APTUS(R) Wrist 2.5 System

K172170 · Medartis AG · HRS · Sep 8, 2017 · Orthopedic

Device Facts

• Record ID: K172170
• Device Name: APTUS(R) Wrist 2.5 System
• Applicant: Medartis AG
• Product Code: HRS · Orthopedic
• Decision Date: Sep 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.

Device Story

APTUS® Wrist 2.5 System consists of metallic bone plates and compatible screws for orthopedic fixation. Plates are pre-contoured for left and right distal radius anatomy (Lunate Facet and Distal Radius Rim designs). Device is used by orthopedic surgeons in clinical settings to stabilize bone fractures, osteotomies, or arthrodeses. Plates are implanted via surgical procedure; screws provide locking or non-locking fixation to bone. System provides mechanical stability to bone segments during healing; benefits include anatomical alignment and rigid fixation. Device is provided non-sterile; requires end-user sterilization.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including engineering analysis, static mechanical testing per ASTM F382, and dynamic fatigue testing in a simulated fracture model.

Technological Characteristics

Materials: Unalloyed titanium Grade 4 (ASTM F67) for plates; Ti-6Al-4V alloy (ASTM F136) for screws. Design: Pre-contoured anatomic plates (1.6-1.8 mm thickness). Mechanical: Locking and non-locking screw fixation. Sterilization: Non-sterile, end-user sterilized. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring fixation for hand and forearm fractures, osteotomies, and arthrodeses.

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

• APTUS® Wrist 2.5 System (K142906)
• APTUS® Titanium System (K051567)

Reference Devices

• K103332
• K092038

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.

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

September 8, 2017

Medartis AG % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K172170

Trade/Device Name: APTUS® Wrist 2.5 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 17, 2017 Received: July 18, 2017

Dear Kevin Thomas:

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

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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 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,

# 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K172170

Device Name

APTUS® Wrist 2.5 System

Indications for Use (Describe)

APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) Summary

## Medartis AG

# APTUS® Wrist 2.5 System

July 17, 2017

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Medartis AG<br>Hochbergerstrasse 60E<br>CH-4057 Basel, Switzerland |
|-------------------|--------------------------------------------------------------------|
| | Telephone: [phone]<br>Fax: [phone] |
| Official Contact | Andrea Schweizer<br>Head of Quality Management |

Representative/Consultant Kevin A. Thomas, PhD Floyd G. Larson, MS, MBA PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail]

## DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | APTUS® Wrist 2.5 System |
|----------------------------|--------------------------------------------------------------------------------|
| Common Name | Plate, fixation, bone |
| Classification Names | Single/multiple component metallic bone fixation appliances<br>and accessories |
| Classification Regulations | 21 CFR 888.3030 |
| Product Codes | HRS |
| Classification Panel | Orthopedic Products Panel |
| Reviewing Branch | Joint Fixation Devices Branch Two (JFDB2) |

#### PREDICATE DEVICE INFORMATION

The primary predicate device is K142906. The reference predicate device is K051567.

#### INDICATIONS FOR USE

APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, and arthrodeses.

#### SUBJECT DEVICE DESCRIPTION

The subject device plates have anatomic designs and are provided in two designs, each for the left and right radius: Lunate Facet Plate and Distal Radius Rim Plate. The Lunate Facet Plates have a maximum thickness of 1.6 mm, and maximum overall dimensions of approximately 19 mm x 47 mm before bending to conform to the anatomy of the distal radius. The Distal Radius Rim Plates have a maximum thickness of 1.8 mm, and maximum overall dimensions of approximately 22 mm x 53 mm before bending to

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510(k) Summary Page 2 of 3

conform to the anatomy of the distal radius. The screw holes of the subject device plates are designed to accommodate appropriately sized bone screws (locking and non-locking) presently marketed as part of the APTUS System and previously cleared under K142906, K103332, and K051567. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of unalloved titanium. Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

## PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K142906), engineering analysis, static mechanical testing (according to ASTM F382), and dynamic mechanical testing of the subject and predicate plate designs in a simulated fracture model. Clinical data were not provided in this submission.

