(35 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "Spinal Fixation System" intended to provide "immobilization and stabilization of spinal segments as an adjunct to fusion" for various spinal conditions, which directly relates to treating or alleviating human ailments.
No
The Cortera™ Spinal Fixation System is described as a "thoracolumbosacral pedicle screw system" intended for "immobilization and stabilization of spinal segments as an adjunct to fusion." Its components include screws, rods, and connectors used in surgical procedures. This description indicates it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of screws, rod-to-rod connectors, lateral offset connectors, rods, locking set screws, and associated reusable manual surgical instruments, all of which are physical hardware components.
Based on the provided text, the Cortera™ Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Cortera™ Spinal Fixation System is a surgical implant intended for posterior spinal fixation. It is a physical device implanted into the body to stabilize the spine.
The description clearly states its purpose is to provide "immobilization and stabilization of spinal segments as an adjunct to fusion." This is a therapeutic and structural function, not a diagnostic one based on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Cortera™ Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); 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.
Product codes
NKB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments of the thoracic, lumbar and/or the sacral spine.
Indicated Patient Age Range
Skeletally mature patients; pediatric patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Performance Testing – Bench: The Cortera System was verified and validated for performance in accordance with internal requirements and the following guidance document: FDA Guidance Document: Spinal System 510(k)s, dated 03 May 2004. ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). ASTM F899-20, Standard Specification for Wrought Stainless Steels for Surgical 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-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. ASTM F1717-21, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. ASTM F1798-21, Standard Test Methods for Evaluating Statis 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.
Conclusion: 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. Therefore, the Cortera System is considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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).
1
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
2
Indications for Use
Submission Number (if known)
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)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
K241892 Page 1 of 1
3
| Submission
| Date: | 28 June 2024 | ||
|---|---|---|---|
| Submitter: | Xtant Medical Holdings, Inc. | ||
| 664 Cruiser Lane | |||
| Belgrade, MT 59714 | |||
| Submitter and | |||
| Official | |||
| Contact: | Ms. Rebecca Lennemann | ||
| Director, RA/QA | |||
| Xtant Medical Holdings, Inc. | |||
| 664 Cruiser Lane | |||
| Belgrade, MT 59714 | |||
| +1 (406) 924-5878 | |||
| rlennemann@xtantmedical.com | |||
| Manufacturing | |||
| Site: | Xtant Medical Holdings, Inc. | ||
| 664 Cruiser Lane | |||
| Belgrade, MT 59714 | |||
| Trade Name: | Cortera™ Spinal Fixation System | ||
| Classification | |||
| Name: | Thoracolumbosacral pedicle screw system | ||
| Classification | |||
| Regulation / | |||
| Product Code | 21 CFR §888.3070 / NKB | ||
| Substantially | |||
| Equivalent | |||
| Devices: | Proposed Xtant | ||
| Medical Model | Predicate 510(k) | ||
| Number | Predicate Manufacturer / Model | ||
| Cortera™ Spinal | |||
| Fixation System | K221403 | Surgalign Spine Technologies / | |
| Cortera Spinal Fixation System | |||
| (Primary Predicate) | |||
| K192800 | Pioneer Surgical Technology, Inc. | ||
| (DBA RTI Surgical, Inc.) / | |||
| Streamline TL Spinal Fixation | |||
| System (Additional Predicate) |
4
| 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. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use: | The CorteraTM 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 CorteraTM 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 CorteraTM 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 CorteraTM Spinal Fixation System is intended to be used with an
autograft and/or allograft. |
5
| Characteristic | Surgalign Spine Technologies
Cortera Spinal Fixation System
(K221403) | Xtant Medical
Holdings, Inc.
