(94 days)
No
The description focuses on mechanical fixation and structural integrity, with no mention of AI/ML capabilities or image processing.
Yes.
The device is used for internal fixation of fractures and reconstructions of bones, which is a therapeutic intervention.
No
Explanation: The device is an implantable plating system used for internal fixation of fractures and reconstructions of bones in the rearfoot. Its purpose is mechanical support and stabilization, not the diagnosis of a medical condition.
No
The device description explicitly states the components are made of pure titanium and includes plates and screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a set of surgical implants (plates and screws) and instruments used for internal fixation of bone fractures and reconstructions. These are physical devices implanted within the body during surgery.
- Intended Use: The intended use is for the surgical repair of bone fractures and reconstructions, not for testing biological samples.
The description clearly indicates a surgical implant system, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus. Examples of these internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.
Product codes
HRS, HWC
Device Description
The Flower Rearfoot Plating Set consists of the following components and accessories: calcaneal plates, MIS calcaneal plates, and calcaneal step osteotomy plates, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.
The Flower Rearfoot Plating Set consists of the following components/configurations:
- Calcaneal Plate, Small, with a width of 23.4 mm and a length of 51.9 mm; .
- Calcaneal Plate, Medium, with a width of 26.7 mm and a length of 57.9 mm; .
- Calcaneal Plate, Large, with a width of 30.0 mm and a length of 63.8 mm; .
- MIS Calcaneal Plate, Small, with a width of 23.4 mm and a length of 51.9 mm; t
- MIS Calcaneal Plate, Medium, with a width of 26.7 mm and a length of 57.9 mm; .
- MIS Calcaneal Plate, Large, with a width of 30.0 mm and a length of 63.8 mm; and .
- Osteotomy Step Plates with a width of 16 mm, lengths of 17, 19.5, and 21 mm, and offsets of t 5.0, 7.5, and 10.0 mm, respectively
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rearfoot, calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
An engineering analysis was performed to demonstrate that the components in the Flower Rearfoot Plating Set provide appropriate mechanical strength for the claimed intended use. Also, a Finite Element Analysis (FEA) was performed to compare physiological loading of the subject and predicate devices. The FEA results confirmed that the subject devices have, at minimum, equivalent strength.
Key Metrics
Not Found
Predicate Device(s)
K991407, K110670, K090675, K120667, K123562, K131657
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
MAR 2 7 2014
K133930
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510(k) SUMMARY
Flower Orthopedics Corporation's Rearfoot Plating Set
Submitter's Name. Address. Telephone Number, Contact Person and Date Prepared
Flower Orthopedics Corporation 100 Witmer Road, Suite 280 Horsham PA 19044
Phone: (215) 394-8903 (215) 394-8904 Facsimile:
Contact Person: Gary Barnett Date Prepared: December 19, 2013
Name of Device
Flower Rearfoot Plating Set
Common or Usual Name/Classification Name
The Flower Rearfoot Plating Set consists of bone plates classified under product code HRS (21 C.F.R. 888.3030, Single/multiple component metallic bone fixation appliance and accessories; Class II) and bone fixation screws classified under product code HWC (21 C.F.R. 888.3040, Smooth or threaded metallic bone fixation fastener; Class II).
Predicate Devices
Synthes USA, Locking Calcaneal Plates (K991407) Smith & Nephew, VLP Foot Plating System (K110670, K090675) Smith & Nephew, Peri-Loc Ankle Fusion Plating System (K120667) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657)
Intended Use / Indications for Use
The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstructions of bones of the rearfoot, including the calcaneus. Examples of these internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.
Device Description
The Flower Rearfoot Plating Set consists of the following components and accessories: calcaneal plates, MIS calcaneal plates, and calcaneal step osteotomy plates, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.
1
K133930
Technological Characteristics
The Flower Rearfoot Plating Set consists of the following components/configurations:
- Calcaneal Plate, Small, with a width of 23.4 mm and a length of 51.9 mm; .
- Calcaneal Plate, Medium, with a width of 26.7 mm and a length of 57.9 mm; .
- Calcaneal Plate, Large, with a width of 30.0 mm and a length of 63.8 mm; .
- MIS Calcaneal Plate, Small, with a width of 23.4 mm and a length of 51.9 mm; t
- MIS Calcaneal Plate, Medium, with a width of 26.7 mm and a length of 57.9 mm; .
- MIS Calcaneal Plate, Large, with a width of 30.0 mm and a length of 63.8 mm; and .
- Osteotomy Step Plates with a width of 16 mm, lengths of 17, 19.5, and 21 mm, and offsets of t 5.0, 7.5, and 10.0 mm, respectively
Substantial Equivalence
The Flower Rearfoot Plating Set is substantially equivalent to the identified predicate devices.
The subject devices have intended uses/indications, technological characteristics, and principles of operation as the predicate devices. An engineering analysis was performed to demonstrate that the components in the Flower Rearfoot Plating Set provide appropriate mechanical strength for the claimed intended use. Also, a Finite Element Analysis (FEA) was performed to compare physiological loading of the subject and predicate devices. The FEA results confirmed that the subject devices have, at minimum, equivalent strength. Thus, the subject rear foot plates are substantially equivalent.
2
TMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus, rendered in a bold, dark color.
Public Health Scrvice
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2014
Flower Orthopedics Corporation Mr. Gary Barnett RA/QA Manager 100 Witmer Road, Suite 280 Horsham, Pennsylvania 19044
Re: K133930
Trade/Device Name: Flower Rearfoot Plating Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 31, 2013 Received: January 03, 2014
Dear Mr. Barnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Gary Barnett
forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Flower Rearfoot Plating Set
Indications for Use:
The Flower Rearfoot Plating Set is intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. Examples of these internal fixations and reconstructions include, but are not limited to extra-articular fractures, intra-articular fractures, joint depression fractures, tongue type fractures, severely comminuted fractures and osteotomies.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet桐峪Frank -S
Division of Orthopedic Devices
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