(108 days)
No
The device description and intended use clearly define it as a mechanical internal fixation device (screws) with no mention of software, algorithms, or any AI/ML related functions. The performance studies are also focused on mechanical properties.
Yes
The device is intended for fixation, correction, or stabilization of bones, which are therapeutic actions to treat fractures and other conditions.
No
The device is described as an "internal fixation device" intended for the "fixation, correction or stabilization of small and long bones." Its function is structural support and repair, not the identification or analysis of diseases or conditions.
No
The device description clearly states it is an "internal fixation device that consists of various types of screws," which are physical hardware components.
Based on the provided information, the Stryker Fixos Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "fixation, correction or stabilization of small and long bones." This describes a surgical procedure and the use of an implantable device, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as an "internal fixation device that consists of various types of screws." This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Stryker Fixos Screw System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Fixos Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include:
Ø4.0mm Headless Screw:
- · Fractures of the tarsals and metatarsals
- · Fractures of the olecranon, distal humerus
- · Fractures of the radius and ulna
- · Patella fractures
- · Distal tibia and pilon fractures
- · Fractures of the fibula, medial malleolus, os calcis
- · Tarso-metatarsal and metatarsophalangeal arthrodesis
- · Metatarsal and phalangeal osteotomies
- · Osteochondritis dissecans
- · Fractures of the pelvic ring
- · Small cancellous fragments of the small and long bones
Ø5.0mm Headless Screw:
- · Medial and lateral malleolar and pilon fractures
- · Proximal and distal humerus fractures
- · Fractures of the olecranon process
- · Tibial plateau fractures
- · Os calcis, talar and patellar fractures
- · Fractures of the pelvis and acetabulum
- · Arthrodesis of the tarsals
07.0mm Headless Screw:
- Tibial plateau fractures
- Ankle arthrodesis
- · Calcaneus osteotomies
Product codes
87 HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Fixos Screw System. The Fixos Screw System is an internal fixation device that consists of various types of screws to treat a number of different types of fractures in small and long bones. The subject components will be available sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones, tarsals, metatarsals, olecranon, distal humerus, radius, ulna, patella, distal tibia, pilon, fibula, medial malleolus, os calcis, pelvis, acetabulum, ankle, calcaneus
Indicated Patient Age Range
adult and adolescent patients
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 laboratory testing was performed on the Fixos Screw System components to determine substantial equivalence. Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing.
The following testing was performed
- Insertion Torque Testing .
- Shear-off Testing .
- . Pull-out Testing
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
FEB 2 8 2014 Fixos Screw System Proprietary Name: Common Name: Bone Screws Classification Name and Reference: Smooth or threaded metallic bone fixation fastener 21 CFR §888.3040 Regulatory Class: Class II Product Codes: 87 HWC : Screw, Fixation, Bone Stryker Trauma AG Sponsor: Bohnackerweg 1 CH-2545 Selzach Switzerland Contact Person: Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-3461 estela.celi@stryker.com Date Prepared: November 7, 2013
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Fixos Screw System. The Fixos Screw System is an internal fixation device that consists of various types of screws to treat a number of different types of fractures in small and long bones. The subject components will be available sterile and non-sterile.
Intended Use
The Stryker Fixos Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients.
1
Indications
The Stryker Fixos Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include:
Ø4.0mm Headless Screw:
- · Fractures of the tarsals and metatarsals
- · Fractures of the olecranon, distal humerus
- · Fractures of the radius and ulna
- · Patella fractures
- · Distal tibia and pilon fractures
- · Fractures of the fibula, medial malleolus, os calcis
- · Tarso-metatarsal and metatarsophalangeal arthrodesis
- · Metatarsal and phalangeal osteotomies
- · Osteochondritis dissecans
- · Fractures of the pelvic ring
- · Small cancellous fragments of the small and long bones
Ø5.0mm Headless Screw:
- · Medial and lateral malleolar and pilon fractures
- · Proximal and distal humerus fractures
- · Fractures of the olecranon process
- · Tibial plateau fractures
- · Os calcis, talar and patellar fractures
- · Fractures of the pelvis and acetabulum
- · Arthrodesis of the tarsals
07.0mm Headless Screw:
- Tibial plateau fractures
- Ankle arthrodesis
- · Calcaneus osteotomies
Summarv of Technologies
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following predicate devices:
- Asnis III Cannulated Screw System-K000080 .
- . Darco Headless Compression Screw-K080850
- Synthes 4.5mm and 6.5mm Headless Compression Screws-K080943 .
2
Non-Clinical Testing
Non-clinical laboratory testing was performed on the Fixos Screw System components to determine substantial equivalence. Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing.
The following testing was performed
- Insertion Torque Testing .
- Shear-off Testing .
- . Pull-out Testing
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The Fixos Screw System is substantially equivalent to the predicate device identified in this premarket notification.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
February 28, 2014
Stryker Trauma AG Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K133451
Trade/Device Name: Fixos Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 28, 2014 Received: January 29, 2014
Dear Ms. Celi:
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
4
Page 2 - Ms. Estela Celi
(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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/Reportal/roblem/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/ResourcesforYou/Industry/default.hum.
Sincerely yours.
Vincent J. Devlin -S
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K133451
Device Name: Fixos Screw System
Indications for Use:
The Stryker Fixos Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include:
Ø4.0mm Headless Screw:
- · Fractures of the tarsals and metatarsals
- · Fractures of the olecranon, distal humerus
- Fractures of the radius and ulna
- · Patella fractures
- · Distal tibia and pilon fractures
- Fractures of the fibula, medial malleolus, os calcis
- · Tarso-metatarsal and metatarsophalangeal arthrodesis
- · Metatarsal and phalangeal osteotomies
- · Osteochondritis dissecans
- · Fractures of the pelvic ring
- · Small cancellous fragments of the small and long bones
05.0mm Headless Screw:
- · Medial and lateral malleolar and pilon fractures
- · Proximal and distal humerus fractures
- · Fractures of the olecranon process
- · Tibial plateau fractures
- Os calcis, talar and patellar fractures
- Fractures of the pelvis and acetabulum
- · Arthrodesis of the tarsals
07.0mm Headless Screw:
- · Tibial plateau fractures
- · Ankle arthrodesis
- · Calcaneus osteotomies
Over-The-Counter Use Prescription 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)
Elizabeth logrank -S
Division of Orthopedic Devices