KHEIRON® Spinal Fixation System, including patient specific K-ROD
Applicant
S.M.A.I.O
Product Code
NKB · Orthopedic
Decision Date
Sep 4, 2026
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
KHEIRON® Spinal Fixation System including patient specific K-ROD is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is 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, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.This system is intended to be used with autograft and/or allograft.Pediatric pedicle screw fixation is limited to a posterior approach.When connected to compatible pedicle screw systems, the patient specific K-ROD is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.Please refer to the additional information section of the most up-to-date Instructions for Use on compatible pedicle screw systems.
Device Story
Patient-specific spinal rod (K-ROD) component of KHEIRON® Spinal Fixation System; provides immobilization/stabilization of thoracic, lumbar, and sacral spine segments as adjunct to fusion. Device manufactured from Ti-6Al-4V ELI (ASTM F136) or Co-28Cr-6Mo (ASTM F1537). Modification expands compatibility of K-ROD with third-party pedicle screw systems (Silony VERTICALE®, Orthofix Mariner, Highridge Vital, DePuy Synthes Expedium/TriAltis, Orthofix Virata). Used by surgeons in clinical settings to maintain spinal alignment/shape until fusion occurs. Output is mechanical stabilization of spinal segments.
Clinical Evidence
Bench testing only. Mechanical verification performed per ASTM F1717 (dynamic compression) and ASTM F1798 (static axial/torsional gripping capacity). Results confirm mechanical strength is equivalent to primary predicate devices.
Technological Characteristics
Materials: Ti-6Al-4V ELI (ASTM F136) or Co-28Cr-6Mo (ASTM F1537). Form factor: Patient-specific spinal rods, 5.5mm and 6.0mm diameters. Mechanical fixation via pedicle screw system interface. Sterilization: Not specified. Connectivity: N/A (mechanical implant).
Indications for Use
Indicated for skeletally mature patients with acute/chronic spinal instabilities or deformities (DDD, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, stenosis, tumor, pseudarthrosis, failed fusion). Also indicated for pediatric patients (posterior approach only) for progressive spinal deformities (idiopathic, neuromuscular, congenital scoliosis), spondylolisthesis/spondylolysis, fracture, pseudarthrosis, and failed fusion.
Regulatory Classification
Identification
(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
Special Controls
*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 4, 2026
S.M.A.I.O
% Robert A. Poggie
President
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L'Île-Perrot, QC J7W 3J6
Canada
Re: K262828
Trade/Device Name: KHEIRON® Spinal Fixation System, including patient specific K-ROD
Regulation Number: 21 CFR 888.3070
Regulation Name: Thoracolumbosacral pedicle screw system
Regulatory Class: Class II
Product Code: NKB, KWP
Dated: August 10, 2026
Received: August 10, 2026
Dear Robert A. Poggie:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262828 - Robert A. Poggie
Page 2
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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
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K262828 - Robert A. Poggie
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
COLIN O'NEILL -S
Colin O'Neill, M.B.E.
Assistant Director
DHT6B: Division of Spinal Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262828 | ? |
| Please provide the device trade name(s). | | ? |
| KHEIRON® Spinal Fixation System, including patient specific K-ROD | | |
| Please provide your Indications for Use below. | | ? |
| KHEIRON® Spinal Fixation System including patient specific K-ROD is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is 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, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.This system is intended to be used with autograft and/or allograft.Pediatric pedicle screw fixation is limited to a posterior approach.When connected to compatible pedicle screw systems, the patient specific K-ROD is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.Please refer to the additional information section of the most up-to-date Instructions for Use on compatible pedicle screw systems. | | |
| Please select the types of uses. | Prescription Use (21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? |
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K262828- Page 1 of 4
510(k) #:
# 510(k) Summary
Prepared on: 2026-09-04
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | S.M.A.I.O |
| --- | --- |
| Applicant Address | 2 place Berthe Morisot Saint-Priest 69800 France |
| Applicant Contact Telephone | +33670165171 |
| Applicant Contact | Mr. Jean-Charles Roussouly |
| Applicant Contact Email | jc.roussouly@smaio.com |
| Correspondent Name | BioVera, Inc. |
| Correspondent Address | 65 Promenade Saint Louis Notre-Dame-de-L'Ile-Perrot QC J7W3J6 United States |
| Correspondent Contact Telephone | (514) 349-7226 |
| Correspondent Contact | Dr. Robert A. Poggie |
| Correspondent Contact Email | orthobob@biovera.ca |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | KHEIRON® Spinal Fixation System, including patient specific K-ROD |
| --- | --- |
| Common Name | Thoracolumbosacral pedicle screw system |
| Classification Name | Thoracolumbosacral Pedicle Screw System |
| Regulation Number | 888.3070 |
| Product Code(s) | NKB, KWP |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K211981 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB |
| K253802 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB |
| K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | NKB |
| K222110 | Mariner RDX System | NKB |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB |
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K262828- Page 2 of 4
| K240539 | Vital™ Spinal Fixation System | NKB |
| --- | --- | --- |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB |
| K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | NKB |
| K231479 | TriALTIS Spine System | NKB |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB |
| K250908 | Virata Spinal Fixation System | NKB |
| K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB |
| K232650 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | NKB |
## Device Description Summary
21 CFR 807.92(a)(4)
S.M.A.I.O.'s patient specific K-ROD is part of the 510(k) cleared KHEIRON® Spinal Fixation system (K211981, K232650, K251804, K253721, K253802, K253990, K260786) designed for stabilization and correction of chronic instability or deformity of the thoracic, lumbar, and sacral spine. The patient specific K-ROD is manufactured from Ti-6Al-4V ELI per ASTM F136 or Co-28Cr-6Mo per ASTM 1537 and is available in diameters of 5.5 and 6.0 mm.
