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

Device Description

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.

AI/ML Overview

This submission is for the Fixos Screw System, a bone fixation device, and does not involve AI or algorithms that would require a study with acceptance criteria as typically defined for AI/ML devices. Therefore, a table of acceptance criteria and reported device performance related to AI/ML is not applicable. Similarly, most of the requested points are not relevant to this type of medical device submission.

Here's an analysis based on the provided text, highlighting why most points are not pertinent:

1. Table of Acceptance Criteria and Reported Device Performance (AI/ML specific): Not Applicable
This product is a traditional medical device (bone screws), not an AI/ML diagnostic or therapeutic device. Acceptance criteria for such devices typically relate to engineering specifications, material properties, and mechanical performance, not AI-driven metrics like sensitivity, specificity, or F1-score. The document states "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing." This implies that the performance met the expected standards for a bone screw, which would be based on mechanical tests, not AI-specific metrics.

2. Sample Size for the Test Set and Data Provenance (AI/ML specific): Not Applicable
No "test set" in the context of AI/ML models was used. The non-clinical testing involved mechanical tests on the device components themselves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (AI/ML specific): Not Applicable
Ground truth established by experts is a concept relevant to AI model training and evaluation, particularly for image analysis or diagnostic tasks. This device is a physical implant, not a diagnostic tool requiring expert ground truth for its performance assessment.

4. Adjudication Method (AI/ML specific): Not Applicable
Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert labeling or diagnoses, which is a process specific to establishing ground truth for AI model development and validation. This is not relevant to the mechanical testing of a bone screw.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (AI/ML specific): No
The document explicitly states "Clinical testing was not required for this submission." MRMC studies are typically used to evaluate the impact of AI on human reader performance in diagnostic tasks. Since this is a physical device and no clinical testing was performed, an MRMC study was not conducted.

6. Standalone (Algorithm Only) Performance (AI/ML specific): Not Applicable
This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used (AI/ML specific): Not Applicable
Ground truth (expert consensus, pathology, outcomes data) is used to validate AI systems. For a bone screw, the "ground truth" for its performance would be its mechanical integrity and biocompatibility, assessed through laboratory testing and material science, not through these types of data.

8. Sample Size for the Training Set (AI/ML specific): Not Applicable
There is no "training set" for an AI model as this is a physical device.

9. How the Ground Truth for the Training Set Was Established (AI/ML specific): Not Applicable
Again, this product is a physical device, not an AI model, so there is no training set or ground truth in that context.

Summary Relevant to the Provided Document:

Acceptance Criteria: For the Fixos Screw System, acceptance criteria were based on non-clinical laboratory testing demonstrating substantial equivalence to predicate devices in terms of mechanical performance. These tests included:
- Insertion Torque Testing
- Shear-off Testing
- Pull-out Testing
  The success criteria for these tests would typically be that the new device's performance falls within a predefined range that is equivalent to or better than the predicate devices, ensuring its mechanical integrity and strength for its intended use. The document confirms that "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing."
Study Proving Acceptance: The study involved non-clinical laboratory testing of the Fixos Screw System components. The study's conclusion was that the device is "substantially equivalent to the predicate device identified in this premarket notification." The specific details of the exact values or thresholds for "substantial equivalence" are not provided in this summary but would be part of the full 510(k) submission.

In essence, the Fixos Screw System is a traditional medical device, and its evaluation for market clearance followed the standard path for such devices by demonstrating substantial equivalence through non-clinical mechanical testing when compared to already cleared predicate devices. AI/ML-specific validation criteria and studies are not applicable here.

Summary

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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.

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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 .

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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.

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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

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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

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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

Regulation Number and Section

§ 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.