CD HORIZON Spinal System

K152248 · Medtronic Sofamor Danek USA, Inc. · NKB · Nov 5, 2015 · Orthopedic

Device Facts

• Record ID: K152248
• Device Name: CD HORIZON Spinal System
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: NKB · Orthopedic
• Decision Date: Nov 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/umbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation' attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

Device Story

Spinal fixation system comprising rods, hooks, screws, plates, and connectors; used to immobilize and stabilize spinal segments as adjunct to fusion. Implants tailor-made for individual cases; used in posterior, non-cervical spine; also anterolateral thoracic/lumbar use. Operated by surgeons in clinical/OR settings. Provides rigid fixation to support bone healing; benefits patients by correcting deformities and stabilizing unstable spinal segments. Includes instruments for transport and sterilization.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing included static reduction, cantilever load, and torsional load testing conducted in accordance with ASTM F1717. Biocompatibility evaluated per ISO 10993-1.

Technological Characteristics

Materials: Cobalt-28-Chromium-6-Molybdenum (ASTM F1537), Ti-6Al-4V ELI (ASTM F136), medical grade stainless steel (ASTM F899, A564, A693, A276), and acetal (ASTM F1855). System consists of rods, hooks, screws, plates, and connectors. Mechanical fixation principle. Non-powered, manual surgical instrumentation. Sterilization via standard hospital methods.

Indications for Use

Indicated for skeletally mature and pediatric patients requiring posterior, non-cervical spinal fixation as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and failed previous fusion. Pediatric use limited to posterior pedicle screw fixation for progressive deformities and specified conditions. Contraindicated for degenerative disc disease in pediatric patients.

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 (K143375)
• CD HORIZON® Spinal System (K113174)
• CD HORIZON® Spinal System (K122862)
• CD HORIZON® Spinal System (K132639)
• CD HORIZON® Spinal System (K102807)

Reference Devices

• VERTEX® Reconstruction System

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

Medtronic Sofamor Danek USA, Incorporated Ms. Becky Ronner Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

November 5, 2015

Re: K152248

Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: August 7, 2015 Received: August 10, 2015

Dear Ms. Ronner:

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 and 8091); medical device reporting (reporting of medical device-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

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Page 2 - Ms. Becky Ronner

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" (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 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)

#### K152248

Device Name CD HORIZON® Spinal System

### Indications for Use (Describe)

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/umbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation' attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

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

# MEDTRONIC Sofamor Danek CD HORIZON® Spinal System

# August 2015

| Submitter: | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Becky Ronner<br>Senior Regulatory Affairs Specialist<br>Direct Telephone: [phone] |
| Date Prepared | August 7, 2015 |
| Name of Device | CD HORIZON® Spinal System |
| Common Name | Rods, Extenders, Reducers and Inserters |
| Trade Name | CD HORIZON® Spinal System |
| Regulatory Class,<br>Regulation Number,<br>Regulation Name, and<br>Device Product Code | Class III 21 CFR 888.3050 Spinal Interlaminal Fixation Orthosis; KWP 21 CFR 888. 3060 Spinal Intervertebral Body Fixation Orthosis; KWQ 21 CFR 888.3070 Pedicle Screw System; MNH, MNI, NKB, OSH |
| Predicate Devices | K143375 CD HORIZON® Spinal System (S.E 2/13/2015) – Primary Predicate<br><br>Additional Predicates:<br>K113174 CD HORIZON® Spinal System (S.E 11/21/2011)<br>K122862 CD HORIZON® Spinal System (S.E 10/03/2012)<br>K132639 CD HORIZON® Spinal System (S.E 11/25/2013)<br>K102807 CD HORIZON® Spinal System (S.E 11/17/2010)<br><i>The predicates have not been subject to a design related recall.</i> |
| Description of Devices | The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject devices include: |
| | Rods Extenders Sequential Reducer Inserters Modified Labeling (surgical techniques and disassembly/assembly instructions) Accessories, cases, caddies, trays, and lids which may be used to transport and sterilize the subject implants and instruments. The subject CD HORIZON® Spinal System devices will be available in similar sizes as the predicate systems.<br>The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is 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), tumor, pseudarthrosis, and/or failed previous fusion. |
| | Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. |
| Indications for Use | With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. |
| | When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by |
| | tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. |
| | These devices are to be used with autograft and/or allograft. |
| | Pediatric pedicle screw fixation is limited to a posterior approach. |
| | The CD HORIZON® SPIRE™ Plate is a posterior, single-level, |
| | non-pedicle supplemental fixation device intended for use in the |
| | non-cervical spine (T1-S1) as an adjunct to fusion in skeletally |
| | mature patients. It is intended for plate fixation/attachment to |
| | spinous processes for the purpose of achieving supplemental |
| | fixation in the following conditions: degenerative disc disease (as |
| | previously defined), spondylolisthesis, trauma, and/or tumor. |
| | In order to achieve additional levels of fixation, the CD |
| | HORIZON® Spinal System rods may be connected to the |
| | VERTEX® Reconstruction System with the VERTEX® rod |
| | connector. Refer to the VERTEX® Reconstruction System |
| | Package Insert for a list of the VERTEX® indications of use. |
| | The CD HORIZON® Spinal System has the same fundamental |
| | technology and the same cobalt chrome, titanium and stainless |
| | steel materials as the predicate devices. Additionally, acetal is |
| | commonly used for handles of instruments used in spinal surgery. |
| | The predicate and subject devices are intended to help provide |
| Comparison of<br>Technological<br>Characteristics with the<br>Predicate Devices: | immobilization and stabilization of spinal segments as an adjunct |
| | to fusion of the thoracic lumbar and/or sacral spine. |
| | • K143375 CD HORIZON® Spinal System (S.E 2/13/2015) –<br>Primary Predicate |
| | • K113174 CD HORIZON® Spinal System (S.E 11/21/2011) |
| | • K122862 CD HORIZON® Spinal System (S.E 10/03/2012) |
| | • K132639 CD HORIZON® Spinal System (S.E 11/25/2013) |
| | • K102807 CD HORIZON® Spinal System (S.E 11/17/2010) |
| Performance Data: | The following performance data were provided in support of |
| | substantial equivalence. |
| | |
| | <b>Biocompatibility</b> |
| | The biocompatibility evaluation for the CD HORIZON® Spinal |
| | System devices was conducted in accordance with FDA's Draft |
| | Guidance for Industry and FDA Staff "Use of International |
| | Standard ISO-10993, Biological Evaluation of Medical Devices |
| | Part 1: Evaluation and Testing" issued April, 23, 2013. |
| | |
| The subject CD HORIZON® Spinal System rods are permanent | |
| implants and are classified as permanent , >30 day body contact | |
| according to with FDA's Draft Guidance for Industry and FDA | |
| Staff "Use of International Standard ISO-10993, Biological | |
| Evaluation of Medical Devices Part 1: Evaluation and Testing". | |
| The subject rods are manufactured from identical materials as the | |
| | |
| predicate devices, in accordance with the following ASTM | |
| standards: | |
| | |
| ASTM F1537 - Standard Specification for Wrought<br>● | |
| Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical | |
| Implants | |
| | |
| ASTM F136 - Standard Specification for Wrought<br>● | |
| Titanium-6 Aluminum-4 Vanadium ELI (Extra Low<br>Interstitial) Alloy for Surgical Implant Applications | |
| | |
| The CD HORIZON® Spinal System extender, sequential reducer, | |
| and inserters are external communicating devices and are | |
| | |
| classified as limited, up to 24 hours of body contact according to | |
| with FDA's Draft Guidance for Industry and FDA Staff "Use of |…