Cleared Special

K062170 - BIOKNOTLESS AND LUPINE PLUS ANCHORS

K062170 is the FDA 510(k) clearance for BIOKNOTLESS AND LUPINE PLUS ANCHORS by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code JDR) cleared through the Special 510(k) pathway after a 22-day FDA review.

K062170 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
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Aug 2006
Decision
22d
Days
Class 2
Risk

K062170 is an FDA 510(k) clearance for the BIOKNOTLESS AND LUPINE PLUS ANCHORS. 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 August 22, 2006 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Depuy Mitek, A Johnson & Johnson Company devices

Submission Details

510(k) Number K062170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date August 22, 2006
Days to Decision 22 days
Submission Type Special
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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 97
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K062170.
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008
BIOPRO MEMORY STAPLE, MODELS 18062-18073
K072298 · Biopro, Inc. · Oct 2007
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
K071257 · Depuy Mitek, A Johnson & Johnson Company · Jun 2007
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006
MEMORY STAPLE
K060746 · DePuy Orthopaedics, Inc. · May 2006
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE
K060553 · Depuy Mitek, A Johnson & Johnson Company · May 2006