← Product Code [NKB](/productcode/NKB) · K262193

# RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (K262193)

_Xenix Medical · NKB · Sep 14, 2026 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K262193

## Device Facts

- **Applicant:** Xenix Medical
- **Product Code:** [NKB](/productcode/NKB.md)
- **Decision Date:** Sep 14, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3070
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Indications for Use

The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: - Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Trauma (i.e. fracture or dislocation) - Spinal Stenosis - Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion Xenix Medical RIVA Posterior Fixation System fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. The RIVA Anchor Sacroiliac Fixation System is intended for sacroiliac joint fusion for: - Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. - To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. - Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. When connected to the Xenix Medical RIVA Posterior Fixation System, the RIVA Anchor Sacroiliac Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: - Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) - Spondylolisthesis - Trauma (i.e. fracture or dislocation) - Spinal Stenosis - Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Anchor Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

## Device Story

System comprises titanium/cobalt-chrome spinal implants (pedicle screws, rods, connectors) and navigation instruments; used in thoracic, lumbar, and sacral spine surgery. Implants feature NanoACTIV micro/nano-roughened surface (1-100 nm) to promote osteogenic differentiation of mesenchymal stem cells. Navigation instruments integrate with Medtronic StealthStation S8 for image-guided placement (CT/MRI/fluoroscopy). Surgeon operates system in OR to stabilize spine or sacroiliac joint; implants facilitate biological fusion. Fenestrated screws allow delivery of saline or radiopaque dye. System provides structural support during healing; NanoACTIV surface enhances bone-implant fixation.

## Clinical Evidence

No clinical data. Evidence consists of in vitro evaluations and imaging studies demonstrating that the NanoACTIV surface (1-100 nm) supports mesenchymal stem cell differentiation and mineralized matrix production compared to non-treated surfaces. Mechanical testing per ASTM standards (F1717, F1798, F2193, F543) confirms structural equivalence.

## Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136), Co-28Cr-6Mo (ASTM F1537), Co-35Ni-20Cr-10Mo (ASTM F562). Surface: NanoACTIV micro/nano-roughened (1-100 nm). Principle: Polyaxial pedicle screw/rod construct; image-guided navigation. Sterilization: Gamma irradiation. Connectivity: Compatible with Medtronic StealthStation S8.

## Regulatory 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

- RIVA Posterior Fixation System ([K251154](/device/K251154.md))
- SI-BONE iFuse Bedrock Granite Implant System ([K220195](/device/K220195.md))

## Reference Devices

- neoWAVE LS Lumbar Straight, neoWAVE C Cervical, and Ti3D Cervical ([K222988](/device/K222988.md))
- SOLACE Sacroiliac Fixation System ([K233241](/device/K233241.md))

## Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

September 14, 2026

Xenix Medical
Tyler Holschlag
Vice President Product Development
149 W. Michigan
Orlando, Florida 32806

Re: K262193

Trade/Device Name: RIVA Posterior Fixation System; RIVA Anchor Sacroiliac Fixation System
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral pedicle screw system
Regulatory Class: Class II
Product Code: NKB, KWQ, OLO, OUR
Dated: June 29, 2026
Received: June 29, 2026

Dear Tyler Holschlag:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K262193 - Tyler Holschlag

Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K262193 - Tyler Holschlag

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Sincerely,

# COLIN
O'NEILL -S FDA

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

510(k) Number (if known)

K262193

Device Name

RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology

Indications for Use (Describe)

RIVA Posterior Fixation System with NanoActive Surface Technology

INDICATIONS:

The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:

- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fracture or dislocation)
- Spinal Stenosis
- Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion

Xenix Medical RIVA Posterior Fixation System fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

RIVA Anchor Sacroiliac Fixation System with NanoActive Surface Technology

INDICATIONS:

The RIVA Anchor Sacroiliac Fixation System is intended for sacroiliac joint fusion for:

- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to the Xenix Medical RIVA Posterior Fixation System, the RIVA Anchor Sacroiliac Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:

- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fracture or dislocation)
- Spinal Stenosis
- Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor

FORM FDA 3881 (8/23)

Page 1 of 2

PSC Publishing Services (301) 445-6740

EF

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Pseudoarthrosis
- Failed previous fusion

Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye.

Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Anchor Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic®

StealthStation® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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"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."

FORM FDA 3881 (8/23)

Page 2 of 2

PSC Publishing Services (301) 443-6740

EF

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## 510(k) Summary

|  **Device Trade Name:** | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology  |
| --- | --- |
|  **Manufacturer:** | Xenix Medical 149 W Michigan St. Orlando, FL 32806  |
|  **Contact:** | Tyler Holschlag Vice President of Product Development Xenix Medical  |
|  **Date Prepared:** | September 11, 2026  |
|  **Classifications:** | 21 CFR §888.3070; Thoracolumbosacral pedicle screw system 21 CFR §888.3060; Spinal intervertebral body fixation orthosis 21 CFR §888.3040; Smooth or threaded metallic bone fastener 21 CFR §882.4560; Stereotaxic Instruments  |
|  **Class:** | II  |

Product Codes:

|  ***RIVA Posterior Fixation System*** | NKB, KWQ, OLO  |
| --- | --- |
|  ***RIVA Anchor Sacroiliac Fixation System*** | OUR, NKB, OLO  |

***RIVA Posterior Fixation System with NanoACTIV Surface Technology***

**INDICATIONS:**

The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:

- Degenerative disc disease (defined as discogenic back pain with

K262193 1 of 6

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degeneration of the disc confirmed by history and radiographic studies)

- Spondylolisthesis
- Trauma (i.e. fracture or dislocation)
- Spinal Stenosis
- Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion

Xenix Medical RIVA Posterior Fixation System fenestrated screws are intended to be used with saline or radiopaque dye.

Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

### RIVA Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology
INDICATIONS:

The RIVA Anchor Sacroiliac Fixation System is intended for sacroiliac joint fusion for:

- Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to the Xenix Medical RIVA Posterior Fixation System, the RIVA Anchor Sacroiliac Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation

K262193 2 of 6

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system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:

- Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fracture or dislocation)
- Spinal Stenosis
- Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion

Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Anchor Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

### RIVA Posterior Fixation System with NanoACTIV Surface Technology

### DEVICE DESCRIPTION:

The Xenix Medical RIVA Posterior Fixation System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Xenix Medical RIVA Posterior Fixation System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of polyaxial pedicle screws, as well as connecting spinal rods, connectors, crossbars, and a separate set screw locking element. The instruments included in the Xenix Medical RIVA Posterior Fixation System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and

K262193 3 of 6

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caddies for storage, protection, and organization prior to and during the steam sterilization process.

Devices incorporate Xenix Medical's proprietary NanoACTIV™ micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10⁻⁹) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

### RIVA Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology

DEVICE DESCRIPTION:

The Xenix Medical RIVA Anchor Sacroiliac Fixation System consists of Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-136) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.

Devices incorporate Xenix Medical's proprietary NanoACTIV™ micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10⁻⁹) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.

Predicate Devices:

|  Device Name(s) | Manufacturer | K-Number  |
| --- | --- | --- |
|  *Primary Predicate*  |   |   |
|  RIVA Posterior Fixation System | Xenix Medical | K251154  |
|  *Reference Predicate Devices*  |   |   |
|  neoWAVE LS Lumbar Straight, neoWAVE C Cervical, and Ti3D Cervical | Xenix Medical | K222988  |
|  SOLACE Sacroiliac Fixation System | Xenix Medical | K233241  |
|  SI-Bone Bedrock Granite | SI-Bone | K220195  |

### Performance Testing Summary:

Engineering analysis and rationale was provided to demonstrate that the subject RIVA Fixation System NanoACTIV screws are substantially equivalent to the predicate RIVA Posterior Fixation System.

