MICRONAIL Distal Radius System

K150073 · Wrightmedicaltechnologyinc · HSB · Feb 10, 2015 · Orthopedic

Device Facts

• Record ID: K150073
• Device Name: MICRONAIL Distal Radius System
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HSB · Orthopedic
• Decision Date: Feb 10, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MICRONAIL® Intramedullary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable: • Joint destruction and/or subluxation visible on x-ray; • Failed fracture fixation with or without bone graft; • Osteotomy and repair of distal radius malunion with or without bone graft; • Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone; • Comminuted articular fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with or with or with or without an external fixator.

Device Story

Intramedullary fixation system for distal radius fractures; consists of radial nail, cortical bone screws, buttress pins, and buttress screws. Used by orthopedic surgeons in clinical settings to stabilize fractures where closed reduction fails. Device components implanted to provide internal fixation; supports bone healing. Subject device represents modifications to previously cleared system (K040938), including design changes to nails and screws and availability of sterile/non-sterile options.

Clinical Evidence

No clinical data provided; substantial equivalence supported by non-clinical mechanical testing and FEA analysis.

Technological Characteristics

Intramedullary fixation rod system. Materials: Titanium alloy (Ti 6Al-4V-ELI). Components: Radial nail, cortical bone screws, buttress pins, buttress screws. Sterilization: Updated methods for sterile and non-sterile configurations.

Indications for Use

Indicated for patients with unstable distal radius fractures where closed reduction is unsuitable, including joint destruction/subluxation, failed prior fixation, malunion requiring osteotomy, displaced/non-displaced fractures, and comminuted articular or extra-articular fractures.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Radial Nail System (K040938)

Submission Summary (Full Text)

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

Wright Medical Technology, Incorporated Ms. Jeanine Redden Regulatory Affairs Director 1023 Cherry Road Memphis, Tennessee 38117

February 10, 2015

Re: K150073

Trade/Device Name: MICRONAIL® Distal Radius System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 8, 2015 Received: January 14, 2015

Dear Ms. Redden:

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

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Page 2 - Ms. Jeanine Redden

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/Resourcesfor You/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 vours.

# 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

510(k) Number (if known)

# K150073

Device Name MICRONAIL® Distal Radius System

## Indications for Use (Describe)

The MICRONAL® Intramedulary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

• Joint destruction and/or subluxation visible on x-ray;

- · Failed fracture fixation with or without bone graft;
- · Osteotomy and repair of distal radius malunion with or without bone graft;
- · Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone;
- · Comminuted articular fractures of the articular surface, severely comminuted extra-articular fractures, and

fractures in which reduction has been lost following fixation with or with or with or without an external fixator.

## 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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Expiration Date: January 31, 2017 See PRA Statement on last page.

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K150073 Page 1 of 2

Headquarters Wright Medical Technology, Inc.

1023 Cherry Road Memphis, TN 38117

901 867 9971 wmt.com

Image /page/4/Picture/4 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, sans-serif font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name and a tagline that emphasizes quality.

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the MICRONAIL™ Distal Radius System.

| 1. Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Rd. Memphis, TN 38117 |
|------------------------------------|----------------------------------------------------------------------------------------------------------|
| Date: | February 9, 2015 |
| Contact Person: | Jeanine Redden Director, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail] |
| 2. Proprietary Name: | MICRONAIL ^TM Distal Radius System |
| Common Name: | Intramedullary fixation rod |
| Classification Name and Reference: | 21 CFR 888.3020- Class II |
| Device Product Code, Device Panel: | HSB - Orthopedic |

### 3. Predicate Device:

K040938 Radial Nail System

### Device Description 4.

The MICRONAIL™ Distal Radius System was cleared (K040938) as a system consisting of a radial nail, cortical bone screws, buttress pins, and buttress screws. All components are manufactured from titanium alloy, Ti 6Al-4V-ELI. Changes to the subject devices include changes made to the radial nail, buttress screws, and cortical bone screws and availability of sterile and non-sterile devices.

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### 5. Intended Use

The MICRONAIL® Intramedullary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

- · Joint destruction and/or subluxation visible on x-ray;
- · Failed fracture fixation with or without bone graft;
- · Osteotomy and repair of distal radius malunion with or without bone graft;
- · Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone;
- · Comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

### Technological Characteristics Comparison 6.

The MICRONAIL™ Distal Radius System and the legally marketed predicate Radial Nail System have identical indications, utilize the same instrumentation, and are identical in material. Sterilization methods have been updated to reflect the addition of products that are provided sterile.

### 7. Substantial Equivalence- Non-Clinical Evidence

Mechanical testing, including Static Bending Strength, as well as FEA analysis has shown that the performance of the subject screw is statistically equivalent or greater than the predicate screw.

### 8. Substantial Equivalence- Clinical Evidence

N/A

### 9. Substantial Equivalence- Conclusions

The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.