(77 days)
Not Found
No
The document describes a spinal implant system and its mechanical testing, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an implant system intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions, which directly addresses medical conditions and aims to restore function.
No
The device is described as an implant system for spinal fusion, intended to provide immobilization. It does not perform diagnostic functions.
No
The device description explicitly states that the device is comprised of titanium alloy and Cobalt-Chrome implants (screws, connectors) and associated instrumentation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Mont Blanc system is a spinal implant system used for immobilization and fusion of spinal segments. This is a surgical device implanted within the body.
- Device Description: The device description details the materials and components of a spinal implant system (screws, rods, connectors).
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Mont Blanc system does not perform any such function.
The device is a surgical implant used to treat structural issues in the spine.
N/A
Intended Use / Indications for Use
The mont blanc system is intended to provide immobilization 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/iliac spine.
This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients:
· 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;
· deformities (i.e., scoliosis, kyphosis, and/or lordosis);
· spinal tumor,
· pseudoarthrosis; and
· failed previous fusion.
The mont blanc system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach."
The mont blanc MIS system is intended to provide immobilization 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.
This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients:
· 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;
· deformities (i.e., scoliosis, kyphosis, and/or lordosis);
· spinal tumor,
· pseudoarthrosis; and
· failed previous fusion.
The mont blanc MIS system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach."
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP
Device Description
The Spineway mont blanc & mont blanc MIS Spinal Systems are implant device systems comprised of a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The fenestrated screws are polyaxial screws in diameters from 5.0 – 8.0 mm and in lengths from 30 – 55 mm. 6 fenestration holes are present in screws of length 35 mm or longer, 3 fenestration holes are present in screws of length 30 mm.
Dual connectors and domino connectors are available to connect 2 parallel rods together, lliac lateral connectors are available to create an Iliac fixation, and Axial connectors are available to connect 2 coaxial rods together.
Associated instrumentation to complete the procedure is provided reusable and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral/iliac spine.
T1 to S1
Indicated Patient Age Range
skeletally mature patients, pediatric patients (adolescent idiopathic scoliosis)
Intended User / Care Setting
Prescription Use
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)
After engineering evaluation of worst-case constructs comprised of Screws, Rods, Locking Screws, & Connectors mechanical testing was performed on the new worst-case constructs. Static Compression Bending, Static Torsion, Torque to Failure and Dynamic Compression Bending per ASTM F1717-15 has been performed to demonstrate substantial equivalence. The result showed that the worst-case constructs were substantially equivalent to legally marketed devices. No clinical or animal 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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 12, 2019
Spineway SA % Tamala J. Wampler Regulatory and Quality Consultant Novus Management Group LLC 6686 Dimmick Road West Chester, Ohio 45069
Re: K191726
Trade/Device Name: mont blanc & mont blanc MIS Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: May 3, 2019 Received: June 27, 2019
Dear Ms. Wampler:
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
1
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 (OS) 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,
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191726
Device Name mont blanc spinal system
Indications for Use (Describe)
The mont blanc system is intended to provide immobilization 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/iliac spine.
This mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients:
· 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;
- · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- · spinal tumor,
- · pseudoarthrosis; and
- · failed previous fusion.
The mont blanc system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach."
| Type or 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
Indications for Use
510(k) Number (if known) K191726
Device Name mont blanc MIS spinal system
Indications for Use (Describe)
The mont blanc MIS system is intended to provide immobilization 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.
This mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a percutaneous minimally approach for the following indications in skeletally mature patients:
· 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;
- · deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- · spinal tumor,
- · pseudoarthrosis; and
- · failed previous fusion.
