(109 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a spinal fixation system intended to provide immobilization as an adjunct to fusion for treating spinal instabilities and deformities, rather than directly applying therapy.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It directly treats conditions rather than diagnosing them.
No
The device description explicitly states that the KHEIRON Spinal Fixation System includes "screws and connecting components," which are physical hardware implants.
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 device used for surgical implantation 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 and connecting components, which are typical of surgical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties (compression, bending, torsion) relevant to the structural integrity of an implant, not diagnostic accuracy metrics like sensitivity or specificity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The KHEIRON Spinal Fixation System does not fit this description.
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 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 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 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 (comma separated list FDA assigned to the subject device)
NKB
Device Description
The KHEIRON® Spinal Fixation System may be used for 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. KHEIRON Spinal Fixation System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.
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)
Non-clinical Test Summary: Static and dynamic compression bending and static torsion (ASTM F1717) and torsional and axial gripping capacity (ASTM F1798) was performed. The results of these evaluations indicate that the KHEIRON Spinal Fixation System is substantially equivalent to legally marketed predicate devices.
Clinical Test Summary: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K143633 / K124058 / K113395, K940631 / K950099, K920116, K000536, K955348, K954696
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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October 5, 2020
S.M.A.I.O. % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K201659
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 Dated: August 26, 2020 Received: August 28, 2020
Dear J.D. Webb:
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
1
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 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 medical devices and radiation-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) K201659
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 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 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 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) | |
|---|---|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: KHEIRON® Spinal Fixation System
| Date Prepared | August 26, 2020 |
|---|---|
| Submitted By | S.M.A.I.O. |
| 2, Place Berthe Morisot - Parc Technologique | |
| 69800 SAINT-PRIEST | |
| FRANCE |
- 33 (0) 4 69 84 28 02 Tele |
| Primary Contact | J.D. Webb
4313 W. 3800 S
West Haven, UT 84401
512-590-5810 Tele
e-mail: jdwebb@orthomedix.net |
| Trade Name | KHEIRON® Spinal Fixation System |
| Common Name | Thoracolumbosacral Pedicle Screw System |
| Classification Name | Thoracolumbosacral Pedicle Screw System |
| Class | ll |
| Product Code | NKB |
| CFR Section | 21 CFR section 888.3070 |
| Device Panel | Orthopedic |
| Primary Predicate
Device | COLORADO 2™ Spinal System, Medtronic Sofarnor Danek (K020247) |
| Reference Predicate
Devices | Revere® / CREO™ Stabilization System, Globus Medical (K143633 / K124058 / K113395)
Synergy VLS - open, Cross Medical (K940631 / K950099)
PWB (now Synergy), Cross Medical (K920116)
Moss Miami SS, DePuy Spine (K000536)
Moss Miami Ti, DePuy Spine (K955348)
Rogozinski Thoracolumbar Spinal Rod, SMITH & NEPHEW (K954696) |
| Device Description | The KHEIRON® Spinal Fixation System may be used for 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. KHEIRON
Spinal Fixation System includes screws and connecting components in a wide variety of
sizes and shapes, which can be locked in various configurations, each assembly being
tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods. |
| Materials | Ti-6Al-4V ELI per ASTM F136 |
| Intended Use | The KHEIRON Fixation System is a spinal fixation system intended to help provide
immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic,
lumbar, and/or sacral spine. |
| Substantial
Equivalence Claimed
to Predicate Devices | The KHEIRON Fixation System is substantially equivalent to the predicate devices in
terms of intended use, design, materials used, mechanical safety and performances. |
| 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) 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. |
| Summary of the
technological
characteristics
compared to
predicate | Intended Use
The KHEIRON Spinal Fixation System and the predicate devices are all intended to be
used to maintain adequate disc space until fusion occurs. |
| | Indications for Use
All of the devices comply with the indications for use specified in 21 CFR section 888.3070
for thoracolumbosacral pedicle screw systems. |
| | Material
The KHEIRON Spinal Fixation System uses the same material as the predicates. |
| | Design
The KHEIRON Spinal Fixation System and the predicates are equivalent in terms of
shape, sizes, material, and manufacturing process. |
| | Strength
The KHEIRON Spinal Fixation System has greater or equivalent strength values
compared to other devices cleared for use in the thoracolumbosacral spine. |
| Non-clinical Test
Summary | Static and dynamic compression bending and static torsion (ASTM F1717) and torsional
and axial gripping capacity (ASTM F1798) was performed. |
| | The results of these evaluations indicate that the KHEIRON Spinal Fixation System is
substantially equivalent to legally marketed predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | S.M.A.I.O. considers the KHEIRON Spinal Fixation System to be substantially equivalent
to the legally marketed predicate devices listed above. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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