Cortera Spinal Fixation System by Xtant Medical Holdings, Inc.

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, or lordosis) 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 Description

The Cortera Spinal Fixation System (Cortera 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 Cortera System consists of screws, rod-to-rod connectors, lateral offset connectors, rods, locking set screws and associated reusable manual surgical instruments for an open or minimally invasive surgical approach. The screws, rod-to-rod connectors, lateral offset connectors, and set screws are manufactured 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. A variety of these implant configurations were previously covered in K221403.

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Cortera™ Spinal Fixation System, based on the provided FDA 510(k) summary:

This device is a spinal fixation system, which is a physical implant, not an AI/software device. Therefore, many of the requested criteria (like ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training/test set sample sizes for AI) are not applicable. The documentation focuses on engineering and material performance rather than diagnostic accuracy or human interpretation.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cortera™ Spinal Fixation System are implicitly derived from adherence to established FDA guidance documents and international standards for medical devices, particularly those for spinal fixation systems, biocompatibility, and reprocessing. The "reported device performance" is the conclusion that the device "complies with its predetermined specifications and the applicable guidance document" based on the verification and validation (V&V) activities.

Acceptance Criteria Category	Specific Criteria (Implicit via adherence to standards)	Reported Device Performance and Study Conclusion
Reprocessing	- Compliance with FDA Guidance Document: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2024). - Compliance with AAMI/ANSI ST79: 2017, Am1: 2020, Am2: 2020, Am3: 2020, Am4: 2020 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities). - Compliance with ISO 17665-1: 2006 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices). - Achievement of a sterility assurance level (SAL) of 10-6 for validated steam sterilization parameters (Pre-vacuum, 132°C (270°F), 4 minutes exposure, 30 minutes dry time).	"Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document." Specifically, the device achieved an SAL of 10-6 with a recommended dry time of 30 minutes (a change from the predicate's 40 minutes, which was apparently validated as acceptable).
Biocompatibility	- Compliance with FDA Guidance Document: "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'" (September 8, 2023). - Compliance with ISO 10993-1: 2018 (Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process).	"Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document."
Bench Performance Testing	- Compliance with FDA Guidance Document: "Spinal System 510(k)s" (May 3, 2004). - Adherence to materials standards: ASTM F136-13, ASTM F899-20, ASTM F1537-20, ASTM F2063-18. - Adherence to mechanical testing standards: ASTM F1717-21 (Spinal Implant Constructs in a Vertebrectomy Model), ASTM F1798-21 (Evaluating Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants).	"Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document." "Verification and validation activities were conducted to establish the performance and safety characteristics of the Cortera System. The results of these activities demonstrate that the Cortera System is substantially equivalent to the predicate device when used in accordance with its intended use and labeling." This implies the mechanical properties and material composition meet the relevant ASTM standards for spinal implants.

Study Details (Not applicable for this type of device submission)

Given that this is a 510(k) submission for a physical medical device (spinal fixation system), rather than a diagnostic AI/software device, many of the requested details about studies, experts, and ground truth are not relevant in the context of this document. The submission relies on bench testing and adherence to consensus standards and guidance documents to demonstrate substantial equivalence to a predicate device.

Sample size used for the test set and the data provenance: This refers to the number of physical components (screws, rods, connectors) tested in bench studies. The document does not specify exact numbers but indicates that various configurations and sizes were included. Data provenance is implied to be from laboratory bench testing conducted by the manufacturer, Xtant Medical Holdings, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by objective engineering measurements against defined specifications and recognized industry standards (e.g., ASTM standards for material strength and fatigue).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance is measured objectively according to engineering test protocols.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and performance is based on objective engineering and materials science standards (e.g., mechanical strength, fatigue life, biocompatibility, and reprocessing efficacy) measured through laboratory bench testing.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Summary

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August 2, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.

Xtant Medical Holdings, Inc. Rebecca Lennemann VP, Quality and Regulatory Affairs 664 Cruiser Lane Belgrade, Montana 59714

Re: K241892

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: June 28, 2024 Received: June 28, 2024

Dear Rebecca Lennemann:

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" (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).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-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 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.

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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Eileen
Digitally signed by
Eileen Cadel -S
Date: 2024.08.02
Cadel -S 11:48:29 -04'00'

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

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Indications for Use

Submission Number (if known)

K241892

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); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); 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.

