The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft 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
Revision of previous cervical spine surgery
Tumors
Atlantoaxial fracture with instability
Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

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.

Device Description

The Caspian Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, rod connectors, and occipital components.

Materials: The devices are manufactured from Ti6Al4V (ASTM F1472), Ti6Al4V Eli (ASTM F136), and CP Titanium (ASTM F67).

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior cervical and thoracic spine.

AI/ML Overview

The Caspian Spinal System is a medical device intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction. The device's performance was evaluated through mechanical testing, with the acceptance criterion being that it performed "equally to or better than" predicate devices.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Performance in static compression	Performed equally to or better than predicate devices
Performance in static torsion	Performed equally to or better than predicate devices
Performance in dynamic compression	Performed equally to or better than predicate devices
Design features and sizing of components	Substantially the same as predicate devices

Study Details

Sample Size for Test Set: This information is not explicitly provided. The document states that the system was "mechanically tested," implying a set of samples were used for these tests, but the specific number is not given.
Data Provenance: Not applicable. The study involved mechanical testing of the device itself, not human data.
Number of Experts Used to Establish Ground Truth: Not applicable. Mechanical testing relies on established engineering standards (ASTM F2706) rather than expert consensus on individual cases.
Qualifications of Experts: Not applicable.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for diagnostic or image-interpretation devices involving human readers, which is not the case for a spinal fixation system.
Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.
Type of Ground Truth Used: The "ground truth" for this device's performance is defined by the established mechanical testing standards, specifically ASTM F2706, and the performance of legally marketed predicate devices. The system was deemed acceptable if its mechanical performance met or exceeded that of these established devices.
Sample Size for Training Set: Not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.
How Ground Truth for Training Set Was Established: Not applicable.

Summary

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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.

Submitter :

K2M, Inc. 751 Miller Drive SE. Suite F 1 Leesburg, VA 20175

Date Prepared: 09/01/10

Contact Person : Nancy Giezen K2M. Inc. Telephone: 703-777-3155

Tradename: Common Name: Classification Name: Device Product Code:

Regulatory Class:

Caspian Spinal System Spinal Fixation System Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) KWP Class II

OCT 4 2010

K101084

3. Predicate or legally marketed devices which are substantially equivalent :

K2M Caspian Spinal System (K081107) .
DePuy Summit (K002733) .
. Globus Protex (K050391)
. Synthes Synapse (K070573)
. Blackstone Ascent (030197)
Synthes Cervifix (K984377) .

4. Description of the device:

Materials: The devices are manufactured from Ti6Al4V (ASTM F1472), Ti6Al4V Eli (ASTM F136), and CP Titanium (ASTM F67).

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior cervical and thoracic spine.

5. Intended Use:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history . and radiographic studies)
. Spondvlolisthesis
. Spinal stenosis
Fracture/dislocation .
- Revision of previous cervical spine surgery
Tumors �

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Atlantoaxial fracture with instability
Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only.

The rod and hook components are intended for use in the cervical/upper thoracic (CI-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 rod connectors or transitional rods.

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :

The Caspian Spinal System was mechanically tested and compared to predicate devices. The Caspian Spinal System performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F2706. The design features and sizing of the components were also compared and the Caspian System was found to be substantially the same as these systems.

There are no significant differences between the Caspian Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

K2M, Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

OCT 4 2010

Re: K101084

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: September 20, 2010 Received: September 23, 2010

Dear Mr. 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. 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.

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

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Page 2 - Ms. Nancy Giezen

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 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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fa Vie

Dil Sie

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K101084

Device Name: Caspian Spinal System

Indications for Use:

. 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
. Atlantoaxial fracture with instability
Occipitocervical dislocation ●

The occipital bone screws are limited to occipital fixation only.

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 X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘ

(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical. Orthopedic, and Restorative Devices

KIOIO84 510(k) Number_

Regulation Number and Section

§ 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.