TRANSLACE™ Spinal Tethering System

K163181 · Medtronic Sofamor Danek USA, Inc. · OWI · May 16, 2017 · Orthopedic

Device Facts

• Record ID: K163181
• Device Name: TRANSLACE™ Spinal Tethering System
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: OWI · Orthopedic
• Decision Date: May 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis: 3. Spinal degenerative surgery, as an adjunct to spinal fusions. The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

Device Story

TRANSLACE™ Spinal Tethering System comprises temporary implants (connectors, tethers) and reusable instruments for orthopedic spinal surgery. System secures spine to rod constructs without bone screws; serves as alternative to traditional sublaminar wires and hooks. Used in OR by surgeons for spinal trauma, deformity correction, and degenerative fusion. Implants provide temporary stabilization as bone anchors during bony fusion development. System includes transport/sterilization tray. Healthcare providers use system to secure spinal constructs; output is mechanical stabilization of spinal segments. Benefits include reduced need for bone screws and effective immobilization during healing.

Clinical Evidence

Bench testing only. Testing included tether grip static/fatigue (ASTM F1798), static axial grip/rotational grip (ASTM F1798), compression fatigue (ASTM F1717), and static weld testing. Biocompatibility evaluated per ISO 10993-1 (chemical characterization, cytotoxicity, acute systemic toxicity, material-mediated pyrogenicity, implantation). Validation included cadaver and True-Trainer (Sawbone) testing and reprocessing validation. All results met predetermined acceptance criteria.

Technological Characteristics

Materials: Titanium-6Al-4V ELI (ASTM F136), polyester, and stainless steel (ASTM F899, A564, A693, A276). System includes connectors, tethers, tensioners, and instrument trays (stainless steel, aluminum, nylon-coated stainless steel, radel, polypropylene, silicone). Mechanical stabilization via tethering/wiring. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for patients 8 years and older requiring spinal stabilization during bone fusion or fracture repair. Applications include spinal trauma (sublaminar/facet wiring), spinal reconstruction (idiopathic, congenital, neuromuscular, or adult scoliosis; spondylolisthesis), and spinal degenerative surgery as an adjunct to fusion. May be used with other metal implants for securement.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Zimmer Universal Clamp (K110348)
• K2M Nile Alternate Fixation System (K143350)

Reference Devices

• CD Horizon® Spinal System (K101074)
• Vertex Reconstruction System (K152338)
• Medtronic Transportation/Sterilization Cassette System (K152241)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

Medtronic Sofamor Danek USA, Inc. Ms. Claire Evans Senior Regulatory Affairs Specialist 1800 Pyramid Place

May 16, 2017

Re: K163181

Memphis. Tennessee 38132

Trade/Device Name: TRANSLACE™ Spinal Tethering System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: April 18, 2017 Received: April 19, 2017

Dear Ms. Evans:

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 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) K163181

Device Name TRANSLACETM Spinal Tethering System

#### Indications for Use (Describe)

The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;

2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

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

| <div> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(k) SUMMARY

# MEDTRONIC Sofamor Danek TRANSLACE™ Spinal Tethering System

## April 2017

| Submitter: | Medtronic Sofamor Danek, USA Inc. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1800 Pyramid Place |
| | Memphis, Tennessee 38132 |
| | Telephone: [phone] |
| | Fax: [phone] |
| Contact Person | Claire Evans |
| | Senior Regulatory Affairs Specialist<br>Direct Telephone: [phone] |
| Date Prepared | April 18, 2017 |
| Name of Device | TRANSLACE™ Spinal Tethering System |
| Common Name | Connector, Tether, Tensioner |
| Trade Name | TRANSLACE™ Spinal Tethering System |
| Regulatory Class,<br>Regulation Number,<br>Regulation Name, and<br>Device Product Code | Class II 21 CFR 888.3010 Bone Fixation Cerclage OWI |
| Predicate Devices | K110348 Zimmer Universal Clamp (S.E. 8/11/2011) – Primary Predicate<br>K143350 K2M Nile Alternate Fixation System (S.E. 2/25/2015)<br><i>The predicates have not been subject to a design related recall.</i> |
| Reference Devices | K101074 CD Horizon® Spinal System (S.E. 6/22/2010) |
| | K152338 Vertex Reconstruction System (S.E. 10/28/2015) |
| | K152241 Medtronic Transportation/Sterilization Cassette System<br>(S.E.1/20/2016) |
| Description of Device | The TRANSLACE™ Spinal Tethering System consists of<br>temporary implants and a reusable instrument for use in<br>orthopedic spinal surgery. The system is intended to provide<br>temporary stabilization as a bone anchor during the development<br>of solid bony fusion and aid in the repair of bone fractures. This<br>system will allow the spine to be secured to a rod construct<br>without the use of a bone screw. It will act as an alternative to<br>sublaminar wires and hooks. |
| | This system consists of:<br>Connector Tether Tensioner Accessory – system specific tray which may be used to transport and sterilize the subject instruments. The subject TRANSLACE™ Spinal Tethering System devices will be available in similar sizes as the predicate systems. |
| Indications for Use | The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:<br>Spinal trauma surgery, used in sublaminar or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions. The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants. |
| Comparison of<br>Technological<br>Characteristics with the<br>Predicate Devices: | The TRANSLACE™ Spinal Tethering System has the same fundamental technology; polyester, titanium and stainless steel material as the predicate devices. The predicate and subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the spine.<br>K110348 Zimmer Universal Clamp (S.E. 8/11/2011) – Primary Predicate K143350 Nile Alternative Fixation System (S.E. 2/25/2015) |
| | The following performance data were provided in support of |
| | substantial equivalence. |
| | |
| | <b>Biocompatibility</b> |
| | The biocompatibility evaluation for the TRANSLACE™ Spinal |
| | Tethering System devices was conducted in accordance with |
| | FDA's Guidance for Industry and FDA Staff "Use of International |
| | Standard ISO-10993, Biological Evaluation of Medical Devices |
| | Part 1: Evaluation and Testing within a Risk Management |
| | Process" issued June 16, 2016. |
| | The subject implants are temporary implants and will be classified |
| | as permanent, >30 day body contact according to with FDA's |
| | Guidance for Industry and FDA Staff "Use of International |
| | Standard ISO-10993, Biological Evaluation of Medical Devices |
| | Part 1: Evaluation and Testing within a Risk Management |
| | Process" issued June 16, 2016. |
| | |
| | The subject Connector is manufactured from identical materials as |
| Performance Data: | the predicate devices, in accordance with the following ASTM |
| | standard: |
| | |
| | • ASTM F136 – Standard Specification for Wrought |
| | Titanium-6 Aluminum-4 Vanadium ELI (Extra Low |
| | Interstitial) Alloy for Surgical Implant Applications |
| | The subject Tether is manufactured from polyester and titanium. |
| | The following tests have been conducted to ensure |
| | biocompatibility: |
| | • Chemical Characterization |
| | • Cytotoxicity |
| | • Acute Systemic Toxicity |
|…