K262193 4 of 6

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Engineering analysis and rationale was provided to demonstrate that the subject RIVA Anchor Sacroiliac Fixation System NanoACTIV Screws are substantially equivalent to the predicates RIVA Posterior Fixation System and SOLACE Sacroiliac Fixation System.

In vitro evaluations, imaging studies, and testing were performed to confirm that the deliberately modified NanoACTIV surface produces micro- and nano-scale surface roughness ranging in size between 1-100 nanometers, which exhibit specific osteogenic differentiation. The in vitro study results demonstrated that the modified NanoACTIV nano surface supports differentiation of mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix as compared to non-treated micro-rough AM titanium surfaces. These evaluations further demonstrated that the endogenous cellular and biochemical response elicited by the NanoACTIV surface on non-additively manufactured titanium was shown to be equivalent to that of the NanoACTIV surface on additively manufactured implants.

## Summary of Substantial Equivalence:

The Xenix Medical RIVA Posterior Fixation System with NanoACTIV Surface Technology is substantially equivalent to its primary predicate, the Xenix Medical RIVA Posterior Fixation System (K251154), with respect to intended use, indications for use, principle of operation, and design: both devices incorporate the same polyaxial pedicle screw, connecting rod, connector, crossbar, and set-screw construct, the same titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome alloy (per ASTM F1537/F562) implant materials, the same subtractive manufacturing process, and the same implant size ranges (Ø4.5–12.5mm, 25–110mm). The principal technological differences are, first, an additional manufacturing step that imparts the proprietary NanoACTIV micro- and nano-roughened surface to the implant, a surface modification with the same nanoscale characteristics (1–100 nm) previously cleared under K233241 and K222988, and second, a change in implant sterility: the predicate device implants are supplied non-sterile for terminal moist-heat sterilization at the healthcare facility, while the subject device implants are supplied sterile via gamma irradiation, consistent with the implants cleared under K233241 and K222988. In vitro osteogenic differentiation and imaging studies characterizing the NanoACTIV surface, together with mechanical testing per ASTM F1717 and ASTM F1798, demonstrate that these differences do not raise new or different questions of safety or effectiveness.

The RIVA Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology is substantially equivalent to its primary predicate, the SI-BONE iFuse Bedrock Granite Implant System (K220195), and to the reference predicates SOLACE Sacroiliac Fixation

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System (K233241) and RIVA Posterior Fixation System (K251154), with respect to intended use, indications for use, and principle of operation. Like the predicate and reference devices, the RIVA Anchor implant is a fully threaded, fenestrated, cannulated titanium alloy (Ti-6Al-4V ELI) screw with a self-tapping tip, intended for guidewire-assisted, image-guided placement across the sacroiliac joint, and it connects to the same RIVA modular head used in the RIVA Posterior construct. The device is supplied sterile via gamma irradiation, consistent with the predicate and reference devices, and incorporates the same NanoACTIV surface process as the SOLACE and neoWAVE/Ti3D devices. Differences in implant diameter and length ranges relative to the predicate and reference devices do not alter the fundamental design or principle of operation. Mechanical testing per ASTM F1717, F1798, F2193, and F543, together with engineering rationale, demonstrate that these differences do not raise new or different questions of safety or effectiveness. Accordingly, the RIVA Posterior Fixation System and RIVA Anchor Sacroiliac Fixation System, each with NanoACTIV Surface Technology, are substantially equivalent to the cited predicate devices.

## Conclusion:

The Xenix Medical RIVA Posterior Fixation System with NanoACTIV Surface Technology and RIVA Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology are substantially equivalent to the cited predicate devices with respect to intended use, indications for use, design, function, materials, and performance. The differences in the technological characteristics between the subject device and the predicate devices do not raise new or different questions of safety and effectiveness.

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**Source:** [https://fda.innolitics.com/device/K262193](https://fda.innolitics.com/device/K262193)

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**Cite:** Innolitics at https://innolitics.com