The Ti-6Al-4V ELI patient-specific K-ROD was cleared under K211981 and has subsequently been cleared for use with the NuVasive Reline System under K232650, the Orthofix Mariner System under K251804, the Highridge Vital System under K253721, the DePuy Synthes Expedium and TriAltis Systems under K253990, and the Orthofix Virata System under K260786. The Co-28Cr-6Mo patient-specific K-ROD, as an extension of the KHEIRON® Spinal Fixation System, was cleared under K253802.
The Silony VERTICALE® System is a 510(k) cleared pedicle screw system (K171421) that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors, and general instruments. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The Silony VERTICALE® System is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The VERTICALE® System is intended for non-cervical pedicle fixation and nonpedicle fixation 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The purpose of this Special 510(k) Device Modification is:
1-To add the compatibility of the Co-28Cr-6Mo patient-specific K-ROD, cleared under K253802, with the Orthofix Mariner System (K222110), the Highridge Vital System (K240539), the DePuy Synthes Expedium and TriAltis Systems (K200245 and K231479), and the Orthofix Virata System (K250908), for which compatibility with the Ti-6Al-4V ELI patient-specific K-ROD was previously cleared under K251804, K253721, K253990, and K260786, respectively.
2-To extend indication of S.M.A.I.O.'s Ti-6Al-4V and Co-28Cr-6Mo patient specific K-ROD (K211981, K232650, K251804, K253721, K253802, K253990, K260786) for use with the Silony VERTICALE® System (K171421).
## Intended Use/Indications for Use
21 CFR 807.92(a)(5)
KHEIRON® Spinal Fixation System including patient specific K-ROD is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
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K262828- Page 3 of 4
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, KHEIRON® Spinal Fixation System including patient specific K-ROD is 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, KHEIRON® Spinal Fixation System including patient specific K-ROD is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.
This system is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach.
When connected to compatible pedicle screw systems, the patient specific K-ROD is 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 thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
Please refer to the additional information section of the most up-to-date Instructions for Use on compatible pedicle screw systems.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use of the subject device are identical to those of the predicate devices, except for the addition of compatibility with the Silony VERTICALE® System (K171421) and the addition of compatibility of the Co-28Cr-6Mo patient-specific K-ROD with spinal fixation systems for which compatibility with the Ti-6Al-4V ELI patient-specific K-ROD was previously established.
More specifically, the Ti-6Al-4V ELI patient-specific K-ROD was cleared under K211981 and compatibility with the following spinal fixation systems was subsequently established: the NuVasive Reline System under K232650, the Orthofix Mariner System under K251804, the Highridge Vital System under K253721, the DePuy Synthes Expedium and TriAltis Systems under K253990, and the Orthofix Virata Spinal Fixation System under K260786. The Co-28Cr-6Mo patient-specific K-ROD was cleared under K253802.
This 510(k) establishes compatibility of the Co-28Cr-6Mo patient-specific K-ROD with the Orthofix Mariner System (K222110), the Highridge Vital System (K240539), the DePuy Synthes Expedium and TriAltis Systems (K200245 and K231479), and the Orthofix Virata Spinal Fixation System (K250908), as well as compatibility of both the Ti-6Al-4V ELI and Co-28Cr-6Mo patient-specific K-RODs with the Silony VERTICALE® System (K171421).
## Technological Comparison
21 CFR 807.92(a)(6)
The patient specific K-ROD subject device is identical to the patient specific K-ROD cleared in K211981, K232650, K251804, K253721, K253802, K253990 and K260786. The components of the Silony VERTICALE® System that interface with the patient specific K-ROD are identical to those cleared in K171421. The components of the Orthofix Mariner System, Highridge Vital System, DePuy Synthes Expedium and TriAltis Systems, and Orthofix Virata Spinal Fixation System that interface with the patient-specific K-ROD are identical to the corresponding components cleared under K222110, K253093, K222473 and K253249, and K250908, respectively.
The purpose of this Special 510(k) is to summarize in DCAS format the V&V activities demonstrating that the Ti-6Al-4V and Co-28Cr-6Mo K-ROD can be used with the Silony VERTICALE® System and that the Co-28Cr-6Mo patient-specific K-ROD can be used with the applicable components of the Orthofix Mariner, Highridge Vital, DePuy Synthes Expedium and TriAltis, and Orthofix Virata spinal fixation systems.
