(30 days)
K2M Caspian Spinal System, DePuy Mountaineer, Biomet Altius
KWP, MNI
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "spinal fixation system" used to provide "stabilization as an adjunct to fusion" and "immobilization of spinal segments" for various spinal conditions, which are therapeutic actions.
No
The provided text describes the Caspian Spinal System as a fixation system used for stabilization and fusion in the spine, not for diagnosing medical conditions. It mentions "radiographic studies" as a basis for confirming disc degeneration, but the device itself is an implant, not a tool for performing these studies or making diagnoses.
No
The device description clearly outlines hardware components (pedicle screws, rods, locking set screws, hooks, rod connectors) made from specific materials (Ti6Al4V Eli and Cobalt Chrome). It is a physical spinal fixation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Caspian Spinal System Function: The Caspian Spinal System is a surgical implant designed to provide stabilization and aid in spinal fusion. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes the system's purpose as providing stabilization and acting as an adjunct to fusion for various spinal conditions. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the components (screws, rods, hooks, etc.) and materials of a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Caspian Spinal System is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Caspian Spinal System 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
- Revision of previous cervical spine surgery
- Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
Product codes
KWP, MNI
Device Description
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
Materials: The devices are manufactured from Ti6Al4V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical/upper thoracic (C1-T3) spine, T1-T3 in treating thoracic conditions only.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K2M Caspian Spinal System, DePuy Mountaineer, Biomet Altius
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 for the Caspian Spinal System
DEC 1 6 2009
This 510(k) summary for the Caspian Spinal System is provided as required per Section 513(i(i)(i) of the Food, Drug and Cosmetic Act.
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- Submitter : K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175
Contact Person : Nancy Giezen K2M, Inc.
- Submitter : K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175
751 Miller Drive SE, Suite F1 Leesburg, VA 20175 Telephone: 703-777-315 ذ
Date Prepared: 11/13/09
| 2. Tradename: | Caspian Spinal System |
|---|---|
| Common Name: | Spinal Fixation System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) |
| Device Product Code: | KWP |
| Regulatory Class: | Class II |
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- Predicate or legally marketed devices which are substantially equivalent :
- K2M Caspian Spinal System �
- . DePuy Mountaineer
- Biomet Altius .
4. Description of the device:
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
Materials: The devices are manufactured from Ti6Al4V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the cervical and thoracic (T1-T3) spine.
5. Intended Use:
The Caspian Spinal System 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
- . Revision of previous cervical spine surgery
- . Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
1
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- Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Caspian Spinal System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.
.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Caspian Spinal System is considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
K2M, Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive, SE, Suite F-1 Leesburg, Virginia 20175
DEC 1 6 2009
Re: K093534
Trade/Device Name: Caspian Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI Dated: November 13, 2009 Received: November 16, 2009
Dear Ms. Giezen:
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 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
3
Page 2 - Ms. Nancy Giezen
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jonita B
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K093534
Device Name: Caspian Spinal System
Indications For Use:
The Caspian Spinal System 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
- . Revision of previous cervical spine surgery
- . Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative ينان viets
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510(k) Number K093534