(104 days)
Not Found
No
The device description and intended use focus solely on mechanical spinal fixation systems and fracture fixation systems, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are related to MR compatibility, not software performance.
Yes
The device descriptions and intended uses clearly state that these systems are designed to provide immobilization, stabilization, and restore integrity of spinal segments and treat fractures, which are all therapeutic functions.
No
The device is described as a "posterior spinal fixation system" and a "fracture fixation" system, indicating its purpose is to provide immobilization and stabilization, not to diagnose conditions.
No
The device description explicitly states that the systems are composed of multiple components including bone anchors (such as screws), longitudinal components (such as rods), and interconnection mechanisms (e.g., set screws), which are all hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The text clearly describes the devices as spinal and bone fixation systems intended for surgical implantation to provide immobilization and stabilization of spinal segments and to treat fractures. These are physical implants used in vivo (within the body), not tests performed in vitro (outside the body).
- Lack of IVD-related terms: The text does not mention any processes or components related to analyzing biological samples, detecting biomarkers, or diagnosing conditions through laboratory testing.
Therefore, the described devices fall under the category of surgical implants or orthopedic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
- · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- · Degenerative disease of the facets with instability.
The SUMMIT and MOUNTAINEER Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.
The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.
The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
- · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- · Degenerative disease of the facets with instability.
The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.
The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.
The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.
The SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, uha, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia.
The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP, HWC, HRS
Device Description
The MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, and SYMPHONY OCT System are posterior spinal fixation systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.
The SUMMIT Fixation System is intended for fracture fixation. The device may be removed after healing of the fracture has occurred. The system includes various lengths of 3 mm rods, 3.5 mm, 4.0 mm and 4.5 mm bone screws, plates, washers, connector plates, pin nuts, and outer nuts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Craniocervical junction, the cervical spine (C1 to C7), thoracic spine (T1-T3), metacarpals, ulna, radius, humerus, metatarsals, lateral malleolus, olecranon, intra-articular distal tibia, pelvis, acetabulum, clavicle, scapula.
Indicated Patient Age Range
Not Found
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 testing was conducted in alignment with the following standards:
- ASTM F2213 Standard Test Method for Measurement of Magnetically Induced . Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2052 Standard Test Method for Measurement of Magnetically Induced ● Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from . Passive Implants
- ASTM F2182 Standard Test Method for Measurement of Radio Frequency . Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Results demonstrated compatibility conditions of the subject devices in the MR environment.
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.
K151885, 151885, K181949, K963350, K980368, K982483
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
July 18, 2019
Medos International SARL % Ms. Sheree Geller Regulatory Affairs Specialist DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767
Re: K190895
Trade/Device Name: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior cervical screw system Regulatory Class: Class II Product Code: NKG, KWP, HWC, HRS Dated: June 18, 2019 Received: June 19, 2019
Dear Ms. Geller:
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.
1
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 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,
Ronald P. Jean, Ph.D. 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
2
Expiration Date: 06/30/2020
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
K190895
Device Name
MOUNTAINEER OCT Spinal System SUMMIT SI OCT Spinal Fixation System
Indications for Use (Describe)
The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
• Instability or deformity;
· Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.
The SUMMIT and MOUNTAINEER Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.
The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.
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) |
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
Expiration Date: 06/30/2020
See PRA Statement below.
Form Approved: OMB No. 0910-0120
Indications for Use
Device Name SYMPHONY OCT System
Indications for Use (Describe)
The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
· Degenerative disease of the facets with instability.
The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.
The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.
The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.
| 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.qov
"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
Expiration Date: 06/30/2020
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name SUMMIT Fixation System
Indications for Use (Describe)
The SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, uha, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia.
The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
| 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) |
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."
