PRECICE UNYTE CoCr System

K162927 · Nuvasive Specialized Orthopedics, Inc. · HSB · Apr 6, 2017 · Orthopedic

Device Facts

• Record ID: K162927
• Device Name: PRECICE UNYTE CoCr System
• Applicant: Nuvasive Specialized Orthopedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Apr 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PRECICE UNYTE CoCr System is indicated for open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.

Device Story

Intramedullary fixation system for tibia; comprises CoCr nail, locking screws, end cap, and external remote controller (ERC). Nail contains rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. Physician implants nail into intramedullary canal, securing with locking screws. Post-operatively, patient or clinician uses ERC to non-invasively adjust nail length via magnetic coupling to internal gearing. Enables controlled limb lengthening or compression for fracture reduction. Benefits include non-invasive adjustment, reducing need for secondary surgical procedures for length modification.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included static/dynamic four-point bend, static torque to failure (ASTM F1264), shelf life/packaging validation, biocompatibility (ISO 10993-1), and pyrogenicity testing.

Technological Characteristics

Intramedullary nail constructed of cobalt chromium (CoCr) alloy. Features telescoping lead screw/nut assembly, planetary gearing, and rare earth magnet. Adjusted non-invasively via external electromagnetic controller. Mechanical testing per ASTM F1264-14. Sterilization via gamma radiation (nail) or moist heat (screws/instruments).

Indications for Use

Indicated for patients requiring open/closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or limb lengthening of the tibia.

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

• PRECICE Trauma Nail System (K160267)

Reference Devices

• PRECICE Intramedullary Limb Lengthening System (K160325)

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

NuVasive Specialized Orthopedics, Inc. Cora Sim Sr. Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656

April 6, 2017

Re: K162927

Trade/Device Name: PRECICE UNYTE CoCr System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 17, 2016 Received: October 19, 2016

Dear Cora Sim:

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 (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.

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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" (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 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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## Indications for Use

510(k) Number (if known) K162927

Device Name PRECICE UNYTE CoCr System

Indications for Use (Describe)

The PRECICE UNYTE CoCr System is indicated for open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.

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

Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)
> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic on the left, followed by the company name in silver lettering. Below the company name, the words "SPECIALIZED ORTHOPEDICS, INC." are written in purple.

## 510(k) Summary PRECICE® UNYTE CoCr System 510(k) Summary - K162927 March 2, 2017

- 1. NuVasive Specialized Orthopedics, Inc. Company: 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
Contact: Cora Sim Sr. Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

Date of Submission: March 2, 2017

- 2. Proprietary Trade Name: PRECICE UNYTE CoCr System
- 3. Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020)
- 4. Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
- ട്. Product Description: The PRECICE UNYTE CoCr System is composed of the PRECICE UNYTE CoCr Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The nail is available in tibia models with various diameters and lengths to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters, lengths, and configurations (fully and partially threaded). The PRECICE CoC's Nail and end cap are supplied sterile by gamma radiation while the locking screws and surgical instruments are supplied non-sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is supplied either pre-distracted by 10 mm to allow for compression fracture reduction techniques or fully retracted for limb lengthening applications.
- Indications: The PRECICE UNYTE CoCr System is indicated for open and closed fracture 6. fixation, pseudoarthrosis, mal-unions and non-unions, or limb lengthening of the tibia.

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Image /page/4/Picture/0 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic to the left of the company name. The company name is written in silver, with the words "SPECIALIZED ORTHOPEDICS, INC." written in purple below the name.

- 7. Substantial equivalence: A detailed comparison to the predicate device demonstrates that the PRECICE UNYTE CoCr System is substantially equivalent to the following 510(k) cleared device:

| Trade Name: | PRECICE® Trauma Nail System |
|--------------------------|-----------------------------|
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K160267 |

In addition, the PRECICE UNYTE CoCr System designates the following 510(k) cleared reference device:

| Trade Name: | PRECICE® Intramedullary Limb Lengthening System |
|--------------------------|-------------------------------------------------|
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K160325 |

Substantial equivalence is based on indications for use, technological characteristics, principles of operation, and on in vitro testing performed.

