Anchorage Bone Plating System

K172148 · Stryker GmbH · HRS · Mar 19, 2018 · Orthopedic

Device Facts

• Record ID: K172148
• Device Name: Anchorage Bone Plating System
• Applicant: Stryker GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Mar 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Anchorage Bone Plating System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hands, feet, wrists, and toes. The system may be used in adults and pediatric patients.

Device Story

Anchorage Bone Plating System consists of single-use titanium alloy bone plates and 3mm or 3.5mm screws; intended for permanent implantation. Plates feature varying curvatures, lengths, thicknesses, and hole configurations designed to prevent screw contact. Used by surgeons in clinical settings for fracture fixation, joint fusion, and reconstruction of small bones. Device provides mechanical stabilization of bone segments to facilitate healing. No software or electronic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy bone plates and screws; 3mm or 3.5mm screw diameters; various plate geometries (curvature, length, thickness, hole count). Mechanical fixation via bone screws. Non-sterile/sterile (implied single-use).

Indications for Use

Indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in hands, feet, wrists, ankles, fingers, and toes in adult and pediatric patients.

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

• Anchorage Bone Plating System (K083477)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Public Health Service

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

March 19, 2018

Stryker GmbH Jackie Perri Institutional Review Board Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K172148

Trade/Device Name: Anchorage Bone Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: July 14, 2017 Received: July 17, 2017

Dear Jackie Perri:

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

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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 (DICE) 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" (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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

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) K172148

Device Name Anchorage Bone Plating System

Indications for Use (Describe)

The Anchorage Bone Plating System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hands, feet, wrists, and toes. The system may be used in adults and pediatric patients.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K172148 Page 1/2

#### 510(k) Summary

| Proprietary Name: | Anchorage Bone Plating System |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Plate/Screw, Fixation, Bone |
| Regulation Description: | Single/Multiple component metallic fixation bone fixation<br>appliance and accessories |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | HRS (Plate, Fixation, Bone)<br>HWC (Screw, Fixation, Bone) |
| Device Class: | Class II |
| Sponsor: | Stryker Trauma AG<br>Bohnackerweg l<br>2545 Selzach / Switzerland |
| Contact Person: | Jackie Perri<br>IRB Specialist, Regulatory Affairs<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 13, 2017 |
| Primary Predicate: | Anchorage Bone Plating System (K083477) |

## Description

The Anchorage Bone Plating System includes single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made from titanium alloy. The Anchorage Bone Plating System uses either a 3 mm or 3.5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary in curvature, length, thickness, number of holes, and plate shape. The Anchorage Bone Plating System is intended for fracture fixation.

## Indications for Use

The Anchorage Bone Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the hands, feet, wrists, ankles, fingers, and toes. The system may be used in adults and pediatric patients.

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Stryker GmbH Anchorage Bone Plating System

## Summary of Technologies

A comparison of the systems demonstrated that the subject Stryker Anchorage Bone Plating System is substantially equivalent to the predicate Memometal Anchorage Bone Plating System (K083477) in regards to intended use, material, design, and operational principles.

# Non-Clinical Testing

Non-clinical laboratory testing was performed on the worst case subject screws to determine substantial equivalence. Mechanical testing was performed and demonstrated that Stryker Anchorage Bone Plating System is equivalent in mechanical performance to the predicate device, the Memometal Anchorage Bone Plating System (K083477).

The following testing was performed:

- . Cantilever bending
- Torque to failure ●
- . Push-Out
- Shear-off ●

# Clinical Testing

Clinical testing was not required for this submission.

## Conclusion

The subject Stryker Anchorage Bone Plating System is substantially equivalent to the predicate Memometal Anchorage Bone Plating System.