5
510(K) SUMMARY
| A. | Submitter Information | |
|---|---|---|
| Manufacturer: | Medos International SARL | |
| Chemin-Blanc 38 | ||
| 2400 Le Locle, Switzerland | ||
| Submitter: | DePuy Synthes Spine | |
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person: | Sheree Geller | |
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Telephone: | ||
| Fax: | ||
| Email: | (508) 828-3291 | |
| (508) 828-3797 | ||
| sgeller1@its.jnj.com | ||
| B. | Date Prepared | March 19, 2019 |
| C. | Device Name | |
| Trade/Proprietary Names: | MOUNTAINEER OCT Spinal System | |
| SUMMIT SI OCT Spinal Fixation System | ||
| SYMPHONY OCT System | ||
| SUMMIT Fixation System | ||
| Common/Usual Names: | Orthosis, Cervical Pedicle Screw Spinal Fixation | |
| Bone Fixation Screws & Plates | ||
| Classification Names: | NKG – Class II – 21 CFR §888.3075 | |
| Posterior Cervical Screw System | ||
| KWP - Class II – 21 CFR §888.3050 Appliance, | ||
| Fixation, Spinal Interlaminal | ||
| HWC – Class II – 21 CFR §888.3040 | ||
| Screw, Fixation, Bone | ||
| HRS – Class II – 21 CFR §888.3030 | ||
| Plate, Fixation, Bone |
6
D. Predicate Device Names
| Primary Predicate: | MOUNTAINEER OCT Spinal System (K151885) |
|---|---|
| Additional Predicates: | SUMMIT SI OCT Spinal Fixation System (151885) |
| SYMPHONY OCT System (K181949) | |
| SUMMIT Fixation System (K963350, K980368, K982483) |
E. Submission Purpose
Obtain clearance for magnetic resonance compatibility labeling of the systems listed.
F. Device Descriptions
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, and SYMPHONY OCT System
The MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, and SYMPHONY OCT System are posterior spinal fixation systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors (e.g., cross connectors) to link the longitudinal components for additional stability.
SUMMIT Fixation System
The SUMMIT Fixation System is intended for fracture fixation. The device may be removed after healing of the fracture has occurred. The system includes various lengths of 3 mm rods, 3.5 mm, 4.0 mm and 4.5 mm bone screws, plates, washers, connector plates, pin nuts, and outer nuts.
G. Intended Use
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System
The SUMMIT SI OCT Spinal Fixation System and MOUNTAINEER OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
7
· Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- · Degenerative disease of the facets with instability.
The SUMMIT and MOUNTAINEER Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The SONGER Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.
The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.
SYMPHONY OCT System
The SYMPHONY OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudarthrosis);
- · Tumors involving the cervical/thoracic spine;
- · Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- · Degenerative disease of the facets with instability.
The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods.
The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine.
The SYMPHONY OCT System may be connected to the EXPEDIUM Spine System and VIPER System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.
8
SUMMIT Fixation System
The SUMMIT Plate System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus, and metatarsals, and in treating fractures of the lateral malleoulus, olecranon, and intra-articular distal tibia.
The SUMMIT Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
Summary of Similarities and Differences in Technological Characteristics, H. Performance, and Intended Use
The subject devices maintain the design characteristics of the predicate devices. Intended use remains consistent with the predicate devices. The subject devices are provided with additional labeling language regarding magnetic resonance (MR) compatibility.
I. Materials
The subject device materials remain identical to the predicate device materials, which consist of Titanium alloy, commercially pure Titanium. Cobalt-Chromium-Molybdenum alloy, and Nitinol.
J. Performance Data
Non-clinical testing was conducted in alignment with the following standards:
- ASTM F2213 Standard Test Method for Measurement of Magnetically Induced . Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2052 Standard Test Method for Measurement of Magnetically Induced ● Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from . Passive Implants
- ASTM F2182 Standard Test Method for Measurement of Radio Frequency . Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Results demonstrated compatibility conditions of the subject devices in the MR environment.
K. Conclusion
Evaluation of subject device intended use and technological characteristics demonstrates substantial equivalence with the predicate devices. Performance data supports the addition of magnetic resonance compatibility information to subject device labeling.