company · Aug 2006