(127 days)
Not Found
No
The summary describes a bioresorbable pin and an ultrasound-based insertion system, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to maintain alignment and fixation of bone fractures, osteotomies, or bone grafts, which directly addresses a medical condition (hallux valgus applications) and provides an active therapeutic effect.
No
The device is described as an implantable pin system used for fixation of bone fractures and osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of a sterile bioresorbable pin (implant) and SonicFusion equipment, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications." This is a therapeutic and structural function within the body.
- Device Description: The device is an implantable bioresorbable pin used for bone fixation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is clearly a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.
Product codes
HTY
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the modified bioresorbable pin (implant) of Stryker SonicPin System. Modifications include changes of raw material specification for PLDLLA, concentration of color additive, packaging material, shelf life, storage conditions, and labeling documents. Multiple changes occurred by manufacturing.
The Stryker SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization.
The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.
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
Mechanical testing was performed to evaluate the mechanical performance:
- Static shear strength testing
Testing demonstrated that Stryker SonicPin System is equivalent in mechanical performance to the predicate device (K143063). Further, the polymer characterization (for the raw material and final, finished device) and the in vitro degradation curve were performed.
Additionally, the magnetic resonance safety and compatibility were evaluated according to FDA Guidance 'Establishing safety and compatibility of passive implants in the magnetic resonance (MR) environment' (2014). The scientifically based rationale demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System can be used in MR environment and is labeled as 'MR safe'.
Biocompatibility testing was performed to evaluate the biological safety of Stryker SonicPin System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. The following testing was performed:
- Chemical characterization according to ISO 10993-18 .
- Cytotoxicity testing according to ISO 10993-5
- Biological and chemical risk assessment .
Testing demonstrated that Stryker SonicPin System is biocompatible.
The Bacterial Endotoxin Testing (BET) was performed and demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System meets the specified endotoxin limit.
Key Metrics
Not Found
Predicate Device(s)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2017
Stryker Trauma GmbH Dr. Heike Gustke Staff Regulatory Affairs Specialist. Trauma & Extremities Prof-Kuentscher-Str. 1-5 Schoenkirchen, DE 24232 Germany
Re: K170418
Trade/Device Name: Stryker SonicPin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: May 16, 2017 Received: May 24, 2017
Dear Dr. Gustke:
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
1
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 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 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,
Mark N. Melkerson -S
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)
Device Name Stryker SonicPin System
Indications for Use (Describe)
The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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FORM FDA 3881 (8/14)
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3
| 7 510(k) Summary | |
|---|---|
| Proprietary Name: | Stryker SonicPin System |
| Common Name: | Pin, fixation, smooth |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HTY |
| Device Class: | Class II |
| Sponsor: | Stryker Trauma GmbH |
| Prof.-Kuentscher-Str. 1-5 | |
| 24232 Schoenkirchen / Germany | |
| Contact Person: | Dr. Heike Gustke |
| Staff Regulatory Affairs Specialist | |
| Prof.-Kuentscher-Str. 1-5 | |
| 24232 Schoenkirchen / Germany | |
| heike.gustke@stryker.com | |
| Phone: +49 4348 702 637 | |
| Fax: +49 4348 702 8637 | |
| Date Prepared: | June 6, 2017 |
| Primary Predicate: | Stryker SonicPin System (K143063) |
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the modified bioresorbable pin (implant) of Stryker SonicPin System. Modifications include changes of raw material specification for PLDLLA, concentration of color additive, packaging material, shelf life, storage conditions, and labeling documents. Multiple changes occurred by manufacturing.
4
The Stryker SonicPin System consists of a sterile bioresorbable pin (implant), the SonicFusion equipment as well as associated accessories and is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization.
The bioresorbable pin is implanted by the controlled application of ultrasound (SonicFusion technology). The ultrasonic energy is employed to liguefy the polymeric interface between the implant and the host bone to ensure a strong fixation with the bone after solidification.
Intended Use
The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.
Indications for Use
The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.
Summary of Technologies
Device comparison demonstrated that the subject device is substantially equivalent to the previously cleared Stryker SonicPin System (K143063) in regards to intended use, indications for use, design, and operational principles as well as similar in regard to material.
Non-Clinical Test
Non-clinical laboratory testing was performed on Stryker SonicPin System under worst case scenario to determine substantial equivalence.
Mechanical testing was performed to evaluate the mechanical performance:
- Static shear strength testing
5
Testing demonstrated that Stryker SonicPin System is equivalent in mechanical performance to the predicate device (K143063). Further, the polymer characterization (for the raw material and final, finished device) and the in vitro degradation curve were performed.
Additionally, the magnetic resonance safety and compatibility were evaluated according to FDA Guidance 'Establishing safety and compatibility of passive implants in the magnetic resonance (MR) environment' (2014). The scientifically based rationale demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System can be used in MR environment and is labeled as 'MR safe'.
Biocompatibility testing was performed to evaluate the biological safety of Stryker SonicPin System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. The following testing was performed:
- Chemical characterization according to ISO 10993-18 .
- Cytotoxicity testing according to ISO 10993-5
- Biological and chemical risk assessment .
Testing demonstrated that Stryker SonicPin System is biocompatible.
The Bacterial Endotoxin Testing (BET) was performed and demonstrated that the modified bioresorbable pin (implant) of Stryker SonicPin System meets the specified endotoxin limit.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
Modifications made to the Stryker SonicPin System have been evaluated in comparison to the predicate device and non-clinical data have been used to support substantial equivalence.
The Stryker SonicPin System is substantially equivalent to the predicate device identified in this premarket notification.