The SpineWorks™ FixxSure® X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:

i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
iii) Fracture;
Dislocation; iv)
Scoliosis: v)
vi) Kyphosis;
vii) Spinal tumor; and
viii) Previous failed fusion (pseudarthrosis).

The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.*

Device Description

The SpineWorks FixxSure X-Link is a transverse stabilizing device utilized to increase the strength of a pedicle screw instrumentation construct in posterior spinal fusion. The FixxSure implant comes in multiple lengths and has the capability of being manipulated into various planes of anqulation. The FixxSure implant has a proprietary dual locking mechanism allowing maximum cross-Link/rod connection while maintaining ease of insertion/use.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Test	Reported Device Performance
Mechanical Testing
Dynamic compression bending	Both constructs successfully completed 5,000,000 cycles.
(ASTM F1717-14)
Applied load: 175N (7.0Nm)
Frequency: 5Hz
Test duration: 5,000,000 cycles

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Two Excella II pedicle screw constructs with the FixxSure X-Link were tested.
Data Provenance: The document does not specify the country of origin for the data. The testing was non-clinical, implying it was conducted as part of the device development and validation by Innovasis, Inc. or a contracted testing facility. It is retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the "test set" in this context refers to physical device constructs undergoing mechanical testing, not a dataset requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" in this context refers to physical device constructs undergoing mechanical testing, not a dataset requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable. The document describes a mechanical performance (non-clinical) study, not a clinical effectiveness study involving human readers or AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable. The device, FixxSure® X-Link, is a physical medical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective mechanical performance metrics as defined by the ASTM F1717-14 standard. The standard itself provides the criteria for evaluating the device's ability to withstand dynamic compression bending without failure for a specified number of cycles.

8. The Sample Size for the Training Set

This information is not applicable. As a physical implant, there is no "training set" in the context of machine learning or algorithm development. The device's design is based on engineering principles and previous successful designs (predicates).

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above. The device's design and manufacturing rely on validated engineering specifications and quality control, not on a "ground truth" derived from a training dataset.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's name and national scope.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 23, 2016

Innovasis, Inc. Mr. Marshall McCarty Director OA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K162143

Trade/Device Name: FixxSure® X-Link Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: September 16, 2016 Received: September 19, 2016

Dear Mr. McCarty:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Vincent J. Devlin -S

for 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) K162143

Device Name FixxSure® X-Link

Indications for Use (Describe)

i) Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
iii) Fracture;
Dislocation; iv)
Scoliosis: v)
vi) Kyphosis;
vii) Spinal tumor; and
viii) Previous failed fusion (pseudarthrosis).

The SpineWorks™ FixxSure® X-Link can also be used with the Talon® Pedicle Screw System.*

*Talon® is a Registered Trademark of Amendia, Inc.

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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Image /page/3/Picture/0 description: The image shows the logo for Innovasis. The logo is black and consists of the word "INNOVASIS" in all caps. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font.

510(k) Summary Report

FixxSure® X-Link (Updated 15 September 2016)

Company: Innovasis, Inc. 614 E. 3900 South Salt Lake City, UT 84107
Contact: Marshall C. McCarty Phone: (801) 261-2236 mmccarty@innovasis.com

FixxSure® X-Link Trade Name:

Common Name: Pedicle Screw System X-Link

Classification: 21 CFR 888.3070 Pedicle screw spinal system Class II Product Code: MNH, MNI Review Panel: Orthopedic-Posterior Spine Devices Brand (PSDB)
Purpose of Submission: Change in intended use.

Applicable Standards:

Acronym	Standard / Authorities / Bodies
AAMI	American Association of Medical Instrumentation
ASTM	American Society for Testing and Materials
CFR	Code of Federal Regulations
FDA CDRH	Food and Drug Administration Center for Device and Radiological Health
ISO	International Organization for Standardization

Standard Citation	Title
Regulatory Standards and Guidance - Medical Devices
ANSI BS EN ISO13485: 2012	Medical Devices - Quality Management Systems - Requirements forRegulatory Purposes
21 CFR Part 801	U.S. FDA, Code of Federal Regulations, Labeling
21 CFR Part 820	U.S. FDA, Code of Federal Regulations, Quality System Regulation
FDA CDRHGuidance	Guidance for Industry and FDA Staff: Spinal Systems 510(k)s
FDA CDRHGuidance	Guidance for Industry and for FDA Staff: Use of Standards in SubstantialEquivalence Determinations
ASTM F136-13	Standard Specification for Wrought Titanium-6 Aluminum-4 VanadiumELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401)

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Image /page/4/Picture/1 description: The image shows the logo for Innovasis. The logo is black and consists of the word "INNOVASIS" in a bold, sans-serif font. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller, sans-serif font. The logo is simple and modern.

