(275 days)
INION OTPS™ Pin, Synthes® POLYPIN™ 2.0, Howmedica Bioabsorbable Pin, KLS-Martin, L.P. RESORB-X SF®
Not Found
No
The description focuses on the bioresorbable pin and ultrasonic insertion mechanism, with no mention of AI or ML.
Yes
The device is used to maintain alignment and fixation of bone fractures, osteotomies, or bone grafts, which directly treats a medical condition (hallux valgus). It is also described as being implanted into the body.
No
The device is described as an implant system (pins, generator, and sonotrode) used for maintaining alignment and fixation of bone fractures, osteotomies, or bone grafts, specifically for hallux valgus correction. Its function is to treat a condition, not to diagnose it.
No
The device description clearly states the system consists of a bioresorbable implant pin (hardware) and an ultrasonic unit (hardware), in addition to any potential software components.
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.
- Stryker SonicPin™ System Function: The description clearly states that the Stryker SonicPin™ System is used to maintain alignment and fixation of bone fractures, osteotomies, or bone grafts in hallux valgus applications. It is a surgical implant and the associated tools for its insertion.
- No Sample Analysis: The device does not analyze any samples taken from the body. Its function is purely mechanical/surgical.
Therefore, based on the provided information, the Stryker SonicPin™ System falls under the category of a surgical device or implant, not an In Vitro Diagnostic.
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, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.
Product codes
87 HTY
Device Description
The Stryker SonicPin™ System consists of a bioresorbable implant pin made of a PLDLA copolymer and an ultrasonic unit (generator and sonotrode). Pins are implanted using ultrasonic energy generated by an ultrasonic unit, allowing the pin to adapt to the previously drilled hole. Its intended use is the correction of the Hallux Valgus deformation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures, osteotomies, or bone grafts in hallux valgus applications
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
INION OTPS™ Pin, Synthes® POLYPIN™ 2.0, Howmedica Bioabsorbable Pin, KLS-Martin, L.P. RESORB-X SF®
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
1091955 510(k) Summary of Safety and Effectiveness Stryker SonicPin™ System
APR - 2 2010
| Proprietary Name: | Stryker SonicPin™ System |
|---|---|
| Common Name: | Smooth Fixation Pin |
| Classification Name/Reference: | Smooth or threaded metallic bone fixation fastener, 21 CFR |
| $888.3040 | |
| Device Product Code: | 87 HTY |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Avital Merl-Margulies |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6365 Fax: (201) 831-3365 | |
| Date Summary Prepared. | February 1 2010 |
Description:
The Stryker SonicPin™ System consists of a bioresorbable implant pin made of a PLDLA copolymer and an ultrasonic unit (generator and sonotrode). Pins are implanted using ultrasonic energy generated by an ultrasonic unit, allowing the pin to adapt to the previously drilled hole. Its intended use is the correction of the Hallux Valgus deformation.
Indications:
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, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.
Substantial Equivalence:
The Stryker SonicPin™ System is substantially equivalent to the INION OTPS™ Pin, Synthes® POLYPIN™ 2.0, Howmedica Bioabsorbable Pin, as well as the KLS-Martin, L.P. RESORB-X SF® in regards to intended use, indications for use, technological characteristics, design, materials, and operational principles as a fracture fixation system.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies 325 Corporate Drive Mahwah, NJ 07430
APR - 2 2010
Re: K091955
Trade/Device Name: Stryker SonicPin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: I-ITY Dated: February 1, 2010 Received: February 2, 2010
Dear Ms. Merl-Margulies:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Avital Merl-Margulies
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark M. Milkean
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 109 j955
Device Name: Stryker SonicPin™ Pin System
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, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Mark A. Millum
(Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091953