Cleared Traditional

K062734 - ADJUST-RIGHT FIXATION DEVICES

K062734 is an FDA 510(k) clearance for ADJUST-RIGHT FIXATION DEVICES, manufactured by Valpo Orthopedic Technology, Inc.. 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.

K062734 · Valpo Orthopedic Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
70d
Days
Class 2
Risk

K062734 is an FDA 510(k) clearance for the ADJUST-RIGHT FIXATION DEVICES. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Valpo Orthopedic Technology, Inc. (Valparaiso, US). The FDA issued a Cleared decision on November 22, 2006 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.

FDA 510(k) Submission Details - K062734

510(k) Number K062734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2006
Decision Date November 22, 2006
Days to Decision 70 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 232
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K062734.
NEXFIX COMPRESSION STAPLE
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K063273 · Depuy Miltek, A Johnson & Johnson Co. · Nov 2006
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
K061776 · Arthrotek, Inc. · Sep 2006
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · Depuy Mitek, A Johnson & Johnson Company · Aug 2006
K062734 · ADJUST-RIGHT FIXATION DEVICES
Download PDF FDA Summary Valpo Orthopedic Tech…