FixxSure® X-Link

Standard Citation	Title
ASTM F983-86(R2009)	Standard Practice for Permanent Marking of Orthopaedic ImplantComponents
ASTM F1582-98(R2011)	Standard Terminology Relating to Spinal Implants
ASTM F1717-15	Standard Test Methods for Spinal Implant Constructs in a VertebrectomyModel
Risk Analysis and Design Control: Standards and Guidance
AAMI ANSI ISO14971:2007/(R)2010	(Corrected 4 October 2007) Medical Devices - Application of RiskManagement to Medical Devices
FDA CDRHGuidance	Design Control Guidance for Medical Device Manufacturers
Biocompatibility Evaluations: Standards and Guidance
ANSI/AAMI/ISO10993-1:2009 & Cor1:2010	Biological Evaluation of Medical Devices
Sterilization Methods: Standards and Guidance
AAMI TIR12:2010	Design, Testing and Labeling Reusable Medical Devices for Re-processing in Health Care Facilities
ANSI/AAMIST79:2010 &A1:2010	Comprehensive Guide to Steam Sterilization and Sterility Assurance inHealth Care Facilities
ISO 17665-1: 2006	Sterilization of Healthcare Products - Moist Heat - Part 1 Requirementsfor the Development, Validation and Routine Control of a SterilizationProcess for Medical Devices

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Image /page/5/Picture/1 description: The image shows the logo for Innovasis. The logo is in black and features the word "INNOVASIS" in all caps. Below the main logo, there is a tagline that reads "INNOVATE / INVOLVE / INVENT" in a smaller font size. The logo has a modern and sleek design.

Primary Predicate: K081331 SpineWorks FixxSure® X-Link This predicate has not been subject to a design-related recall.
Additional Predicates: K140238 Innovasis Excella III-D® Spinal System K032739 SeaSpine Crossbar
Device Description: The SpineWorks FixxSure X-Link is a transverse stabilizing device utilized to increase the strength of a pedicle screw instrumentation construct in posterior spinal fusion. The FixxSure implant comes in multiple lengths and has the capability of being manipulated into various planes of anqulation. The FixxSure implant has a proprietary dual locking mechanism allowing maximum cross-Link/rod connection while maintaining ease of insertion/use.
Performance Data: (Non-clinical)—Testing was performed in accordance with ASTM F1717-14, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." Two Excella II pedicle screw constructs with the FixSure X-Link were tested per F1717 for dynamic compression bending at 175N (7.0Nm) and 5Hz. Both constructs successfully completed 5,000,000 cycles.
Materials: The components in this submission are fabricated from Ti-6AI-4V alloy, conforming to ASTM F136, which is known to have good biocompatibility.
Intended Use: The Innovasis SpineWorks brand FixxSure X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal seqments during the fusion process.

Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

Indications for Use: The SpineWorks FixxSure X-Link is intended to work with the Innovasis® Excella® Spinal System to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:

Severe spondylolisthesis (grades 3 and 4) of the L5-S1 i) vertebra;
ii) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
iii) Fracture:
Dislocation: iv)
Scoliosis; v)
vi) Kyphosis;
Spinal tumor; and vii)
viiii) Previous failed fusion (pseudarthrosis).

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Image /page/6/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo is simple and modern.

The SpineWorks FixxSure X-Link can also be used with the Talon® Pedicle Screw System. *

Basis for Substantial Equivalence:

The SpineWorks FixxSure X-Link was cleared by FDA on July 23, 2008 under K081331. Innovasis acquired this product from SpineWorks, LLC in 2014, and has legal ownership of the brand name (SpineWorks) and the device cleared under K081331.

The Innovasis Excella III-D Spinal Deformity System was cleared by FDA on May 7, 2014 under K140238. This system included the Universal X-Link, which was a design upgrade of the cross link cleared October 7, 2010 under K102248. The primary difference in these two implants is the ability of the Universal X-Link to work with both 6.0 and 5.5mm rods.

The technological characteristics were found to be substantially equivalent in terms of design, sizes, materials (biocompatibility profile and processing), and mechanical strength.

Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the subject device is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
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.
(b)
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.