Cleared Traditional

K132248 - FLOWER BONE SCREW SET

K132248 is the FDA 510(k) clearance for FLOWER BONE SCREW SET by Flower Orthopedics Corporation. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K132248 · Flower Orthopedics Corporation · Orthopedic device
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Oct 2013
Decision
103d
Days
Class 2
Risk

K132248 is an FDA 510(k) clearance for the FLOWER BONE SCREW SET. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Flower Orthopedics Corporation (Philedelphia, US). The FDA issued a Cleared decision on October 30, 2013 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K132248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2013
Decision Date October 30, 2013
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 553
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K132248.
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