CD HORIZON™ Fenestrated Screw Set

K170347 · Medtronic Sofamor Danek USA · NKB · Apr 4, 2017 · Orthopedic

Device Facts

• Record ID: K170347
• Device Name: CD HORIZON™ Fenestrated Screw Set
• Applicant: Medtronic Sofamor Danek USA
• Product Code: NKB · Orthopedic
• Decision Date: Apr 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used without cement, the CD HORIZON Fenestrated Screws (with or without SEXTANT® or LONGITUDE® instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion. When used in conjunction with KYPHON HV-R™ Fenestrated Screw Bone Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV-R™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Story

Cannulated multi-axial pedicle screws with distal fenestrations; used in thoracic/lumbar spine. Operates as traditional pedicle screw for spinal fixation; alternatively, fenestrations allow controlled delivery of PMMA bone cement into vertebral body for structural reinforcement in tumor patients. Used in surgical settings by orthopedic or neurosurgeons. Connects to 4.75mm, 5.5mm, and 6.0mm rods. Provides mechanical stabilization of spinal column; cement augmentation restores integrity in compromised bone. Non-sterile delivery.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical mechanical testing previously provided in K152604, demonstrating equivalence to traditional pedicle screws in the CD HORIZON Spinal System.

Technological Characteristics

Cannulated multi-axial screws; diameters 4.5mm-10.5mm; lengths 30-100mm. Features six distal fenestrations for PMMA cement delivery. Compatible with 4.75mm, 5.5mm, and 6.0mm rods. Non-sterile.

Indications for Use

Indicated for patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), pseudarthrosis, or failed fusion requiring posterior non-cervical fixation. Also indicated for patients with advanced stage thoracic/lumbar tumors with limited life expectancy when used with bone cement.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• CD HORIZON™ Spinal System (K113174)
• CD HORIZON™ Fenestrated Screw Set (K152604)

Submission Summary (Full Text)

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three 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

Medtronic Sofamor Danek USA Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pvramid Place Memphis. Tennessee 38132

Re: K170347

Trade/Device Name: CD HORIZON™ Fenestrated Screw Set Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 31, 2017 Received: February 3, 2017

Dear Mr. Grant:

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

{1}------------------------------------------------

related 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 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K170347

#### Device Name

CD HORIZON Fenestrated Screw Set

#### Indications for Use (Describe)

When used without cement, the CD HORIZON Fenestrated Screws (with or without SEXTANT® or LONGITUDE® instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.

When used in conjunction with KYPHON HV-R™ Fenestrated Screw Bone Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV-R™ Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary Medtronic Sofamor Danek USA CD HORIZON™ Fenestrated Screw Set

| | March 2017 |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Medtronic Sofamor Danek USA<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
| Contact(s) | Lee Grant<br>Distinguished Regulatory Affairs Advisor<br>Direct Telephone - 901-344-0807 |
| Date Prepared | March 30, 2017 |
| Common Name | CD HORIZON™ Fenestrated Screw Set<br>CD HORIZON™ Fenestrated Screw Set |
| Regulatory Class | Class II, NKB |
| Regulation Number | 21 CFR 888.3070 Thoracolumbosacral Pedicle Screw System |
| Regulation Name and Device<br>Product Classification Code | |
| Predicate Devices | K113174 - CD HORIZON™ Spinal System (SE 11/21/11)<br>Secondary Predicate<br>K152604 – CD HORIZON™ Fenestrated Screw Set (SE 01/06/16)<br>The predicate devices have not been subject to a design related recall |
| Description of Device | The CD HORIZON™ Fenestrated Screw Set consists of a variety of cannulated<br>multi-axial screws (MAS) with fenestrations offered in diameters ranging from<br>4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD<br>HORIZON™ LEGACY™ and CD HORIZON™ SOLERA™ implants<br>contained in the CD HORIZON™ Spinal System. The CD HORIZON™<br>Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and<br>6.0mm diameter rods and associated connecting components contained within<br>the CD HORIZON™ Spinal System. The screws contain six fenestrations near<br>the distal tip of the screw which provides a controlled means to deliver a small<br>amount of polymethylmethacrylate (PMMA) bone cement into a targeted<br>vertebral body. These implants may also serve as traditional pedicle screws when<br>used without bone cement. These screws are provided non-sterile. |
| Submission Purpose | The subject CD HORIZON™ Fenestrated Screws are being introduced into the<br>market for use without cement, for standard CD HORIZON® Spinal System<br>indications. |
| Indications for Use: | When used without cement, the CD HORIZON Fenestrated Screws (with or<br>without SEXTANT® or LONGITUDE® instrumentation) are intended for<br>posterior, non-cervical fixation as an adjunct to fusion for the following<br>indications: degenerative disc disease (defined as back pain of discogenic origin<br>with degeneration of the disc confirmed by history and radiographic studies),<br>spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis,<br>curvatures (i.e., scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed<br>previous fusion.<br><br>When used in conjunction with KYPHON HV-R™ Fenestrated Screw Bone<br>Cement, the CD HORIZON™ Fenestrated Screws are intended to restore the<br>integrity of the spinal column even in the absence of fusion for a limited time |
| period in patients with advanced stage tumors involving the thoracic and lumbar | |
| spine in whom life expectancy is of insufficient duration to permit achievement | |
| of fusion. CD HORIZON™ Fenestrated Screws augmented with KYPHON HV- | |
| RTM Fenestrated Screw Cement are for use at spinal levels where the structural | |
| integrity of the spine is not severely compromised. | |
| Comparison of Technological<br>Characteristics with the<br>Predicate Devices | The screws which comprise the CD HORIZON™ Fenestrated Screw Set are<br>identical to those cleared in the previous CD HORIZON™ Fenestrated Screw<br>Set in K152604 for the same indications when used in conjunction with cement<br>augmentation. These screws were declared substantially equivalent to non-<br>augmented CD HORIZON Spinal System screws cleared in K113164 for which<br>the same non-cement augmented indications stated in the Indications for Use<br>section. No modifications have been made to the subject screws. They are<br>identical to the predicate screws with respect to indications, design, size,<br>intended use, cannulation, fundamental scientific technology, and materials. |
| Performance Data | Non-Clinical mechanical testing of the subject fenestrated screws demonstrating<br>substantial equivalence to the traditional pedicle screws found in the predicate<br>CD HORIZON® Spinal System was previously provided in K152604. |
| Conclusion | Based on the information provided herein, the subject CD HORIZON®<br>Fenestrated Screws are substantially equivalent to the predicate CD HORIZON®<br>Spinal System screws cleared in K113174 |

{4}------------------------------------------------