The mont blanc MIS system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Mont Blanc and Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograff. 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
4
510(k) Summary
| Submitter's Name: | Spineway SA |
|---|---|
| Submitter's Address: | 7 Allee Moulin Berger |
| 69130 Ecully Rhone-Alpes, FRANCE | |
| Submitter's Telephone: | (513) 593-4944 |
| Company Contact Person: | Héloïse MACAIRE |
| Regulatory Affairs Specialist | |
| Contact Person: | Tamala J. Wampler |
| Novus Management Group LLC. | |
| 513-593-4944 | |
| Date Summary was Prepared: | 10/14/2018 |
| Trade or Proprietary Name: | mont blanc & mont blanc MIS Spinal Systems |
| Common or Usual Name: | Thoracolumbosacral pedicle screw system |
| Classification: | Class II per 21 CFR §888.3070 |
| Product Code: | NKB, KWP |
| Classification Panel: | Division of Orthopedic Devices |
| Panel Code: | 87 |
Description of the Device Subject to Premarket Notification:
The Spineway mont blanc & mont blanc MIS Spinal Systems are implant device systems comprised of a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The fenestrated screws are polyaxial screws in diameters from 5.0 – 8.0 mm and in lengths from 30 – 55 mm. 6 fenestration holes are present in screws of length 35 mm or longer, 3 fenestration holes are present in screws of length 30 mm.
Dual connectors and domino connectors are available to connect 2 parallel rods together, lliac lateral connectors are available to create an Iliac fixation, and Axial connectors are available to connect 2 coaxial rods together.
Associated instrumentation to complete the procedure is provided reusable and non-sterile.
Indications for Use mont blanc system
The mont blanc system is intended to provide immobilization 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/iliac spine.
The mont blanc system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) for the following indications in skeletally mature patients:
- . 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;
- deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- . spinal tumor,
- pseudoarthrosis; and
- failed previous fusion.
5
The mont blanc system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
INDICATIONS FOR USE MONT BLANC MIS SYSTEM
The mont blanc MIS system is intended to provide immobilization 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 mont blanc MIS system is intended for posterior noncervical pedicle fixation and non-pedicle fixation (from T1 to S1) utilizing a minimally approach for the following indications in skeletally mature patients:
- . 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;
- deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- spinal tumor,
- pseudoarthrosis; and
- failed previous fusion.
The mont blanc MIS system is intended to be used with autograft and/or allograft.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Mont Blanc and Mont Blanc MIS Spinal Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Mont Blanc MIS Spinal Systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
PREDICATES
mont blanc & mont blanc MIS Spinal Systems are substantially equivalent to the mont blanc MIS Spinal Systems (K161387). mont blanc & mont blanc MIS are provided sterile as was cleared in mont blanc & mont blanc Spinal System (K161387). The mont blanc MIS Spinal Systems also includes bullet shaped rods, pre-bent rods and cobalt-chrome rods cleared in mont blanc Spinal System (K161387). The subject and predicate devices have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use (identical to Primary)
- Materials of manufacture (identical to Primary and Secondary's)
- Structural support mechanism (identical to Primary and Secondary's) ●
Table 5-1 Predicate Devices
6
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K161387 | mont blanc & mont blanc MIS Spinal | ||
| Systems | Spineway | Primary | |
| K131802 | EXPEDIUM® Spine System, VIPER and | ||
| VIPER2 Systems | Medos International Sarl | Secondary | |
| K071373 | Stryker Spine Xia® III Spinal System | Stryker Spine | Secondary |
PERFORMANCE TESTING
Spineway's mont blanc & mont blanc MIS Spinal Systems were evaluated to demonstrate equivalence to the predicate devices. After engineering evaluation of worst-case constructs comprised of Screws, Rods, Locking Screws, & Connectors mechanical testing was performed on the new worst-case constructs. Static Compression Bending, Static Torsion, Torque to Failure and Dynamic Compression Bending per ASTM F1717-15 has been performed to demonstrate substantial equivalence.
The result showed that the worst-case constructs were substantially equivalent to legally marketed devices. No clinical or animal studies were performed.
Conclusion
Spineway concludes that the mont blanc MIS Spinal Systems expanded equipment is substantially equivalent to their already marketed configurations in regard to indications for use, materials, function, sizes and mechanical test results and can therefore be added to the mont blanc & mont blanc MIS Spinal Systems without new questions of safety or effectiveness.