(29 days)
No
The device description and performance studies focus solely on the physical characteristics and mechanical performance of bone fixation hardware, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as "fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices," which are structural support and guidance functions, not therapeutic.
No
The device is described as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins, which are therapeutic and procedural functions, not diagnostic.
No
The device description clearly outlines physical hardware components (screws, pins, wires) made of specific materials and dimensions, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that these are implants (screws, pins, wires) intended for fixation within the bone for fractures, fusion, reconstruction, or as guide pins. This is a surgical device used inside the body (in vivo).
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, laboratory testing, or diagnostic purposes.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
Diamond Orthopedic Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices.
Product codes
HWC, JDW, HTY
Device Description
Diamond Orthopedic Bone Screws (cortical screws, cancellous screws, and headless compression screws) are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.
Diamond Orthopedic External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.
Diamond Orthopedic Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm, 0.7mm to 1.6mm, in lengths ranging from 101.6mm to 304.8mm and are partially or completely threaded, or smooth. Made of stainless steel or titanium.
Diamond Orthopedic Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.
Diamond Orthopedic Steinmann Pins are available in wire diameters ranging from 2mm to 4.7mm, in lengths ranging from 228.6mm to 304.8mm, are completely threaded, or smooth. Made of stainless steel or titanium.
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)
Non-Clinical Testing: The Bone Fixation Screws and Pins are identical in geometry and manufacturing to the predicate device. No new mechanical performance testing was performed. Sterilization validation, shelf life testing, LAL testing (bacterial endotoxin levels), and packaging testing were performed on the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medical Facet Bone Fixation Screws and Pins (K112727)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
Diamond Orthopedic, LLC % Lauren Smith Project Engineer JALEX Medical 30311 Clemens Road, Suite 5D Westlake, Ohio 44145
Re: K180932
Trade/Device Name: Diamond Orthopedic Bone Fixation Screws and Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. JDW. HTY Dated: April 9, 2018 Received: April 10, 2018
Dear Lauren Smith:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
May 9, 2018
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Diamond Orthopedic Bone Fixation Screws and Pins
Indications for Use (Describe)
Diamond Orthopedic Bone Fixation Screws and Pins are intended to be used as fixation implants for bone fractures, joint fusion, bone reconstruction, or as guide pins for insertion of other implantable devices.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Submitted by:
Date: Contact Person: Contact Telephone: Contact Fax: Device Trade Name: Device Classification Name:
Device Classification: Reviewing Panel: Product Code: Primary Predicate Device:
Device Description:
Diamond Orthopedic, LLC 1600 Camden Road Charlotte, North Carolina 28203
04/09/2018 Lauren Smith 440.541.0060 440.933.7839 Diamond Orthopedic Bone Fixation Screws and Pins Screw, Fixation, Bone Pin, Fixation Smooth or Threaded 21 CFR 888.3040 Orthopedic Panel HWC, JDW, HTY Medical Facet Bone Fixation Screws and Pins (K112727)
Diamond Orthopedic Bone Screws (cortical screws, cancellous screws, and headless compression screws) are available in thread diameters ranging from 1.5mm to 7.3mm, lengths ranging from 6mm to 180mm, and either solid or cannulated, and made of stainless steel or titanium.
Diamond Orthopedic External Fixation Screws are available in thread diameters ranging from 4mm to 6mm, lengths ranging from 60mm to 250mm, and thread lengths ranging from 18mm to 80mm, and made of stainless steel or titanium.
Diamond Orthopedic Kirschner Wires are available in wire diameters ranging from 1.0mm to 2.5mm, in lengths ranging from 100mm to 150mm, 0.7mm to 1.6mm, in lengths ranging from 101.6mm to 304.8mm and are partially or completely threaded, or smooth. Made of stainless steel or titanium.
Diamond Orthopedic Guide Wires are available in wire diameters ranging from 0.8mm to 2.8mm, in lengths ranging from 100mm to 450mm, are partially threaded or smooth. Made of stainless steel, titanium, or cobalt.
Diamond Orthopedic Steinmann Pins are available in wire diameters ranging from 2mm to 4.7mm, in lengths ranging from 228.6mm to 304.8mm, are completely threaded, or smooth. Made of stainless steel or titanium.
4
510(k) Summary
| Intended Use: | Diamond Orthopedic Bone Fixation Screws and Pins are
intended to be used as fixation implants for bone
fractures, joint fusion, bone reconstruction, or as guide
pins for insertion of other implantable devices. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Testing | The Bone Fixation Screws and Pins are identical in
geometry and manufacturing to the predicate device. No
new mechanical performance testing was performed.
Sterilization validation, shelf life testing, LAL testing
(bacterial endotoxin levels), and packaging testing were
performed on the subject device. |
| Substantial Equivalence: | The modified Bone Fixation Screws and Pins have the
same intended use, indications for use, principles of
operation, and technological characteristics of the
predicate. Modifications do not raise new questions of
safety or effectiveness. Therefore the modified Bone
Fixation Screws and Pins are substantially equivalent to
the predicate. |