Cortera™ Spinal Fixation
System
(Proposed Device) | Discussion of
Differences | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Cortera™ Spinal Fixation
System is intended for posterior,
non-cervical fixation in skeletally
mature patients as an adjunct to
fusion for the following
indications: degenerative disc
disease ( defined as back pain of
discogenic origin with
degeneration of the disc confirmed
by history and radiographic
studies); spondylolisthesis; trauma
(i.e. fracture or dislocation); spinal
stenosis; curvatures (i.e., scoliosis,
kyphosis and/or lordosis); tumor;
pseudarthrosis; and/or failed
previous fusion.
When used for posterior non-
cervical pedicle screw fixation in
pediatric patients, the Cortera™
Spinal Fixation System implants
are indicated as an adjunct to
fusion to treat progressive spinal
deformities (i.e. scoliosis,
kyphosis, 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. | 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. | Same. | |
| Regulation /
Product Code | 21 CFR §888.3070 / NKB | 21 CFR §888.3070 / NKB | Same. | |
| Technology
Comparison
(continued): | Characteristic | Surgalign Spine Technologies
Cortera Spinal Fixation System
(K221403) | Xtant Medical
Holdings, Inc.
Cortera™ Spinal Fixation
System
(Proposed Device) | Discussion of
Differences |
| | Screws | • Solid Polyaxial Pedicle Screws
• Cannulated Polyaxial Pedicle
Screws
• Cannulated Polyaxial MIS
Screws
• Solid Polyaxial Cortical
Cancellous Screws
• Cannulated Polyaxial Cortical
Cancellous Screws
• Cannulated Polyaxial Cortical
Cancellous MIS Screws | • Solid Polyaxial Pedicle Screws
• Cannulated Polyaxial Pedicle
Screws
• Cannulated Polyaxial MIS
Screws
• Solid Polyaxial Cortical
Cancellous Screws
• Cannulated Polyaxial Cortical
Cancellous Screws
• Cannulated Polyaxial Cortical
Cancellous MIS Screws
• Solid Polyaxial Reduction
Pedicle Screws
• Cannulated Polyaxial
Reduction Pedicle Screws
• Solid Polyaxial Cortical-
Cancellous Reduction Screws
• Cannulated Polyaxial Cortical-
Cancellous Reduction Screws | This 510(k)
includes the
addition of
reduction screws,
rod-to-rod
connectors and
lateral offset
connectors to the
predicate device
Cortera Spinal
Fixation System
cleared by FDA
in K221403. |
| | Cross
Connectors | • Variable Length Cross
Connector
• Fixed Length Cross connector | • Variable Length Cross
Connector
• Fixed Length Cross connector | |
| | Rod-to-Rod
Connectors: | NA | • Open-Open, Open-Side, Closed
4 Hole, and Open-Closed,
• Titanium Alloy | |
| | Lateral Offset
Connectors | NA | • Lateral Offset and Closed
Lateral 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 with
validated steam sterilization
parameters to ensure a sterility
assurance 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 with
validated steam sterilization
parameters to ensure a sterility
assurance level (SAL) of 10-6.
Parameters:
• Cycle: Pre-vacuum (wrapped
• Temperature: 132°C (270°F)
• Recommended exposure time:
4 minutes
• Recommended dry time: | The sterilization
recommended dry
time was changed
from 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:
6
7
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.
8
Performance Testing (continued):
| Performance
Testing – Bench | The Cortera System was verified and validated for performance in
accordance with internal requirements and the following guidance
document: FDA Guidance Document: Spinal System 510(k)s, dated 03 May 2004. ASTM F136-13, Standard Specification for Wrought Titanium-6
Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
Implant Applications (UNS R56401). ASTM F899-20, Standard Specification for Wrought Stainless Steels for
Surgical 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-Titanium
Shape Memory Alloys for Medical Devices and Surgical Implants. ASTM F1717-21, Standard Test Methods for Spinal Implant Constructs
in a Vertebrectomy Model. ASTM F1798-21, Standard Test Methods for Evaluating Statis 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. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | 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.
Therefore, the Cortera System is considered substantially equivalent to the
predicate device. |