Cortera Spinal Fixation System

K221403 · Surgalign Spine Technologies · NKB · Aug 19, 2022 · Orthopedic

Device Facts

• Record ID: K221403
• Device Name: Cortera Spinal Fixation System
• Applicant: Surgalign Spine Technologies
• Product Code: NKB · Orthopedic
• Decision Date: Aug 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Cortera" Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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); spondy lolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera" Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera" Spinal Fixation 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. Pediatric pedicle screw fixation is limited to a posterior approach. The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.

Device Story

Thoracolumbosacral pedicle screw system providing spinal segment immobilization and stabilization; adjunct to fusion. Components include screws, rods, and locking set screws; used with manual surgical instruments for open or minimally invasive approaches. Implants available in various sizes to match patient anatomy. Used by surgeons in clinical settings. System provides mechanical stabilization to the spine; intended to facilitate fusion when used with autograft/allograft. Benefits include correction of deformities and stabilization of spinal segments in patients with degenerative, traumatic, or congenital conditions.

Clinical Evidence

Bench testing only. Testing included static and dynamic compression (ASTM F1717), static torsion (ASTM F1717), and axial pulloff (ASTM F1798). No clinical data provided.

Technological Characteristics

Thoracolumbosacral pedicle screw system. Materials: Titanium alloy (Ti6Al4V, ASTM F136) for screws/set screws; Titanium alloy or Cobalt chromium alloy (Co-28Cr-6Mo, ASTM F1537) for rods. Non-sterile. Manual instrumentation. Mechanical fixation principle.

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 approach for progressive deformities (idiopathic, neuromuscular, congenital scoliosis) and specified conditions.

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

• Invictus Spinal Fixation System (K192938)

Reference Devices

• Streamline TL Spinal Fixation System (K192800)

Submission Summary (Full Text)

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August 19, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Surgalign Spine Technologies Jessica Jho Director, Regulatory Affairs 520 Lake Cook Road Suite 315 Deerfield, Illinois 60015

Re: K221403

Trade/Device Name: Cortera Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: August 12, 2022 Received: August 15, 2022

Dear Jessica Jho:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221403

Device Name Cortera™ Spinal Fixation System

### Indications for Use (Describe)

The Cortera" Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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); spondy lolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera" Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera" Spinal Fixation 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. Pediatric pedicle screw fixation is limited to a posterior approach.

The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.

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

| <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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Image /page/3/Picture/0 description: The image shows the Surgalign logo. The logo features a stylized spine on the left side, with the word "Surgalign" in blue letters to the right. The spine is depicted in two colors, with the upper portion in gray and the lower portion in blue. The logo is clean and modern, with a focus on the company's name and its connection to spinal health.

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

| SUBMITTER: | Surgalign Spine Technologies<br>520 Lake Cook Rd, Suite 315<br>Deerfield, IL 60015 USA |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jessica Jho<br>Director of Regulatory Affairs<br>Surgalign Spine Technologies<br>[e-mail]<br>[phone] |

Date Summary Prepared: August 19, 2022

#### II. DEVICE

| Trade or Proprietary Name: | Cortera™ Spinal Fixation System |
|----------------------------|----------------------------------------------|
| Common Name: | Thoracolumbosacral pedicle screw system |
| Regulation Number: | 21 CFR §888.3070 |
| Classification: | Class II |
| Product Code: | NKB, Thoracolumbosacral pedicle screw system |

#### III. LEGALLY MARKETED PREDICATE DEVICES

| Predicate Device | | | | |
|------------------|--------------------------------------|-------------------|--|--|
| 510(k) | Product Name | Clearance Date | | |
| K192938 | Invictus Spinal Fixation System | December 12, 2019 | | |
| Reference Device | | | | |
| 510(k) | Product Name | Clearance Date | | |
| K192800 | Streamline TL Spinal Fixation System | January 14, 2020 | | |

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Image /page/4/Picture/0 description: The image shows the Surgalign logo. The logo features a stylized spine on the left side, with the word "Surgalign" in blue letters to the right of the spine. The spine is curved and has a gradient of gray and blue. The logo is simple and modern.

#### IV. DEVICE DESCRIPTION

The Cortera™ Spinal Fixation System is a Thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or the sacral spine. The System consists of screws, rods, locking set screws and associated manual surgical instruments for an open or minimally invasive surgical approach. The screws and set screws are manufacturered from titanium alloy (Ti6Al4V per ASTM F136). The rods are available in titanium alloy or cobalt chromium alloy (Co-28Cr-6Mo per ASTM F1537). The implants are available in a variety of sizes to accommodate individual patient anatomy and are provided non-sterile.

The Cortera™ Spinal Fixation System rods may be used in connection with Streamline Cross Connectors, covered in K192800. The Streamline Cross Connectors accept various rod diameters and are appropriate for use with Cortera™ Spinal Fixation System 5.5 mm diameter rod-based systems. These cross connectors will keep their original cleared trade name.

#### V. INDICATIONS FOR USE

The Cortera™ Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Cortera™ Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Cortera™ Spinal Fixation 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. Pediatric pedicle screw fixation is limited to a posterior approach.

The Cortera™ Spinal Fixation System is intended to be used with an autograft and/or allograft.

#### VI. TECHNICAL COMPARISON TO PREDICATE

The technological design features of the subject devices, such as intended use, indications for use, design, function and technology, were compared to the predicates and it was demonstrated that they are substantially equivalent.

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Image /page/5/Picture/0 description: The image shows the logo for "Surgalign". The logo features a stylized "S" shape in blue and gray, with small white shapes resembling vertebrae within the blue portion. The word "urgalign" is written in a blue, sans-serif font to the right of the "S" shape, with a trademark symbol in the upper right corner.

#### VII. PERFORMANCE DATA

Nonclinical testing performed on the Cortera™ Spinal Fixation System supports substantial equivalence to other predicate devices. The following testing was performed:

- l Static and dynamic compression testing per ASTM F1717
- . Static torsion testing per ASTM F1717
- Axial Pulloff (Fx) testing per ASTM F1798

The results demonstrate that the subject Cortera™ Spinal Fixation System is substantially equivalent to other predicate devices.

## VIII. CONCLUSION

Based on the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to the legally marketed devices in regards to indication for use, intended use, design, technology, and performance.

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