For the compatibility of the Ti-6Al-4V and Co-28Cr-6Mo K-ROD and the Silony VERTICALE® System:
Intended Use: K-RODs used in conjunction with the Silony VERTICALE® System, and the predicate devices are intended to be used to maintain spine shape until fusion occurs.
Indications for Use: The indications for use statement for the primary predicate and subject devices are the same.
Material: K-RODs used in conjunction with the Silony VERTICALE® System uses the same material as the predicates (ASTM F136 Ti-6Al-4V alloy or ASTM 1537 Co-28Cr-6Mo). The manufacturing processes, including cleaning and passivation, are the same for the titanium alloy and CoCrMo alloy K-RODs per the referenced 510K clearances.
Design: K-RODs used in conjunction with the Silony VERTICALE® System and the predicate devices are substantially equivalent in shape, sizes, material, and manufacturing process.
Strength: K-ROD used with the Silony VERTICALE® System has similar strength as the primary predicate K-ROD per verification and validation activities summarized later herein in DCAS table format.
For the compatibility of the Co-28Cr-6Mo patient-specific K-ROD with the Orthofix Mariner System, Highridge Vital System, DePuy Synthes Expedium and TriAltis Systems, and Orthofix Virata Spinal Fixation System:
Intended Use: The Co-28Cr-6Mo patient-specific K-ROD used in conjunction with the Orthofix Mariner System, Highridge Vital System,
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DePuy Synthes Expedium and TriAltis Systems, and Orthofix Virata Spinal Fixation System, and the corresponding predicate devices, are intended to maintain spinal alignment until fusion occurs.
Indications for Use: The indications for use statements for the subject device and the corresponding predicate devices are the same. Material: The Co-28Cr-6Mo patient-specific K-ROD used in conjunction with the Orthofix Mariner System, Highridge Vital System, DePuy Synthes Expedium and TriAltis Systems, and Orthofix Virata Spinal Fixation System is manufactured from Co-28Cr-6Mo conforming to ASTM F1537, consistent with the patient-specific K-ROD cleared under K253802. Materials and manufacturing processes remain the same as cleared in K253802, K253721, K253990, and K260786.
Design: The Co-28Cr-6Mo patient-specific K-ROD used in conjunction with the Orthofix Mariner System, Highridge Vital System, DePuy Synthes Expedium and TriAltis Systems, and Orthofix Virata Spinal Fixation System and the corresponding predicate devices are substantially equivalent in shape, sizes, material, and manufacturing process.
Strength: The Co-28Cr-6Mo patient-specific K-ROD used with the Orthofix Mariner System, Highridge Vital System, DePuy Synthes Expedium and TriAltis Systems, and Orthofix Virata Spinal Fixation System has similar strength as the primary predicate K-ROD per verification and validation activities summarized later herein in DCAS table format.
## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Engineering analysis and mechanical testing of Ti-6Al-4V K-RODs used with the Silony VERTICALE® System were performed to verify and validate the mechanical characteristics of the expanded use of patient specific K-RODs. The following mechanical tests were performed as part of the V&V activities:
- Dynamic compression – ASTM F1717
- Static axial gripping capacity – ASTM F1798
- Static torsional gripping capacity – ASTM F1798
The ASTM F1717 and F1798 tests performed for V&V of K-ROD used with the Silony VERTICALE® System were identical in set-up and test parameters as presented in K211981. Engineering analysis comparing K-ROD and Silony VERTICALE® System's titanium alloy rods determined that a new worst-case was not created for the K-ROD used with the Silony VERTICALE® System relative to the primary predicate K-ROD (K211981) and predicate Silony VERTICALE® System (K171421) devices.
Mechanical testing of Co-28Cr-Mo K-RODs (K253802) used with the Orthofix Mariner System (K222110), the Highridge Vital System (K240539), the DePuy Synthes Expedium and TriAltis Systems (K200245 and K231479), and the Orthofix Virata System (K250908), for which compatibility with the Ti-6Al-4V ELI patient-specific K-ROD was previously cleared under K251804, K253721, K253990, and K260786, respectively, and with the Silony VERTICALE® System (K171421) were performed to verify and validate the mechanical characteristics of the expanded use of patient specific CoCrMo alloy K-RODs. The following mechanical tests were performed as part of the V&V activities:
- Static axial gripping capacity – ASTM F1798
- Static torsional gripping capacity – ASTM F1798
The ASTM F1798 tests performed for V&V of CoCrMo K-ROD used with the above listed company systems were identical in set-up and test parameters as presented in K253802. The results of testing showed no new worst case relative to that presented in K253802.
The information presented in this Special 510(k) Device Modification demonstrates that the KHEIRON® Spinal Fixation System, including patient specific K-ROD, is compatible with the Spinal Systems described in this 510(k) and is substantially equivalent to the legally marketed predicate devices.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the ? button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only Software as a Medical Device, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (Software as a Medical Device), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
