(175 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for conditions such as DDD, Spondylolisthesis, and fractures, and functions to provide stabilization and immobilization of spinal segments, which are therapeutic actions.
No
The device is described as a spinal fixation system that functions as an adjunct to fusion to provide immobilization of spinal segments. It is used to treat conditions like DDD, spondylolisthesis, and spinal stenosis, not diagnose them.
No
The device description explicitly lists physical components such as pedicle screws, rods, locking set screws, hooks, and rod connectors, and describes their material and function as a spinal fixation system.
No, 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.
- Device Description: The Caspian Spinal System is a physical implantable device (screws, rods, hooks) used to stabilize the spine during fusion surgery. It is a surgical implant, not a diagnostic test performed on a sample.
- Intended Use: The intended use describes the conditions the device is used to treat (DDD, spondylolisthesis, etc.) and its function as an adjunct to fusion for stabilization. This is a therapeutic and structural function, not a diagnostic one.
Therefore, based on the provided information, the Caspian Spinal System is a surgical implant and not an In Vitro Diagnostic device.
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
Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
Product codes
KWP
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 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, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Starlock/ Cervifix, Interpore Mini VLS/ Altius, DePuy Mountaineer, Spinal Concepts Octafix
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.
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OCT 1 0 2008
510(k) Summary for the Caspian Spinal System
This 510(k) summary for the Caspian System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
1. Submitter : K2M, Inc. 751 Miller Drive SE, Suite F1 Leesburg, VA 20175
Date Prepared: 10/10/08
Contact Person :
Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite Fl Leesburg, VA 20175 Telephone: 703-777-3155
| 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 |
3. Predicate or legally marketed devices which are substantially equivalent :
- . Synthes Starlock/ Cervifix
- . Interpore Mini VLS/ Altius
- . DePuy Mountaineer
- . Spinal Concepts Octafix
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 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 ● patient history and radiographic studies)
- � Spondylolisthesis
- Spinal stenosis .
- Fracture/dislocation .
- . Revision of previous cervical spine surgery
- Tumors ●
Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
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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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2008
K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175
Re: K081107 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 Dated: October 09, 2008 Received: October 10, 2008
Dear Mr. Woods:
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.
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Page 2 - Mr. Richard W. Woods
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 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 N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string appears to be a combination of letters and numbers, specifically 'K081107'. The characters are written in a simple, slightly irregular style, suggesting they were written quickly or without much precision. The handwriting is clear enough to be legible.
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Indications for Use
510(k) Number (if known):
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
Hooks and Rods-The rod and hook components are also intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods and Pedicle Screws-The rods and screws are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following reduction of fracture/dislocation or trauma in the upper thoracic spine (T1-T3). The use of these screws is limited to placement in T1-T3 in treating theracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
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 OF NEEDED)
Concurrence of CDRH, Office of Device B
,
Mark A. Mckinnon
Division Sign-Off) vision of General. Bestorative. and Neurological Devices
Si3(E) Number
KO81/07