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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K241892 Page 1 of 1

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SubmissionDate:	28 June 2024
Submitter:	Xtant Medical Holdings, Inc.664 Cruiser LaneBelgrade, MT 59714
Submitter andOfficialContact:	Ms. Rebecca LennemannDirector, RA/QAXtant Medical Holdings, Inc.664 Cruiser LaneBelgrade, MT 59714+1 (406) 924-5878rlennemann@xtantmedical.com
ManufacturingSite:	Xtant Medical Holdings, Inc.664 Cruiser LaneBelgrade, MT 59714
Trade Name:	Cortera™ Spinal Fixation System
ClassificationName:	Thoracolumbosacral pedicle screw system
ClassificationRegulation /Product Code	21 CFR §888.3070 / NKB
SubstantiallyEquivalentDevices:	Proposed XtantMedical Model	Predicate 510(k)Number	Predicate Manufacturer / Model
	Cortera™ SpinalFixation System	K221403	Surgalign Spine Technologies /Cortera Spinal Fixation System(Primary Predicate)
		K192800	Pioneer Surgical Technology, Inc.(DBA RTI Surgical, Inc.) /Streamline TL Spinal FixationSystem (Additional Predicate)

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DeviceDescription:	The Cortera Spinal Fixation System (Cortera System) is athoracolumbosacral pedicle screw system intended to provideimmobilization and stabilization of spinal segments as an adjunct to fusionof the thoracic, lumbar and/or the sacral spine. The Cortera System consistsof screws, rod-to-rod connectors, lateral offset connectors, rods, locking setscrews and associated reusable manual surgical instruments for an open orminimally invasive surgical approach. The screws, rod-to-rod connectors,lateral offset connectors, and set screws are manufactured from titaniumalloy (Ti6Al4V per ASTM F136). The rods are available in titanium alloy orcobalt chromium alloy (Co-28Cr-6Mo per ASTM F1537). The implants areavailable in a variety of sizes to accommodate individual patient anatomyand are provided non-sterile. A variety of these implant configurations werepreviously covered in K221403.The Cortera System rods may be used in connection with Streamline CrossConnectors, cleared by FDA in K192800. The Streamline Cross Connectorsaccept various rod diameters and are appropriate for use with CorteraSystem 5.5 mm diameter rod-based systems. These cross connectors willkeep their original cleared trade name.
Indicationsfor Use:	The CorteraTM Spinal Fixation System is intended for posterior, non-cervicalfixation in skeletally mature patients as an adjunct to fusion for thefollowing indications: degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic 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 pediatricpatients, the CorteraTM Spinal Fixation System implants are indicated as anadjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,kyphosis, or lordosis) including idiopathic scoliosis, neuromuscularscoliosis, and congenital scoliosis. Additionally, the CorteraTM SpinalFixation System is intended to treat pediatric patients diagnosed with thefollowing conditions: spondylolisthesis/spondylolysis, fracture caused bytumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatricpedicle screw fixation is limited to a posterior approach.The CorteraTM Spinal Fixation System is intended to be used with anautograft and/or allograft.

DeviceDescription:

The Cortera Spinal Fixation System (Cortera System) is athoracolumbosacral pedicle screw system intended to provideimmobilization and stabilization of spinal segments as an adjunct to fusionof the thoracic, lumbar and/or the sacral spine. The Cortera System consistsof screws, rod-to-rod connectors, lateral offset connectors, rods, locking setscrews and associated reusable manual surgical instruments for an open orminimally invasive surgical approach. The screws, rod-to-rod connectors,lateral offset connectors, and set screws are manufactured from titaniumalloy (Ti6Al4V per ASTM F136). The rods are available in titanium alloy orcobalt chromium alloy (Co-28Cr-6Mo per ASTM F1537). The implants areavailable in a variety of sizes to accommodate individual patient anatomyand are provided non-sterile. A variety of these implant configurations werepreviously covered in K221403.The Cortera System rods may be used in connection with Streamline CrossConnectors, cleared by FDA in K192800. The Streamline Cross Connectorsaccept various rod diameters and are appropriate for use with CorteraSystem 5.5 mm diameter rod-based systems. These cross connectors willkeep their original cleared trade name.

Indicationsfor Use:

The CorteraTM Spinal Fixation System is intended for posterior, non-cervicalfixation in skeletally mature patients as an adjunct to fusion for thefollowing indications: degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic 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 pediatricpatients, the CorteraTM Spinal Fixation System implants are indicated as anadjunct to fusion to treat progressive spinal deformities (i.e. scoliosis,kyphosis, or lordosis) including idiopathic scoliosis, neuromuscularscoliosis, and congenital scoliosis. Additionally, the CorteraTM SpinalFixation System is intended to treat pediatric patients diagnosed with thefollowing conditions: spondylolisthesis/spondylolysis, fracture caused bytumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatricpedicle screw fixation is limited to a posterior approach.The CorteraTM Spinal Fixation System is intended to be used with anautograft and/or allograft.

