Cleared Traditional

K123562 - FLOWER SMALL AND MEDIUM BONE IMPLANTS

K123562 is the FDA 510(k) clearance for FLOWER SMALL AND MEDIUM BONE IMPLANTS by Flower Orthopedics Corporation. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K123562 · Flower Orthopedics Corporation · Orthopedic device
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Mar 2013
Decision
130d
Days
Class 2
Risk

K123562 is an FDA 510(k) clearance for the FLOWER SMALL AND MEDIUM BONE IMPLANTS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Flower Orthopedics Corporation (Philedelphia, US). The FDA issued a Cleared decision on March 29, 2013 after a review of 130 days - within the typical 510(k) review window.

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 Flower Orthopedics Corporation devices

Submission Details

510(k) Number K123562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date March 29, 2013
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 886
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K123562.
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