Infinity™ OCT System, PASS OCT® Spinal System

K210449 · Medtronic · NKG · Mar 18, 2021 · Orthopedic

Device Facts

• Record ID: K210449
• Device Name: Infinity™ OCT System, PASS OCT® Spinal System
• Applicant: Medtronic
• Product Code: NKG · Orthopedic
• Decision Date: Mar 18, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Infinity™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: - Traumatic spinal fractures and/or traumatic dislocations. - Instability or deformity. - Failed previous fusions (e.g. pseudarthrosis). - Tumors involving the cervical spine. - Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System and PASS OCT Spinal System package insert for a list of the indications of use.

Device Story

Posterior spinal fixation system; includes plates, rods, hooks, and screws; used for craniocervical, cervical, and upper thoracic stabilization. Subject device expands Infinity™ OCT System to include patient-specific UNiD OCT rods. Surgeon implants components to immobilize spinal segments; provides structural support during fusion or palliative stabilization for tumors. Operates via rigid locking of components to rods; configuration tailored to individual patient anatomy. Benefits include spinal stabilization and restoration of column integrity. Used in surgical settings by trained spinal surgeons.

Clinical Evidence

Bench testing only. Static and dynamic compression bending and static and dynamic torsion testing performed per ASTM F1717 to confirm mechanical integrity and substantial equivalence. No clinical data provided.

Technological Characteristics

System components: plates, rods, hooks, screws, multi-axial screws, and connectors. Materials: medical grade titanium alloy (ASTM F136/ISO 5832-3), cobalt chromium (ASTM F1537/ISO 5832-12), and PEEK OPTIMA LT1 (ASTM F2026). Mechanical fixation via rigid locking configurations. Not for pedicle fixation in lower thoracic/lumbar spine. Segmental fixation recommended.

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) requiring immobilization/stabilization as adjunct to fusion or for spinal column integrity in advanced tumor cases. Conditions include traumatic fractures/dislocations, instability/deformity, pseudarthrosis, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain). Not for pedicle fixation in lower thoracic (T4-T12) or lumbar spine.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• Infinity™ OCT System (K163375)
• PASS OCT® Spinal System (K153169)

Reference Devices

• CD Horizon™ Spinal System
• Vertex™ Reconstruction System
• PASS LP® Spinal System

Submission Summary (Full Text)

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March 18, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

Medtronic Sofamor Danek, USA Inc. Shweta Sharma Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

## Re: K210449

Trade/Device Name: Infinity™ OCT System, PASS OCT® Spinal System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: February 11, 2021 Received: February 16, 2021

## Dear Shweta Sharma:

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,

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) K210449

Device Name InfinityTM OCT System

### Indications for Use (Describe)

The Infinity™ OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:

- Traumatic spinal fractures and/or traumatic dislocations.
- Instability or deformity.
- · Failed previous fusions (e.g. pseudarthrosis).
- · Tumors involving the cervical spine.

· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System and PASS OCT Spinal System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Indications for Use

510(k) Number (if known) K210449

Device Name PASS OCT® Spinal System

### Indications for Use (Describe)

The PASS OCT® Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT® Spinal System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the PASS OCT® Spinal System may be linked to the PASS LP® Spinal System using the dual diameter rods or specific connecting components.

The PASS OCT® Patient Specific Rod is to be implanted either with PASS OCT® Spinal System or with Infinity (1) OCT Spinal System.

Warning: mixing PASS OCT® and Infinity OCT Spinal Systems connection components is not allowed for the PASS OCT® Patient Specific Rod implantation, as the operating principle for screw attachment or fixation is unsimilar between the two systems and will cause a misalignment of the rod. Mixing lateral loading screw system and top loading screw system is prohibited.

WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of lower thoracic (T4-T12), or lumbar spine.

CAUTION: to be used by or according to the prescription of a licensed physician.

Implantation should only be performed by a surgeon who is familiar with the device, its intended use, dedicated instruments, and understands all aspects of the surgical procedure.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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

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## 510(k) SUMMARY

### 11th February 2021

| I. | Company: | Medtronic Sofamor Danek, USA Inc. |
|----|----------|-----------------------------------|
| | | 1800 Pyramid Place |
| | | Memphis, TN 38132 |
| | | Telephone Number: [phone] |

- Shweta Sharma Contact: Principal Regulatory Affairs Specialist Telephone number: [phone] Email: [e-mail]

| Proprietary Trade Name: | Infinity™ OCT System<br>PASS OCT® Spinal System |
|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Classification Name/<br>Regulation Numbers/<br>Classification/<br>Classification Product<br>Code/Subsequent<br>Product Codes | Posterior Cervical Screw System<br>21 CFR§ 888.3075<br>Class II<br>NKG<br>KWP |

#### II. Predicate Devices:

Primary Predicate:

InfinityTM OCT System (K163375; S.E. 08/21/2017)

Additional Predicate:

PASS OCT® Spinal System (K153169; S.E. 01/29/2016)

These predicate devices have not been subject to a design-related recall.