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Characteristic	Surgalign Spine TechnologiesCortera Spinal Fixation System(K221403)	Xtant MedicalHoldings, Inc.Cortera™ Spinal FixationSystem(Proposed Device)	Discussion ofDifferences
Indicationsfor Use	The Cortera™ Spinal FixationSystem is intended for posterior,non-cervical fixation in skeletallymature patients as an adjunct tofusion for the followingindications: degenerative discdisease ( defined as back pain ofdiscogenic origin withdegeneration of the disc confirmedby history and radiographicstudies); spondylolisthesis; trauma(i.e. fracture or dislocation); spinalstenosis; curvatures (i.e., scoliosis,kyphosis and/or lordosis); tumor;pseudarthrosis; and/or failedprevious fusion.When used for posterior non-cervical pedicle screw fixation inpediatric patients, the Cortera™Spinal Fixation System implantsare indicated as an adjunct tofusion to treat progressive spinaldeformities (i.e. scoliosis,kyphosis, or lordosis) includingidiopathic scoliosis,neuromuscular scoliosis, andcongenital scoliosis. Additionally,the Cortera™ Spinal FixationSystem is intended to treatpediatric patients diagnosed withthe following conditions:spondylolisthesis/spondylolysis,fracture caused by tumor and/ortrauma, pseudarthrosis, and/orfailed previous fusion. Pediatricpedicle screw fixation is limited toa posterior approach.The Cortera™ Spinal FixationSystem is intended to be usedwith an autograft and/or allograft.	The Cortera™ Spinal FixationSystem is intended for posterior,non-cervical fixation in skeletallymature patients as an adjunct tofusion for the followingindications: degenerative discdisease (defined as back pain ofdiscogenic origin withdegeneration of the disc confirmedby history and radiographicstudies); spondylolisthesis; trauma(i.e. fracture or dislocation); spinalstenosis; curvatures (i.e., scoliosis,kyphosis and/or lordosis); tumor;pseudarthrosis; and/or failedprevious fusion.When used for posterior non-cervical pedicle screw fixation inpediatric patients, the Cortera™Spinal Fixation System implantsare indicated as an adjunct tofusion to treat progressive spinaldeformities (i.e. scoliosis,kyphosis, or lordosis) includingidiopathic scoliosis,neuromuscular scoliosis, andcongenital scoliosis. Additionally,the Cortera™ Spinal FixationSystem is intended to treatpediatric patients diagnosed withthe following conditions:spondylolisthesis/spondylolysis,fracture caused by tumor and/ortrauma, pseudarthrosis, and/orfailed previous fusion. Pediatricpedicle screw fixation is limited toa posterior approach.The Cortera™ Spinal FixationSystem is intended to be used withan autograft and/or allograft.	Same.
Regulation /Product Code	21 CFR §888.3070 / NKB	21 CFR §888.3070 / NKB	Same.
TechnologyComparison(continued):	Characteristic	Surgalign Spine TechnologiesCortera Spinal Fixation System(K221403)	Xtant MedicalHoldings, Inc.Cortera™ Spinal FixationSystem(Proposed Device)	Discussion ofDifferences
	Screws	• Solid Polyaxial Pedicle Screws• Cannulated Polyaxial PedicleScrews• Cannulated Polyaxial MISScrews• Solid Polyaxial CorticalCancellous Screws• Cannulated Polyaxial CorticalCancellous Screws• Cannulated Polyaxial CorticalCancellous MIS Screws	• Solid Polyaxial Pedicle Screws• Cannulated Polyaxial PedicleScrews• Cannulated Polyaxial MISScrews• Solid Polyaxial CorticalCancellous Screws• Cannulated Polyaxial CorticalCancellous Screws• Cannulated Polyaxial CorticalCancellous MIS Screws• Solid Polyaxial ReductionPedicle Screws• Cannulated PolyaxialReduction Pedicle Screws• Solid Polyaxial Cortical-Cancellous Reduction Screws• Cannulated Polyaxial Cortical-Cancellous Reduction Screws	This 510(k)includes theaddition ofreduction screws,rod-to-rodconnectors andlateral offsetconnectors to thepredicate deviceCortera SpinalFixation Systemcleared by FDAin K221403.
	CrossConnectors	• Variable Length CrossConnector• Fixed Length Cross connector	• Variable Length CrossConnector• Fixed Length Cross connector
	Rod-to-RodConnectors:	NA	• Open-Open, Open-Side, Closed4 Hole, and Open-Closed,• Titanium Alloy
	Lateral OffsetConnectors	NA	• Lateral Offset and ClosedLateral Offset• Titanium Alloy
	Rods	Rods:• CoCr Straight• CoCr Pre-Bent• Titanium Alloy, Straight• Titanium Alloy, Pre-Bent	Rods:• CoCr Straight• CoCr Pre-Bent• Titanium Alloy, Straight• Titanium Alloy, Pre-Bent
	Cleaning	• Manual, OR• Pre-cleaning, and• Automated washer.	• Manual, OR• Pre-cleaning, and• Automated washer.	Same
	Sterilization	Non-sterile devices provided withvalidated steam sterilizationparameters to ensure a sterilityassurance level (SAL) of 10-6.Parameters:• Cycle: Pre-vacuum (wrapped• Temperature: 132°C (270°F)• Recommended exposure time:4 minutes• Recommended dry time:	Non-sterile devices provided withvalidated steam sterilizationparameters to ensure a sterilityassurance level (SAL) of 10-6.Parameters:• Cycle: Pre-vacuum (wrapped• Temperature: 132°C (270°F)• Recommended exposure time:4 minutes• Recommended dry time:	The sterilizationrecommended drytime was changedfrom 40 minutes(predicate device)to 30 minutes(subject device).