The PRECICE UNYTE CoCr Nail System subject to this 510(k) and the predicate device have similar indications for use. Specifically, both systems are indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of the tibia. This 510(k) is intended to include additional implant sizes utilizing cobalt chromium alloy (CoCr) material and to expand the indications to include limb lengthening.

The PRECICE UNYTE CoCr System has the same technological characteristics and the same principles of operation as that of the predicate. Both devices are inserted into the intramedullary canal of the tibia and secured with locking screws. Both devices are adjusted non-invasively by the External Remote Controller (ERC).

The PRECICE UNYTE CoCr Nail has similar design features as that of the predicate. Both the PRECICE UNYTE CoCr Nail and the predicate are intramedullary nails with a telescoping portion that can adjust the length of the implant. Both devices are inserted into the intramedullary canal of the tibia and secured with locking screws. Both devices are adjusted non-invasively by the external remote controller (ERC). The overall length of the PRECICE UNYTE CoCr Nail is similar to the overall length of the predicate.

Testing of the PRECICE UNYTE CoCr System included sterilization validation, shelf life testing for packaging and device functionality, biocompatibility testing, and testing to ASTM F1264 for intramedullary rods. Pyrogen testing was also performed on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices.

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Image /page/5/Picture/0 description: The image is the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a purple and gray abstract shape on the left. To the right of the shape is the word "NUVASIVE" in gray, and below that is the text "SPECIALIZED ORTHOPEDICS, INC." in purple.

The following specific tests have been performed in order to establish equivalence to the predicate device:

| Test Description | Applicable Test Standard |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| PRECICE, Static Four Point Bend | ASTM F1264-14 |
| PRECICE, Dynamic Four Point Bend | ASTM F1264-14 |
| PRECICE, Static Torque to Failure | ASTM F1264-14 |
| 25 Month Shelf Life Packaging Validation | I.S. EN ISO 11607-1 |
| Standard Guide for Accelerated Aging of Sterile Medical Device Packages | ASTM F1984-07 |
| Standard Test Method for Seal Strength of Flexible Barrier Materials | ASTM F88/F88M-09 |
| Standard Practice for Performance Testing of Shipping Containers and Systems | ASTM D4169-16 |
| Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing | ASTM D4332-14 |
| Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection | ASTM F 1886/F 1886M-15 |
| Packaging for terminally sterilized medical devices Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods | BS EN 868-5 |
| Sterilization of healthcare products - Radiation - Part 2: Establishing the sterilization dose | IS/EN/ISO 11137-2 |
| Biocompatibility | ISO 10993-1 |
| Sterilization of Health Care Products-Moist heat-Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices | ISO 17665-1 |
| Sterilization of Health Care Products-Moist heat-Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1 | ANSI/AAMI/ISO TIR17665-2:2009 |
| Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers | AAMI TIR12:2010 |
| Comprehensive guide to steam sterilization and sterility assurance in health care facilities | ANSI/AAMI ST79:2010&A4:2013 |
| Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices | AAMI TIR39:2009 |
| Pyrogenicity - LAL (Kinetic Turbidimetric Assay Pyrogen Test) | ANSI/AAMI ST72:2011 - Bacterial Endotoxins - Test Methods, Routine Monitoring, and Alternatives to Batch Testing |

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Image /page/6/Picture/0 description: The image is a logo for "NUVASIVE SPECIALIZED ORTHOPEDICS, INC.". The logo features a stylized purple and gray graphic on the left, resembling an abstract leaf or curved shape. To the right of the graphic is the word "NUVASIVE" in a silver, sans-serif font. Below "NUVASIVE" is the text "SPECIALIZED ORTHOPEDICS, INC." in a smaller, purple font.

There are no changes to the design of the ERC being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE Trauma Nail System for the ERC are applicable.

Conclusions can be drawn from the testing performed that the PRECICE UNYTE CoCr System is substantially equivalent to the predicate device.