Cleared Special

K131657 - FLOWER SMALL AND MEDIUM IMPLANT SET

K131657 is an FDA 510(k) clearance for FLOWER SMALL AND MEDIUM IMPLANT SET, manufactured by Flower Orthopedics Corporation. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 77-day FDA review.

K131657 · Flower Orthopedics Corporation · Orthopedic device
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Aug 2013
Decision
77d
Days
Class 2
Risk

K131657 is an FDA 510(k) clearance for the FLOWER SMALL AND MEDIUM IMPLANT SET. 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 August 22, 2013 after a review of 77 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Flower Orthopedics Corporation devices

FDA 510(k) Submission Details - K131657

510(k) Number K131657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2013
Decision Date August 22, 2013
Days to Decision 77 days
Submission Type Special
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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

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 1216
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K131657.
MAXLOCK EXTREME SYSTEM
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ARIX FOOT SYSTEM
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ACUMED WRIST SPANNING PLATE
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METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
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METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
K131759 · Tianjin Walkman Biomaterial Co., Ltd. · Aug 2013
INTEGRA TITANIUM BONE WEDGE
K131360 · Ascension Orthopedic · Aug 2013