(27 days)
Not Found
No
The device description and intended use focus on mechanical components for spinal fusion. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is an implantable spinal system designed to promote fusion, which is a structural and mechanical intervention, not a therapeutic treatment.
No
The MOUNTAINEER OCT Spinal System is described as a system of implants (plates, screws, rods, etc.) intended to promote fusion of the cervical spine and occipitocervico-thoracic junction. Its indications for use describe conditions requiring surgical intervention, not diagnosis. It does not perform any analytical function to determine the presence or nature of a disease.
No
The device description explicitly lists physical components made of Titanium Alloy and Cobalt-Chromium-Molybdenum alloy, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The MOUNTAINEER OCT Spinal System is a collection of implants (plates, screws, rods, etc.) designed to be surgically implanted into the cervical and thoracic spine to promote fusion and provide stability. Its intended uses are for treating structural issues like DDD, spondylolisthesis, fractures, and tumors.
- Lack of Diagnostic Function: The description and intended use clearly indicate that this device is a surgical implant used for treatment and stabilization, not for analyzing biological samples to diagnose a condition.
Therefore, based on the provided information, the MOUNTAINEER OCT Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Atlanto/axial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical spine surgery
- Tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The SONGER® wire/cable system to be used with the MOUNTAINEER® OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM systems using the dual wedding band and axial connectors, and via dual diameter rods.
Product codes
KWP, MNI
Device Description
The MOUNTAINEER® OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, lateral offset connectors, head-to-head connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws, monoaxial screws, hooks, and SONGER® Cables. The components are manufactured from Titanium Alloy.
The MOUNTAINEER® OCT Spinal System Longitudinal rods are also available in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537. Cobaltchromium-molybdenum alloy rods are intended for use with titanium components only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipitocervico-thoracic junction (occiput-T3), upper thoracic spine (T1-T3)
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)
Performance data is not provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041203, K042508, K080828, and K110353
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
510(K) SUMMARY
.
A. Submitter Information
Manufacturer:
Medos International Sárl Chemin-Blanc 38 2400 Le Locle, Switzerland
DePuy Spine, Inc. Submitter: 325 Paramount Drive Raynham, MA 02767
Contact Person:
Telephone number: Fax number: Email:
Kirsten Lehmuller 325 Paramount Drive Raynham, MA 02767 508-828-3291 508-828-3797 klehmull@its.jnj.com
July 25, 2013
AUG 2 2 2013
B. Date Prepared
C. Device Name
Trade/Proprietary Name: MOUNTAINEER® OCT Spinal System Common/Usual Name: Spinal System Spinal interlaminar fixation orthosis Classification Name: per 21 CFR §888.3050 Pedicle screw spinal system per 21 CFR §888.3070
D. Predicate Device Name
Trade name: MOUNTAINEER® OCT Spinal System (K041203, K042508, K080828, and K110353)
1
E. Device Description
The MOUNTAINEER® OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, lateral offset connectors, head-to-head connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws, monoaxial screws, hooks, and SONGER® Cables. The components are manufactured from Titanium Alloy.
The MOUNTAINEER® OCT Spinal System Longitudinal rods are also available in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537. Cobaltchromium-molybdenum alloy rods are intended for use with titanium components only.
F. Intended Use
The MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Atlanto/axial fracture with instability
- Occipitocervical dislocation
- Revision of previous cervical spine surgery
- · Tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The SONGER® wire/cable system to be used with the MOUNTAINEER® OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.
2
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM systems using the dual wedding band and axial connectors, and via dual diameter rods.
Summary of Similarities and Differences in Technological Characteristics, F. Performance and Intended Use
The proposed modifications to the MOUNTAINEER® OCT Spinal System is identical to the predicate devices (K041203, K042508, K080828, and K110353) except for the proposed devices will be terminally sterilized via gamma radiation. The design, materials, indications, and technology remain identical to the predicate systems.
G. Materials
Manufactured from ASTM F-136 implant grade titanium alloy and ASTM F-1537 cobalt-chromium-molybdenum alloy.
H. Performance Data
Performance data is not provided in this submission.
Conclusion l.
The Substantial Equivalence Justification demonstrates that the devices are as safe, as effective, and perform as well as the predicate devices.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Medos International Sárl % Ms. Kirsten Lehmuller DePuy Spine, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767
Re: K132332
Trade/Device Name: Mountaineer® OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: July 25, 2013 Received: July 26, 2013
Dear Ms. Lehmuller:
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 lound 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
4
Page 2 - Ms. Kirsten Lehmuller
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K132332
Device Name: MOUNTAINEER® OCT Spinal System Indications For Use:
The MOUNTAINEER OCT Spinal System is intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- · Spinal stenosis
- · Fracture/dislocation
- Atlanto/axial fracture with instability
- Occipitocervical dislocation
- · Revision of previous cervical spine surgery
- Tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The SONGER® wire/cable system to be used with the MOUNTAINEER OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA, MONARCH, MOSS MIAMI, VIPER and EXPEDIUM systems using the dual wedding band and axial connectors, and via dual diameter rods.
| Prescription Use | X |
|---|---|
| (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132332