(245 days)
The Anchorage Bone Plating System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hands, feet, wrists, and toes. The system may be used in adults and pediatric patients.
The Anchorage Bone Plating System includes single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made from titanium alloy. The Anchorage Bone Plating System uses either a 3 mm or 3.5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary in curvature, length, thickness, number of holes, and plate shape. The Anchorage Bone Plating System is intended for fracture fixation.
The provided text is a 510(k) summary for the Stryker Anchorage Bone Plating System. This document describes a medical device, its indications for use, and how it was determined to be substantially equivalent to a previously marketed device.
Crucially, this document specifies:
"Clinical testing was not required for this submission."
Therefore, based solely on the provided text, there is no information available regarding a study that proves the device meets acceptance criteria related to clinical performance or AI/software algorithm performance. The substantial equivalence determination was based on non-clinical mechanical testing.
As such, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of an AI/software algorithm.
If this was a misunderstanding and you were expecting information about the mechanical acceptance criteria and how the non-clinical testing proved the device meets them, I can extract that to a limited extent:
Information based on Non-Clinical Testing Section:
- Acceptance Criteria (Implied): Mechanical performance equivalent to the predicate device, the Memometal Anchorage Bone Plating System (K083477).
- Reported Device Performance: "Mechanical testing was performed and demonstrated that Stryker Anchorage Bone Plating System is equivalent in mechanical performance to the predicate device, the Memometal Anchorage Bone Plating System (K083477)."
- Tests Performed:
- Cantilever bending
- Torque to failure
- Push-Out
- Shear-off
However, the document does not provide any specific quantitative acceptance criteria values, sample sizes for these tests, or detailed results. It only states that equivalence was demonstrated.
Therefore, I cannot fulfill your request for the comprehensive table and detailed study information as it pertains to AI/software performance or detailed quantitative mechanical performance data, because the provided text explicitly states "Clinical testing was not required for this submission" and does not describe such a study.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of an eagle with three human profiles incorporated into its design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2018
Stryker GmbH Jackie Perri Institutional Review Board Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K172148
Trade/Device Name: Anchorage Bone 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: July 14, 2017 Received: July 17, 2017
Dear Jackie Perri:
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
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (DICE) 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 (DICE) 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K172148
Device Name Anchorage Bone Plating System
Indications for Use (Describe)
The Anchorage Bone Plating System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hands, feet, wrists, and toes. The system may be used in adults and pediatric patients.
| 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K172148 Page 1/2
510(k) Summary
| Proprietary Name: | Anchorage Bone Plating System |
|---|---|
| Common Name: | Plate/Screw, Fixation, Bone |
| Regulation Description: | Single/Multiple component metallic fixation bone fixationappliance and accessories |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | HRS (Plate, Fixation, Bone)HWC (Screw, Fixation, Bone) |
| Device Class: | Class II |
| Sponsor: | Stryker Trauma AGBohnackerweg l2545 Selzach / Switzerland |
| Contact Person: | Jackie PerriIRB Specialist, Regulatory Affairs325 Corporate DriveMahwah, NJ 07430Phone: (732) 770-5616Fax: (201) 831-3802 |
| Date Prepared: | June 13, 2017 |
| Primary Predicate: | Anchorage Bone Plating System (K083477) |
Description
The Anchorage Bone Plating System includes single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made from titanium alloy. The Anchorage Bone Plating System uses either a 3 mm or 3.5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary in curvature, length, thickness, number of holes, and plate shape. The Anchorage Bone Plating System is intended for fracture fixation.
Indications for Use
The Anchorage Bone Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hands, feet, wrists, ankles, fingers, and toes. The system may be used in adults and pediatric patients.
{4}------------------------------------------------
Stryker GmbH Anchorage Bone Plating System
Summary of Technologies
A comparison of the systems demonstrated that the subject Stryker Anchorage Bone Plating System is substantially equivalent to the predicate Memometal Anchorage Bone Plating System (K083477) in regards to intended use, material, design, and operational principles.
Non-Clinical Testing
Non-clinical laboratory testing was performed on the worst case subject screws to determine substantial equivalence. Mechanical testing was performed and demonstrated that Stryker Anchorage Bone Plating System is equivalent in mechanical performance to the predicate device, the Memometal Anchorage Bone Plating System (K083477).
The following testing was performed:
- . Cantilever bending
- Torque to failure ●
- . Push-Out
- Shear-off ●
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject Stryker Anchorage Bone Plating System is substantially equivalent to the predicate Memometal Anchorage Bone Plating System.
§ 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.