Cleared Traditional

K132248 - FLOWER BONE SCREW SET

K132248 is an FDA 510(k) clearance for FLOWER BONE SCREW SET, manufactured by Flower Orthopedics Corporation. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K132248

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K132248.
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)
K131591 · Pega Medical, Inc. · Nov 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · Arthrex, Inc. · Nov 2013
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
K132893 · Icon Orthopaedic Concepts Dba Edge Orthopaedics · Nov 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
SELF-COMPRESSIVE SCREW
K131471 · Neosteo · Aug 2013
SWING-OFF SCREW
K130627 · Advanced Interventional Technology, LLC · Aug 2013