(103 days)
Not Found
No
The summary describes a set of bone screws and instruments made of titanium alloy, with performance studies focused on mechanical strength and biocompatibility. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies.
Yes
The device is described as being used for "fixation of bone fractures, fusion of joints or bone reconstruction," which directly addresses a medical condition or injury.
No
The device is a bone screw set used for fixation of bone fractures, fusion of joints, or bone reconstruction, which are treatment or structural support functions rather than diagnostic ones.
No
The device description explicitly lists physical components made of titanium alloy (screws, washers) and general purpose instruments, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of bone fractures, fusion of joints or bone reconstruction." This is a direct surgical intervention on the human body.
- Device Description: The description details physical components like screws and washers made of titanium alloy, used for mechanical support within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not perform any such analysis.
The information provided describes a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flower Bone Screw set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC; HTN
Device Description
The Flower Bone Screw Set consists of the following components and accessories: solid, cannulated, and headless compression screws, as well as washers, all made of a titanium alloy compliant with ASTM F136. The device is provided with general purpose instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Flower Bone Screw Set was tested (worse case) according to the following standards:
- . ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401);
- ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel (ISO . 7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000;
- . ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- . ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. (Sterility)
In addition, an engineering analysis has been performed to demonstrate that the Flower Orthopedics cannulated, solid and headless compression bone screws provide appropriate mechanical strength for the claimed intended use.
In all instances, the Flower Bone Screw Set functioned as intended and test results, as well as an engineering analysis, demonstrate substantial equivalence with the cited predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medical Facets Bone Fixation Screws and Pins (K112727), Howmedica Asnis Micro Cannulated Screw (K071092), Treu Bone Fixation Screws and Pins (K083912), Synthes 4.5mm and 6.5mm Headless Compression Screws (K080943), Flower Small and Medium Implant Set (K123562)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K132248
510(k) SUMMARY
Flower Bone Screw Set
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Flower Orthopedics Corporation 7715 Crittenden Street, #413 Philadelphia, PA 19118
(267) 437 3063 Phone: (267) 437 3072 Facsimile:
OCT 30 2013
Contact Person: Oliver Burckhardt, Chief Executive Officer Date Prepared: October 29, 2013
Name of Device and Name/Address of Sponsor
Flower Bone Screw Set
Common or Usual Name/Classification Name
Bone Fixation Screw
Product Codes: HWC; HTN (Orthopedic Review Panel)
Product Classifications: 21 C.F.R. 888.3040 - Smooth or Threaded Metallic Bone Fixation Fastner: 21 C.F.R. 888.3030 - Single/multiple component metallic bone fixation appliances and accessories
Predicate Devices
Medical Facets Bone Fixation Screws and Pins (K112727) Howmedica Asnis Micro Cannulated Screw (K071092) Treu Bone Fixation Screws and Pins (K083912) Synthes 4.5mm and 6.5mm Headless Compression Screws (K080943) Flower Small and Medium Implant Set (K123562)
Intended Use / Indications for Use
The Flower Bone Screw set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.
Device Description
The Flower Bone Screw Set consists of the following components and accessories: solid, cannulated, and headless compression screws, as well as washers, all made of a titanium alloy compliant with ASTM F136. The device is provided with general purpose instruments.
Technological Characteristics
The Flower Bone Screw Set consists of the following components/configurations:
1
- Cannulated Bone Screws with a diameter range of 2.0-7.3mm and a length range of . 10.0-130.0mm;
- Solid Bone Screws with a diameter range of 2.0-4.5mm and a length range of 10.0-● 70.0mm: and
- . Headless Compression Bone Screws with a 6.5mm diameter and a length range of 45.0-130.0mm.
Performance Data
The Flower Bone Screw Set was tested (worse case) according to the following standards:
- . ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401);
- ISO 7153-1, Surgical instruments Metallic materials Part 1: Stainless steel (ISO . 7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000;
- . ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- . ISO 11137-1, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. (Sterility)
In addition, an engineering analysis has been performed to demonstrate that the Flower Orthopedics cannulated, solid and headless compression bone screws provide appropriate mechanical strength for the claimed intended use.
In all instances, the Flower Bone Screw Set functioned as intended and test results, as well as an engineering analysis, demonstrate substantial equivalence with the cited predicate devices.
Substantial Equivalence
The Flower Bone Screw Set is substantially equivalent to the identified predicate devices. The subject devices have intended uses lindications, technological characteristics, and principles of operation as its predicate devices. An engineering analysis was performed to demonstrate that the Flower Orthopedics cannulated, solid and headless compression bone screws provide appropriate mechanical strength for the claimed intended use. Thus. the subject bone screws are substantially equivalent.
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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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2013
Flower Orthopedics Corporation % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K132248
Trade/Device Name: Flower Bone Screw Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: September 18, 2013 Received: September 18, 2013
Dear Ms. Hogan:
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 - Ms. Janice M. Hogan
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" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erin] - Joseith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): __ K132248
Device Name:
Indications for Use:
The Flower Bone Screw Set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.
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)
and the comments of the comments of the comments of the comments of the comments of the comments of
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth Frank -S
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Division of Orthopedic Devices