The Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
Device Story
Mont Blanc Pedicle Screw System consists of monoaxial and polyaxial pedicle screws and straight rods; traditional saddle design. Used by surgeons in clinical settings to provide spinal immobilization and stabilization as an adjunct to bone graft fusion. Device components interface to secure spinal segments. Benefits include stabilization of the spine in patients with degenerative or traumatic conditions.
Clinical Evidence
Bench testing only. Mechanical testing performed per ASTM F1717, including static and dynamic compression bending and static torsion.
Technological Characteristics
Fabricated from wrought Ti-6Al-4V (ISO 5832-3). System includes monoaxial and polyaxial pedicle screws and straight rods. Traditional saddle design. Mechanical testing conducted per ASTM F1717.
Indications for Use
Indicated for skeletally mature patients requiring noncervical pedicle fixation (T1-S1) as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or failed previous 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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K112684- Page 1 of 2
## 510(k) Summary
Contact:
Dr. Richard Deslauriers Chairman, Qualgenix, LLC (203) 982 - 4239
Device Trade Name:
Mont Blanc Pedicle Screw System
Manufacturer:
Qualgenix, LLC 1 Jack's Hill Rd (Unit 3E) Oxford, CT 06478
Date Prepared:
September 7, 2011
21 CFR §888.3070
NKB, MNH, MNI
111
Pedicle screw spinal system
Common Name:
Classification:
Class:
Product Code:
Indications For Use:
The Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
The Mont Blanc Pedicle Screw System is comprised of a variety of Device Description: monoaxial and polyaxial pedicle screws and rods. The rods are provided straight and intended to interface with the screws, which are traditional saddle design. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. The Mont Blanc Pedicle Screw System is fabricated from wrought Ti-6Al-4V (ISO 5832-3).
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K112684 Page 2 of 2
Predicate Devices:
The Mont Blanc Pedicle Screw System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. Cleared devices include the DePuy MOSS Miami (K962628), Biomet Synergy VLS Open (K973836), Synthes Pangea (K052123) and Zimmer Silhouette (K993067).
#### Performance Testing:
Testing performed indicates the Mont Blanc Pedicle Screw System is substantially equivalent to predicate devices. Testing included mechanical testing per ASTM F1717, including static and dynamic compression bending and static torsion.
Conclusion:
The Mont Blanc Pedicle Screw System has the identical indications for use, intended use, design, and performance compared to predicate devices.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Qualgenix, LLC % Richard Deslauriers, M.D. Chairman 1 Jack's Hill Road, Unit 3E Oxford, Connecticut 06478
MAY - 1 2012
Re: K112684
Trade/Device Name: Mont Blanc Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 28, 2012 Received: March 30, 2012
Dear Dr. Deslauriers:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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## Page 2 - Dr. Richard Deslauriers
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ely yours,
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health ·
Enclosure
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Mont Blanc Pedicle Screw System 510(k)
Confidential
# 4. Indications for Use
510(k) Number (if known): _KIZ684
Device Name: Mont Blanc Pedicle Screw System
The Mont Blanc Pedicle Screw System is intended for noncervical pedice fixation from the T1 to The Mont Blance realer Schew Bybentierts as an adjunct to fusion for the following indications:
\$1 vertebrae in skeletally mature patients as an adjunct to fusion of the 31 vertebrae in skelcully mattre paschack pain of discogenic origin with degeneration of the frequence degenerative use disease (delined as bbin studies); spondylolisthesis; tracture of
disc confirmed by history and radiographic studies); spondylolistes; tracture of uisc cominhed by instery and factory and resplay - 1.
dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
Prescription Use __ V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Cit)
Division of Surgical, Orthopedic, and Restorative Devices
KI12684 510(k) Number.
