AxSOS 3Ti

K153379 · Stryker GmbH · HRS · May 26, 2016 · Orthopedic

Device Facts

• Record ID: K153379
• Device Name: AxSOS 3Ti
• Applicant: Stryker GmbH
• Product Code: HRS · Orthopedic
• Decision Date: May 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: - Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures - Non-unions and malunions - Normal and osteopenic bone - Osteotomies - Periprosthetic fractures of the femur and proximal tibia The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: - Periprosthetic fractures - Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

Device Story

AxSOS 3 Ti is a metallic bone fixation system consisting of plates and screws; used by orthopedic surgeons for fracture stabilization. System includes monoaxial plates and screws; introduces 4.0mm and 5.0mm waisted compression plates and blind screws. Device provides mechanical support to bone segments to facilitate healing; used in clinical settings. Surgeon selects appropriate plate/screw configuration based on fracture site and patient anatomy; implants are secured to bone to maintain alignment during healing process. Benefits include stabilization of fractures, non-unions, and malunions in both adult and pediatric populations.

Clinical Evidence

No clinical data. Bench testing only; engineering analysis performed comparing subject device to predicate devices.

Technological Characteristics

Materials: Ti-6Al-4V (ASTM F-136 ELI). Components: Monoaxial bone plates (waisted compression) and bone screws (including blind screws). Dimensions: 4.0mm and 5.0mm plate widths, various lengths/hole counts. Mechanical fixation principle. Sterilization: Not specified.

Indications for Use

Indicated for long bone fracture fixation in patients with diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures, non-unions, malunions, osteotomies, and periprosthetic fractures of femur/tibia. Includes pediatric patients for waisted compression plates and scapula/pelvis fixation for 4mm plates. Suitable for normal and osteopenic bone.

Regulatory Classification

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.

Predicate Devices

• AxSOS 3 Ti Locking Plate System (K141121)
• AxSOS 3 Ti Locking Plate System (K143138)
• OrthoHelix Surgical Design (K113048)
• OrthoHelix Surgical Design (K122005)
• OrthoHelix Surgical Design (K132591)

Reference Devices

• Zimmer NCB Blind Screw Insert (K113718)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2016

Stryker GmbH Saad Attiyah Senior Regulatory Affairs Manager Bohnackerweg 1 2545 Selzach, CH 2545 SWITZERLAND

Re: K153379 Trade/Device Name: AxSOS 3 Ti Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 25, 2016 Received: April 26, 2016

Dear Saad Attiyah:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [phone] or [phone] 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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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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### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153379

Device Name AxSOS 3 Ti

Indications for Use (Describe)

AxSOS 3 Ti is intended for long bone fracture fixation.

Indications include:

- · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia

The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:

- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients.

The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.

Type of Use (Select one or both, as applicable)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## Section 7. 510(k) Summary

| Submitter: | Stryker GmbH<br>Bohnackerweg 1<br>2545 Selzach<br>Switzerland |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Saad Attiyah<br>Senior Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone] |
| Establishment Number<br>Date Prepared: | 8031020<br>May 24, 2016 |
| Name of Device: | AxSOS 3 Ti |
| Common or Usual Name | Bone Plates<br>Bone Screws |
| Classification Name: | Single/multiple component metallic<br>bone fixation<br>Appliance and accessories |
| | 21 CFR §888.3030 |
| | Smooth or threaded metallic bone<br>fixation fastener |
| Regulatory Class: | 21 CFR §888.3040<br>II |
| Product Codes: | HRS: Plate, Fixation, Bone<br>HWC: Screw, Fixation, Bone |
| Predicate Device: | AxSOS 3 Ti Locking Plate System<br>(K141121)<br>AxSOS 3 Ti Locking Plate System<br>(K143138)<br>OrthoHelix Surgical Design (K113048,<br>K122005, K132591) |
| Reference Device: | Zimmer NCB Blind Screw Insert<br>(K113718) |

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The AxSOS 3 Ti Locking Plate System is

intended for long bone fracture fixation Indications for Use: AxSOS 3 Ti is intended for long bone fracture fixation. Indications include: · Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures • Non-unions and malunions · Normal and osteopenic bone · Osteotomies · Periprosthetic fractures of the femur and proximal tibia The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: · Periprosthetic fractures • Diaphyseal and metaphyseal areas of long bones in pediatric patients. The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis. Description: The AxSOS 3 Ti Plating System consists of various monoaxial plates and screws made from Ti-6AI-4V (ASTM F-136 ELI). The system contains previously cleared distal lateral femur plates, proximal lateral tibial plates, distal anterolateral tibia plates, distal medial plates, proximal medial tibia plates and proximal humerus plates provided in various lengths (K123964, K133440, K141121, and K143138). This premarket notification introduces 4.0 mm waisted compression plates and 5.0 mm broad

Intended Use:

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| | K153379 | Pg.3/3 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | and narrow waisted compression<br>plates in various lengths and number of<br>holes.<br>The system contains previously cleared<br>screws with various lengths and<br>diameters and provided in various<br>configurations (fully or partially<br>threaded) identified in previously<br>cleared premarket notifications<br>(K123964, K133440, K141121, and<br>K143138). This premarket notification<br>introduces blind screws used with the<br>4.0 mm and 5.0 mm waisted<br>compression plates. | |
| Bench Testing: | An engineering analysis was performed<br>comparing the specific predicate<br>devices. | |
| Animal Testing: | Animal testing was not required for this<br>submission. | |
| Clinical Testing: | Clinical testing was not required for this<br>submission. | |
| Substantial Equivalence Statement: | Documentation is provided which<br>demonstrates that the AxSOS 3 Ti is<br>substantially equivalent to its predicate<br>and reference devices in terms of its<br>material, design, and indications for<br>use, and performance characteristics. | |