(96 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical testing.
Yes
The device is described as a "Spinal Fixation System" intended to provide "immobilization of spinal segments as an adjunct to fusion in the treatment of ... acute and chronic instabilities or deformities." This description implies its use as a medical treatment for specific conditions, which aligns with the definition of a therapeutic device.
No
This device, the KHEIRON Spinal Fixation System, is described as an implantable device used to provide immobilization and support to the spine as an adjunct to fusion. Its purpose is to treat various spinal instabilities and deformities, not to diagnose them.
No
The device description explicitly details physical components made of Ti-6AI-4V ELI alloy, such as screws, anchoring, connecting components, hooks, iliac extensions, and crosslinks, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to provide immobilization and stabilization of the spine. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, hooks, etc., made of a specific alloy. These are physical implants, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status based on in vitro testing.
The KHEIRON Spinal Fixation System is a medical device used in surgical procedures for spinal stabilization and fusion.
N/A
Intended Use / Indications for Use
The KHEIRON® Spinal Fixation System is intended to provide immobilization 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 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, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.
This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The KHEIRON® Spinal Fixation System is used in a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. The KHEIRON Spinal Fixation System includes screws, anchoring, connecting components, hooks, iliac extensions, and crosslinks in a range of sizes and shapes that can be locked in various configurations, with each assembly being tailor-made to the patient's anatomical condition. The KHEIRON pedicle screws must be used with 5.5mm and 6.0mm rods. KHEIRON spinal implants are made of Ti-6AI-4V ELI alloy that conforms to ASTM F136. The KHEIRON Spinal Fixation System is provided clean, non-sterile, and the implants are single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and 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)
Engineering analysis and mechanical testing of the KHEIRON Spinal Fixation System line extension and predicate devices were performed for the purpose of measuring and comparing the mechanical characteristics of the devices. The following mechanical tests were performed:
- Static and dynamic compression bending - ASTM F1717
- Static torsion ASTM F1717
Engineering analyses of various configurations of the KHEIRON Spinal Fixation System determined that a new worst-case was not created by the components of this line extension, relative to the predicate devices. The results of the engineering analyses and mechanical testing indicate that the line extensions, including hooks, iliac extensions, and crosslinks of the KHEIRON Spinal Fixation System are biomechanically equivalent to the predicate devices.
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 10, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance.
S. M. A. I. O % Robert Poggie President BioVera, Inc. 65 Promenade Saint Louis Noltre Dame de L'Ile Perrot, Quebec J7V7P2 Canada
Re: K211414
Trade/Device Name: KHEIRON® Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: May 5, 2021 Received: May 6, 2021
Dear Robert 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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
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
510(k) Number (if known)
Device Name
KHEIRON® Spinal Fixation System
Indications for Use (Describe)
The KHEIRON® Spinal Fixation System is intended to provide immobilization 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 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, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.
This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY for K211414
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following is a summary of safety and effectiveness of S.M.A.I.O.'s KHEIRON Spinal Fixation System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, NDIP, Qu u ébec, J7V 7P2, CANADA |
| Contact Person: | Robert A. Poggie, PhD |
| Phone Number: | 514-901-0796 |
| Fax Number: | 514-901-0796 |
| Date of Submission: | May 4, 2021 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | S.M.A.I.O. |
|---|---|
| Manufacturer Address: | 2, Place Berthe Morisot – Parc Technologique – 69800 SAINT- |
| PRIEST - France | |
| Registration Number: | 3015383864 |
| Contact Name: | Jean-Charles Roussouly |
| Title: | Operations vice-president |
| Device Trade Name: | KHEIRON® Spinal Fixation System |
| Device Common Name: | Pedicle Screw Spinal System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Classification Codes: | Primary code: NKB |
| Additional code: KWP | |
| Classification Panel: | Orthopedic |
| Regulation Number: | Primary regulation: 21 CFR section 888.3070 |
| Additional regulation: 21 CFR section 888.3050 |
C1. PRIMARY PREDICATE DEVICE
- K201659 KHEIRON® Spinal Fixation System
C2. PREDICATE DEVICES K020247 COLORADO 2TM Spinal System, Medtronic Sofamor Danek
4
D. DEVICE DESCRIPTION
The KHEIRON® Spinal Fixation System is used in a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. The KHEIRON Spinal Fixation System includes screws, anchoring, connecting components, hooks, iliac extensions, and crosslinks in a range of sizes and shapes that can be locked in various configurations, with each assembly being tailor-made to the patient's anatomical condition. The KHEIRON pedicle screws must be used with 5.5mm and 6.0mm rods. KHEIRON spinal implants are made of Ti-6AI-4V ELI alloy that conforms to ASTM F136. The KHEIRON Spinal Fixation System is provided clean, non-sterile, and the implants are single-use only.
E. INDICATIONS FOR USE
The KHEIRON® Spinal Fixation System 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, the KHEIRON 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 KHEIRON Spinal Fixation System 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.
F. TECHNOLOGICAL CHARACTERISTICS, COMPARISON TO PREDICATE DEVICE
Intended Use: The KHEIRON Spinal Fixation System, including hooks, iliac extensions, and crosslinks (line extension), and the predicate devices are intended to be used to maintain adequate disc space until fusion occurs.
Indications for Use: The subject and predicate devices comply with the indications for use specified in 21 CFR section 888.3070 for thoracolumbosacral pedicle screw
5
systems. The indications for use statement for the primary predicate and subject devices are identical.
Material: The KHEIRON Spinal Fixation System uses the same material as the predicates (ASTM F136 Ti-6Al-4V alloy).
Design: The KHEIRON Spinal Fixation System and line extension and the predicate devices are substantially equivalent in shape, sizes, material, and manufacturing process.
Strength: The KHEIRON Spinal Fixation System with line extension has greater or substantially equivalent strength values compared to other devices cleared for use in the thoracolumbosacral spine, as demonstrated in performance testing to the predicate devices cited herein.
G. PERFORMANCE DATA
Engineering analysis and mechanical testing of the KHEIRON Spinal Fixation System line extension and predicate devices were performed for the purpose of measuring and comparing the mechanical characteristics of the devices. The following mechanical tests were performed:
- . Static and dynamic compression bending - ASTM F1717
- Static torsion ASTM F1717 ●
Engineering analyses of various configurations of the KHEIRON Spinal Fixation System determined that a new worst-case was not created by the components of this line extension, relative to the predicate devices. The results of the engineering analyses and mechanical testing indicate that the line extensions, including hooks, iliac extensions, and crosslinks of the KHEIRON Spinal Fixation System are biomechanically equivalent to the predicate devices.
H. CONCLUSIONS
The data presented in this 510(k) notification demonstrates that the KHEIRON Spinal Fixation System with line extension components is substantially equivalent to the legally marketed predicate devices.