# EQUIVALENCE TO MARKETED DEVICE

Medartis AG submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K142906, APTUS® Wrist 2.5 System, Medartis AG

K051567, APTUS® Titanium System, Medartis, Inc.

A comparison of the technological characteristics of the subject device and the primary predicate device K142906 is provided in the following table.

| Comparison | Subject Device | Primary Predicate Device |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | APTUS Wrist 2.5 System<br>Medartis AG | K142906<br>APTUS Wrist 2.5 System<br>Medartis AG |
| Indications for Use<br>Statement | APTUS® Wrist 2.5 System is intended for use in hand<br>and forearm fractures, osteotomies, and arthrodeses. | APTUS® Wrist 2.5 System is intended for use in hand<br>and forearm fractures, osteotomies and arthrodeses. |
| Device Characteristics | | |
| Plate Designs | Anatomic plate designs (n=2) for left and right radius<br>Lunate Facet Plate and Distal Radius Rim Plate | Anatomic plate designs (multiple) for left and right<br>radius |
| Plate Thickness | Lunate Facet Plate – 1.6 mm<br>Distal Radius Rim Plate - 1.8 mm | 0.6 mm to 3.2 mm |
| Plate Overall Dimensions<br>(approximate) | Lunate Facet Plate - 19 mm width x 47 mm length<br>Distal Radius Rim Plate – 22 mm width x 53 mm<br>length | Width: 7 mm to 36 mm<br>Length: 7 mm to 184 mm |
| Plate Material | Unalloyed titanium, grade 4 (ASTM F67) | Unalloyed titanium, grade 4 (ASTM F67) |
| Information below for Subject Device is for previously cleared compatible screws | | |
| Screw Designs | Self-drilling and self-tapping;<br>Cortical (conventional non-locking) and locking | Self-drilling and self-tapping;<br>Cortical (conventional non-locking) and locking |
| Screw Diameter | 1.5 mm and 2.5 mm | 1.5 mm and 2.5 mm |
| Screw Length | 8 mm to 34 mm | 8 mm to 34 mm |
| Screw Material | Ti-6Al-4V alloy (ASTM F136) | Ti-6Al-4V alloy (ASTM F136) |

The subject device and the predicate device have the same intended use and the same Indications for Use statement.

The subject device and predicate device plates have the same technological characteristics are fabricated from the same materials and share similar design characteristics, including plate screw holes to accommodate locking and non-locking screws. The subject device and predicate device plates also are

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provided in pre-contoured designs for the left and right radius, and encompass a similar range of physical dimensions appropriate to the anatomy. Any minor differences in the technological characteristics between the subject device and the predicate device do not raise new issues of safety or efficacy.

The subject device and predicate device plates are provided non-sterile and are to be sterilized by the enduser. The subject device components are packaged using the same materials and are to be sterilized by the same methods as the predicate device.

All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the predicate device components cleared in K142906, and therefore are substantially equivalent to the predicate device regarding biocompatibility.

Performance data provided to demonstrate substantial equivalence included engineering analysis, single cvcle bending and bending fatigue testing of the subject device and predicate device plates. In addition, in a simulated fracture models, the dynamic (fatigue) performance of the subject device constructs was superior to that of the predicate device constructs.

Differences between the subject device and predicate device plates include differently shaped anatomic designs for the distal radius. The subject device and predicate device plates have a similar overall shape and similar maximum plate thickness (subject device plates 1.6 mm, predicate plates 1.6 mm and 2.0 mm). Substantial equivalence is supported by the mechanical testing of the subject device and predicate device plate and screw constructs.

# CONCLUSION

The subject device and the predicate device plates have the same intended use, have similar technological characteristics, and are made of the same material. The subject device and predicate device plates also are provided in pre-contoured anatomic designs for the left and right radius, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and predicate device components are packaged in similar materials and are to be sterilized by the end-user using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices K142906 and K051567.