(43 days)
No
The description focuses on the mechanical properties, materials, and design of the plating system for fracture fixation, with no mention of AI or ML technologies.
Yes
Explanation: The device is indicated for fixation of fractures and non-unions of the ulna, which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is an Ulna Plating System, which is used for the fixation of fractures and non-unions of the ulna. This is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description explicitly details physical components made of titanium and cobalt chromium alloys (plates, screws, instruments) intended for surgical implantation and fixation. It also describes mechanical performance testing (construct testing, 4-point bend testing, galvanic corrosion evaluation), which are characteristic of hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of fractures and non-unions of the ulna". This is a surgical procedure performed directly on the patient's bone.
- Device Description: The device is a "Ulna Plating System" comprised of plates, screws, and instruments. These are physical implants and tools used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The System is indicated for fixation of fractures and non-unions of the ulna, particularly in osteopenic bone.
Product codes
HRS
Device Description
The Ulna Plating System is comprised of two new low profile plates anatomically contoured for the ulna, existing screws and both system specific and general instrumentation. The plates, locking screws and non-locking screws are manufactured from titanium alloy Ti6Al4V ELI per ASTM F136. All the plates are Type II anodized. The plates incorporate both locking and nonlocking holes that allow the surgeon to stabilize the fracture by the use of compression plating techniques and then obtain neutralization of the construct with the locking screws. The locking screws construct can protect the compression screws while providing relative stability across extensive comminution of in osteopenic bone. The plate material and the inclusion of both locking and non-locking holes are design features also included in the predicate device cleared in K083843. The plates are designed to accept existing 2.7mm locking screws, 2.7mm non-locking screws, and 2.7mm multidirectional screws. The non-locking and locking screws are manufactured from Titanium Alloy per ASTM F-136 and are color anodized. The multidirectional screws are manufactured from Cobalt Chromium Alloy per ASTM 1537. The predicate also includes Cobalt Chromium (ASTM F1537) multidirectional screws. The Ulna Plating System will offer the surgeon several system specific instruments as well as various general instruments to facilitate the installation of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna
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 performance testing included construct testing as well as 4-point bend testing per ASTM F382 to determine substantial equivalence of the Ulna Plating System. A Galvanic Corrosion engineering evaluation was also completed and was found to meet the acceptance criteria. Results indicate that the subject plating system is substantially equivalent to legally marketed devices.
No clinical tests are provided for basis of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 12, 2016
Biomet Inc. Ms. Julie Largent Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K162424
Trade/Device Name: Ulna Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 29, 2016 Received: August 30, 2016
Dear Ms. Largent:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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 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,
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Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) TBD
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Device Name Ulna Plating System
Indications for Use (Describe)
The System is indicated for fixation of fractures and non-unions of the ulna, particularly in osteopenic bone.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Image /page/3/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside of it, followed by the text "ZIMMER BIOMET" in gray. The logo is simple and modern, and it is likely used to represent the company's brand.
Ulna Plating System | Traditional 510(k)
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Ulna Plating System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc. |
|---|---|
| 56 East Bell Drive | |
| PO Box 587 | |
| Warsaw, IN 46581 | |
| Establishment Registration Number: 1825034 | |
| Contact: | Julie Largent |
| Regulatory Affairs Specialist | |
| 305-269-6391 | |
| Date: | October 5, 2016 |
| Subject Device: | Trade Name: Ulna Plating System |
| Common Name: Plate, Fixation, Bone | |
| Classification Name: | |
| HRS- Single/multiple component metallic bone fixation appliance | |
| and accessories (21 CFR 888.3030) |
Legally marketed devices to which substantial equivalence is claimed:
- Locking Anatomic and Composite Plate System K0838432
- Distal Volar Radius Plating System K112345
Device Description
The Ulna Plating System is comprised of two new low profile plates anatomically contoured for the ulna, existing screws and both system specific and general instrumentation. The plates, locking screws and non-locking screws are manufactured from titanium alloy Ti6Al4V ELI per ASTM F136. All the plates are Type II anodized. The plates incorporate both locking and nonlocking holes that allow the surgeon to stabilize the fracture by the use of compression plating techniques and then obtain neutralization of the construct with the locking screws. The locking screws construct can protect the compression screws while providing relative stability across extensive comminution of in osteopenic bone. The plate material and the inclusion of both locking and non-locking holes are design features also included in the predicate device cleared in K083843. The plates are designed to accept existing 2.7mm locking screws, 2.7mm non-
1 K083843 includes two families of plates. The subject device is claiming substantial equivalence to the Locking Composite Plate due to the similar size, shape and function.
2 See Section 14 for a listing of existing screws used in the Ulna Plating System.
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locking screws, and 2.7mm multidirectional screws. The non-locking and locking screws are manufactured from Titanium Alloy per ASTM F-136 and are color anodized. The multidirectional screws are manufactured from Cobalt Chromium Alloy per ASTM 1537. The predicate also includes Cobalt Chromium (ASTM F1537) multidirectional screws. The Ulna Plating System will offer the surgeon several system specific instruments as well as various general instruments to facilitate the installation of the implants.
Intended Use and Indications for Use
The System is indicated for fixation of fractures, osteotomies and non-unions of the ulna, particularly in osteopenic bone.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The Intended Use is similar to the Intended Use cleared in K083843.
- Indications for Use: The Indications for Use is similar to the Indications for Use cleared in K083843.
- Materials: The new Ulna Shortening System plates are manufactured from Type II anodized Titanium Alloy (Ti-6Al-4V ELI ASTM F136). The existing 2.7mm locking and non-locking screws included in the system are also manufactured from Titanium Alloy (Ti-6Al-4V ELI ASTM F136) and are either Type II anodized or color anodized. The system also contains existing 2.7mm multi-directional screws that are manufactured from Cobalt Chromium Alloy (ASTM F1537). Titanium alloys as well as implant grade cobalt chromium are commonly used materials in orthopeadic implants and are both used in the predicate device cleared via K083843. The patient contact instrumentation is comprised of stainless steel that meets ASTM F-899.
- Design Features: The design features for the Ulna Shortening System are similar to ● those in currently marketed devices cleared K083843. The design differences have not identified any issues that would impact the safety and effectiveness of the devices.
- . Sterilization: The implants and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use. The non-sterile packaging configuration is the same as the predicate devices currently marketed and cleared via K083843.
Summary of Performance Data (Nonclinical and/or Clinical)
- Non-Clinical Tests
- o Non-clinical performance testing included construct testing as well as 4-point bend testing per ASTM F382 to determine substantial equivalence of the Ulna Plating System. A Galvanic Corrosion engineering evaluation was also completed and was found to meet the acceptance criteria. Results indicate that the subject plating system is substantially equivalent to legally marketed devices.
- Clinical Tests
- No clinical tests are provided for basis of substantial equivalence. o
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Ulna Plating System | Traditional 510(k)
Substantial Equivalence Conclusion
The Ulna Plating System has shown to be substantially equivalent to the predicate devices. Results of non-clinical tests/engineering evaluation and the similarities with legally marketed predicated devices indicate the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.