(87 days)
No
The summary describes a mechanical pedicle screw system and its components, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions, which are therapeutic interventions.
No
The device description indicates it is a surgical implant system ("pedicle screw fixation system") used to provide immobilization and stabilization, not to diagnose a condition.
No
The device description explicitly lists physical components such as screws, couplers, set screws, cross links, washers, rods, and hooks, all manufactured from titanium alloy. This indicates it is a hardware-based medical device, not software-only.
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 MonoPoly Pedicle Screw System is for the immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as comprised of physical components like screws, rods, and hooks made from titanium alloy. These are physical implants, not reagents or instruments used to test samples from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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 is indicated for one 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, (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.
Product codes
NKB, KWP, MNH, MNI
Device Description
The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and/or sacral spine (T1-S1), non-cervical posterior spine
Indicated Patient Age Range
skeletally mature 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)
The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974749, K031585, K053573, K061577
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
K081/108 (pg. 1 of 2)
Confidential
April 17, 2008
5. 510(k) Summary according to 807.92(c) JUL 14 2008
| Contact: | Thomas Hoghaug
Signus Medical
18888 Lake Drive East
Chanhassen, MN 55317
952-294-8700 |
|-----------------|---------------------------------------------------------------------------------------------------|
| Trade Name: | MonoPoly Pedicle Screw System |
| Classification: | 21 CFR §888.3070 Pedicle screw spinal system
§888.3050 Spinal interlaminal fixation orthosis |
| Class: | III |
| Product Codes: | NKB KWP MNH MNI |
Indications for Use:
The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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 is indicated for one 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, (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 Description:
The MonoPoly Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws sizes, couplers, a set screw, cross links, a washer, rods and hooks. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).
1
K081108 (pg. 2 of 2)
Signus Medical, LLC MonoPoly Pedicle Screw System 510(k) Confidential
April 17, 2008
Predicate Device(s):
The MonoPoly 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. These devices include the Cross Medical Synergy VLS System (K974749), the U&I Optima Xia System (K031585), The GSS Medical GS System (K053573) and the Signus Medical OvalTwist System (K061577)
Performance Testing:
The pre-clinical testing performed indicated that the MonoPoly Pedicle Screw System is substantially equivalent to predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Signus Medical % Mr. Thomas Hoghaug 18888 Lake Drive East Chanhassen, MN 55317
Re: K081108
Trade/Device Name: MonoPoly Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Names: Pedicie screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Dated: April 17, 2008 Received: April 18, 2008
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 such 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); 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.
JUL 1 4 2008
3
Page 2 - Mr. Thomas Hoghaug
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Confidential
4. Indications for Use
510(k) Number (if known): _ KO81108
Indications for Use:
The MonoPoly Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion 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 spinc in skeletally mature patients, the 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, (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 ﮨﮯ (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)
Salome Brielund Forman
Division Sign Off
Restorative. and Neurological Devices
510(k) Number K081108