Cleared Traditional

K060746 - MEMORY STAPLE

K060746 is an FDA 510(k) clearance for MEMORY STAPLE, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K060746 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
66d
Days
Class 2
Risk

K060746 is an FDA 510(k) clearance for the MEMORY STAPLE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 25, 2006 after a review of 66 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 Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K060746

510(k) Number K060746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date May 25, 2006
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 130
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K060746.
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · Depuy Mitek, A Johnson & Johnson Company · Aug 2006
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006
LARGE UNI-CLIP STAPLE
K061594 · New Deal, S.A. · Jul 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
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052631 · Depuy Mitek, A Johnson & Johnson Company · Oct 2005
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
K051989 · Depuy Mitek, A Johnson & Johnson Company · Aug 2005