(91 days)
Not Found
No
The description focuses on the mechanical properties and intended use of bone screws, with no mention of AI or ML.
Yes:
The device is used for the fixation of bone fractures, fusion of joints, or bone reconstruction, which are therapeutic interventions.
No
The device description states its intended use is for "fixation of bone fractures, fusion of joints or bone reconstruction," which are treatment procedures, not diagnostic ones. There is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly states it is a "Flower Bone Screw Set" consisting of "headless compression screws and cannulated bone screws, made of a titanium alloy." This indicates a physical hardware device, not software.
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. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the Flower Bone Screw Set is used for the fixation of bone fractures, fusion of joints or bone reconstruction. This is a surgical implant used within the body to physically support and stabilize bone.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose.
Therefore, based on the provided information, the Flower Bone Screw Set is 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 joints or bone reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The subject Flower Bone Screw Set is an extension of the Flower Bone Screw Set (K132248) consisting of headless compression screws and cannulated bone screws, made of a titanium alloy compliant with ISO 5832-3. 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 (worst case) according to or conforms to the following standards:
- ASTM/AAMI ST72, Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing
In addition, an engineering analysis has been performed to demonstrate that the Flower Orthopedics bone screws provide adequate and substantially equivalent mechanical strength for the claimed intended use.
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.
Flower Bone Screw Set (K132248), Flower Small and Medium Implant Set (K123562), Medical Facet's Bone Fixation Screws and Pins (K112727)
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
June 6, 2017
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Flower Orthopedics Corporation Ms. Jessica Huang Manager, Regulatory Affairs and Quality Assurance 100 Witmer Road. Suite 280 Horsham, Pennsylvania 19044
Re: K170687
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 Dated: May 5, 2017 Received: May 8, 2017
Dear Ms. Jessica Huang:
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 of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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, Vincent J. Devlin -S 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
510(k) Number (if known)
Device Name
Flower Bone Screw Set
Indications for Use (Describe)
The Flower Bone Screw Set is intended to be used for the fixation of joints or bone reconstruction.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) SUMMARY
Flower Bone Screw 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) 323-4018 (215) 394-8904 Facsimile:
Contact Person: Jessica Huang, Manager, Quality Assurance and Regulatory Affairs Date Prepared: June 6, 2017
Name of Device and Name/Address of Sponsor
Flower Bone Screw Set Flower Orthopedics Corporation 100 Witmer Rd. Suite 280 Horsham, PA 19044
Common or Usual Name/Classification Name
Bone Fixation Screw (Product Code: HWC); Product classification: 21 C.F.R. 888.3040 – Smooth or threaded metallic bone fixation fastener
Predicate Devices
Flower Bone Screw Set (K132248) Flower Small and Medium Implant Set (K123562) Medical Facet's Bone Fixation Screws and Pins (K112727)
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 subject Flower Bone Screw Set is an extension of the Flower Bone Screw Set (K132248) consisting of headless compression screws and cannulated bone screws, made of a titanium alloy compliant with ISO 5832-3. The device is provided with general purpose instruments.
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Changes from Predicate
The purpose of this submission is to add components to the Flower Bone Screw Set cleared in K132248. The standard construct is modified by adding sizes for Headless Compression Screw and Cannulated Screws not included in the previous submission.
Technological Characteristics
The following components/configurations are being added to the Flower Bone Screw Set:
- Cannulated Bone Screws with a diameters of 2.0mm and 2.4mm with additional ● lengths of 6mm and 8mm with total lengths ranging from 6mm to 50mm;
- Cannulated Screws of 3.0mm diameter with minor change to thread lengths; ●
- Headless Compression Bone Screws with 2.2mm, 3.0mm, 3.5mm, 4.0mm ● diameters and a length range of 6.0-60.0mm.
Performance Data
The Flower Bone Screw Set was tested (worst case) according to or conforms to the following standards:
- ASTM/AAMI ST72, Bacterial endotoxins Test methods, routine monitoring, and ● alternatives to batch testing
In addition, an engineering analysis has been performed to demonstrate that the Flower Orthopedics bone screws provide adequate and substantially equivalent mechanical strength for the claimed intended use.
Conclusion
The Flower Bone Screw set is very similar to the previously cleared Flower Bone Screw Set. The subject devices have the same intended uses and indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the subject devices and the predicate devices raise no new issues of safety or effectiveness. An engineering analysis was performed to demonstrate that the Flower Orthopedics bone screw set provides appropriate mechanical strength for the claimed intended use. Thus, the subject bone screw set is substantially equivalent to the predicate devices.