Cleared Traditional

K073281 - CAIS STAPLE

K073281 is the FDA 510(k) clearance for CAIS STAPLE by Depuy Mitek, A Johnson & Johnson Company. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K073281 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
163d
Days
Class 2
Risk

K073281 is an FDA 510(k) clearance for the CAIS STAPLE. 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 May 2, 2008 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Depuy Mitek, A Johnson & Johnson Company devices

Submission Details

510(k) Number K073281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2007
Decision Date May 02, 2008
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K073281.
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · Biomet Manufacturing Corp · Nov 2014
MEMORY METAL STAPLES, EASYCLIP
K122113 · Stryker Corp. · Mar 2013
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008
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