Technology The Cortera™ Spinal Fixation System (Cortera System) employs the same technological characteristics as the predicate device. Comparison:

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Performance Testing:

Reprocessing	The Cortera System was verified and validated for performance in accordance with internal requirements and the following guidance document:
--------------	---------------------------------------------------------------------------------------------------------------------------------------------

FDA Guidance Document: Reprocessing Medical Devices in Health ● Care Settings: Validation Methods and Labeling, dated 17 March 2024.
AAMI/ANSI ST79: 2017, Am1: 2020, Am2: 2020, Am3: 2020, Am4: ● 2020, Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
. ISO 17665-1: 2006, Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.

Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document.

Biocompatibility The Cortera System was verified and validated for performance in accordance with internal requirements and the following guidance document:
- FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", dated 08 September 2023.
- ISO 10993-1: 2018, Biological Evaluation of Medical Devices Part 1: . Evaluation and testing with a risk management process.

Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document.

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Performance Testing (continued):

PerformanceTesting – Bench	The Cortera System was verified and validated for performance inaccordance with internal requirements and the following guidancedocument: FDA Guidance Document: Spinal System 510(k)s, dated 03 May 2004. ASTM F136-13, Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401). ASTM F899-20, Standard Specification for Wrought Stainless Steels forSurgical Instruments. ASTM F1537-20, Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539). ASTM F2063-18, Standard Specification for Wrought Nickel-TitaniumShape Memory Alloys for Medical Devices and Surgical Implants. ASTM F1717-21, Standard Test Methods for Spinal Implant Constructsin a Vertebrectomy Model. ASTM F1798-21, Standard Test Methods for Evaluating Statis andFatigue Properties of Interconnection Mechanisms and SubassembliesUsed in Spinal Arthrodesis Implants. Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document.
Conclusion	Verification and validation activities were conducted to establish theperformance and safety characteristics of the Cortera System. The results ofthese activities demonstrate that the Cortera System is substantiallyequivalent to the predicate device when used in accordance with itsintended use and labeling.Therefore, the Cortera System is considered substantially equivalent to thepredicate device.

PerformanceTesting – Bench

The Cortera System was verified and validated for performance inaccordance with internal requirements and the following guidancedocument: FDA Guidance Document: Spinal System 510(k)s, dated 03 May 2004. ASTM F136-13, Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for SurgicalImplant Applications (UNS R56401). ASTM F899-20, Standard Specification for Wrought Stainless Steels forSurgical Instruments. ASTM F1537-20, Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537,UNS R31538, and UNS R31539). ASTM F2063-18, Standard Specification for Wrought Nickel-TitaniumShape Memory Alloys for Medical Devices and Surgical Implants. ASTM F1717-21, Standard Test Methods for Spinal Implant Constructsin a Vertebrectomy Model. ASTM F1798-21, Standard Test Methods for Evaluating Statis andFatigue Properties of Interconnection Mechanisms and SubassembliesUsed in Spinal Arthrodesis Implants. Verification and validation results indicate that the Cortera System complies with its predetermined specifications and the applicable guidance document.

Conclusion

Verification and validation activities were conducted to establish theperformance and safety characteristics of the Cortera System. The results ofthese activities demonstrate that the Cortera System is substantiallyequivalent to the predicate device when used in accordance with itsintended use and labeling.Therefore, the Cortera System is considered substantially equivalent to thepredicate device.

Regulation Number and Section

N/A