#### III. Device Description:

The purpose of this submission is to expand the use of previously cleared Infinity™ OCT System with previously cleared PASS OCT® Patient Specific UNiD OCT Rods.

# Infinity™ OCT System

The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws,

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and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.

The Infinity™ OCT System is fabricated from medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.

## PASS OCT® Spinal System

The PASS OCT® Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connection components, which can be rigidly locked to the rod in a variety of configurations.

The implants are manufactured in titanium alloy Ti-6A1-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, Grade Titanium conforming to ASTM F67 and ISO 5832-2, Cobalt-chromium molybdenum alloy Co-Cr28Mo6 according to ISO 5832-12 and ASTM F1537 and in PEEK OPTIMA LT1 conforming to ASTM F2026 specifications.

The PASS OCT® Patient Specific Rod has been designed and manufactured for one specific patient. The PASS OCT® Patient Specific Rod should be used during surgery for this patient only and should not be reused (single use only).

Refer to the surgical technique for additional information. If the PASS OCT® Patient Specific Rod does not perform as intended, use the standard PASS OCT® rod or Infinity™ OCT rod to complete the surgery.

As any orthopaedic implant, these implants must not be reused. For a complete guide to the system, it is important to refer to the surgical technique.

#### IV. Indications for Use:

## Infinity™ OCT System

The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of

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the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3:

- Traumatic spinal fractures and/or traumatic dislocations. .
- . Instability or deformity.
- . Failed previous fusions (e.g. pseudarthrosis).
- . Tumors involving the cervical spine.

Degenerative disease, including intractable radiculopathy and/or myelopathy, neck . and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT Rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert and VertexTM Reconstruction System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS Crosslink™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

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## PASS OCT® Spinal System

The PASS OCT® Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The PASS OCT® Spinal System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the PASS OCT® Spinal System may be linked to the PASS LP® Spinal System using the dual diameter rods or specific connecting components.

The PASS OCT® Patient Specific Rod is to be implanted either with PASS OCT®Spinal System or with Infinity™ OCT Spinal System.

Warning: mixing PASS OCT® and Infinity OCT Spinal Systems connection components is not allowed for the PASS OCT® Patient Specific Rod implantation, as the operating principle for screw attachment or fixation is unsimilar between the two systems and will cause a misalignment of the rod. Mixing lateral loading screw system and top loading screw system is prohibited.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of lower thoracic (T4-T12), or lumbar spine.

Caution: To be used by or according to the prescription of a licensed physician.

Implantation should only be performed by a surgeon who is familiar with the device, its intended use, dedicated instruments, and understands all aspects of the surgical procedure.

#### Comparison of the Technological Characteristics with the Predicate Device: V.

When using the PASS OCT® System Patient Specific UNiD OCT Rods and the Infinity OCT System together; there is no change to the fundamental scientific technology, indications for use, intended use, materials, and levels of attachment as the predicate Infinity™ OCT System devices and PASS OCT® Spinal System UNiD OCT rods.

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The difference between the primary predicate and subject devices is that rods currently used with the predicate Infinity™ OCT System are cut and bent by the surgeon based on the need of the individual case, while the PASS OCT® System UNiD OCT Rods are directly adapted to a unique patient. However, both the subject and predicate systems are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical, cervical, and/or upper thoracic spine (occiput-T3).

#### Performance Data: VI.

In accordance with the Guidance for Industry and FDA Staff - Spinal System 510(k)'s, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.

Rationales were provided confirming that the use of the PASS OCT® System Patient Specific UNiD OCT Rods did not introduce a new worst case when used with the Infinity™ OCT System. However, confirmatory testing (static and dynamic compression bending and static and dynamic torsion per ASTM F1717) performed met the pre-determined acceptance criteria. Therefore, Medtronic believes that the testing confirmed that the subject devices are substantially equivalent to the predicate devices.

#### VII. Conclusions

Based on the test results and supporting information provided in this premarket notification, Medtronic believes the Infinity™ OCT System devices when used with the PASS OCT® System Patient Specific UNiD OCT Rods are at least as safe as and effective as the legally marketed predicate devices.