K092073 · Signus Medical · NKB · Aug 7, 2009 · Orthopedic
Device Facts
Record ID
K092073
Device Name
MONOPOLY PEDICLE SCREW SYSTEM
Applicant
Signus Medical
Product Code
NKB · Orthopedic
Decision Date
Aug 7, 2009
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3070
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The MonoPoly Pedicle Screw system is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion in skeletally mature patients of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the MonoPoly Pedicle Screw System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis). When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
Device Story
The MonoPoly Pedicle Screw System is a spinal fixation implant set consisting of monoaxial and polyaxial pedicle screws, couplers, set screws, cross links, washers, rods, and hooks. This submission introduces cannulated versions of the pedicle screw components. The system is used by surgeons in clinical settings to provide immobilization and stabilization of spinal segments as an adjunct to fusion. The implants are manufactured from medical grade titanium alloy (Ti6Al4V-Eli). The device provides mechanical support to the spine to facilitate fusion and stabilize segments affected by degenerative conditions, trauma, or tumors.
Clinical Evidence
Bench testing only. Mechanical properties were evaluated in accordance with ASTM F1717-04.
Technological Characteristics
Materials: Medical grade titanium alloy (Ti6Al4V-Eli). Components: Monoaxial and polyaxial pedicle screws, couplers, set screws, cross links, washers, rods, and hooks. Modification: Introduction of cannulated screw versions. Testing: Mechanical properties evaluated per ASTM F1717-04.
Indications for Use
Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion in the thoracic, lumbar, or sacral spine (T1-S1). Conditions include degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, spinal tumor, spinal stenosis, and pseudarthrosis (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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1090073
## 8 510(k) Summary
·
:
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## AUG 0 7 2009
:
| 510(k) Summary | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Thomas Hoghaug, President<br>Signus Medical LLC<br>18888 Lake Drive East<br>Chanhassen, MN 55317 |
| Contact Person: | Thomas Hoghaug, President<br>Signus Medical LLC<br>18888 Lake Drive East<br>Chanhassen, MN 55317<br>Phone: (952) 294-8700 |
| Date Prepared: | July 7, 2009 |
| Trade Name: | MonoPoly Pedicle Screw System |
| Classification: | 888.3050 (spinal interlaminal fixation orthosis<br>and 888.3070 (pedicle screw spinal system) |
| Product Codes: | NKB, KWP, MNH, MNI. NKB is Class 3; KWP, MNH, and MNI are<br>Class 2. |
| Predicate Device: | MonoPoly Pedicle Screw System |
| Device<br>Description: | The MonoPoly Pedicle Screw System is comprised of a variety of<br>monoaxial and polyaxial pedicle screws sizes, couplers, a set<br>screw, cross links, a washer, rods and hooks. All implantable<br>components are manufactured from medical grade titanium alloy<br>(Ti6Al4V-Eli).<br>premarket notification addresses the introduction<br>of<br>This<br>cannulated versions of the MonoPoly pedicle screw component of<br>the system. |
| 510(k) Summary | |
| Intended Use: | The MonoPoly Pedicle Screw system is intended to help provide<br>immobilization and stabilization of the spinal segments as an<br>adjunct to fusion in skeletally mature patients of the thoracic,<br>lumbar and/or sacral spine (T1-S1), specifically as follows: |
| | When used as a pedicle screw fixation system of the non-cervical<br>posterior spine in skeletally mature patients, the MonoPoly Pedicle<br>Screw System is indicated for one or more of the following: (1)<br>degenerative disc disease (defined as back pain of discogenic<br>origin with degeneration of the disc confirmed by history and<br>radiographic studies) (2) degenerative spondylolisthesis with<br>objective evidence of neurologic impairment, (3) fracture, (4)<br>dislocation, (5) spinal tumor, and/or (6) failed previous fusion<br>(pseudarthrosis). |
| | When used as a non-cervical and non-pedicle screw fixation<br>system, the MonoPoly Pedicle Screw System is intended for the<br>following indications: (1) degenerative disc disease (as defined by<br>back pain of discogenic origin with degeneration of the disc<br>confirmed by patient history and radiographic studies), (2) spinal<br>stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation),<br>(5) pseudarthrosis, (6) tumor resection and/or (7) failed previous<br>fusion. |
| Functional and<br>Safety Testing: | Mechanical properties were evaluated as per ASTM F1717-04. |
| Conclusion: | The modification to the original device does not adversely affect<br>performance and the modified device is substantially equivalent to<br>the unmodified predicate device. |
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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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Signus Medical, LLC % Mr. Thomas Hoghaug President 18888 Lake Drive East Chanhassen, Minnesota 55317
AUG 0 7 2009
Re: K092073
Trade/Device Name: MonoPoly Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KQP Dated: July 7. 2009 Received: July 8, 2009
Dear Mr. Hoghaug
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.
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 requirents, 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 -Mr. Thomas Hoghaug
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
3
ml
Mark N. Melker Director
Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## 7 Indications for Use
510(k) Number (if known):
Device Name: MonoPoly Pedicle Screw System
Indications For Use:
The MonoPoly Pedicle Screw system is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion in skeletally mature patients of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the MonoPoly Pedicle Screw System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal tumor, and/or (6) failed previous fusion (pseudarthrosis).
When used as a non-cervical and non-pedicle screw fixation system, the MonoPoly Pedicle Screw System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) trauma (fracture, dislocation), (5) pseudarthrosis, (6) tumor resection and/or (7) failed previous fusion.
Prescription Use Over-The-Counter Use Prescription Use
(Part 21 CFR 801 Subpart D) (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)
Ez (EXT formKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number k092073
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