K Number
K101084
Device Name
CASPIAN SPINAL SYSTEM
Manufacturer
Date Cleared
2010-10-04

(168 days)

Product Code
Regulation Number
888.3050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

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

Not Found

No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction for various medical conditions, indicating a therapeutic purpose.

No

The Caspian Spinal System is a spinal fixation system designed to provide stabilization and immobilization as an adjunct to fusion. It is a physical implant used for treatment, not for diagnosing conditions.

No

The device description explicitly states it is a "multiple component, posterior (occipital-cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, rod connectors, and occipital components," and lists the materials used for these physical components. This clearly indicates it is a hardware-based medical device.

Based on the provided text, 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 (like blood, urine, tissue) to provide information about a person's health.
  • Device Description: The Caspian Spinal System is described as a "top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system" consisting of screws, rods, hooks, etc. It is implanted into the body to provide stabilization.
  • Intended Use: The intended use is to "provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction." This is a surgical intervention, not a diagnostic test performed on a sample.

The description clearly indicates a surgically implanted device used for structural support and stabilization within the body, which is the opposite of an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

KWP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine, occipito-cervico-thoracic junction (occiput-T3), posterior cervical and thoracic spine, occipital, cervical/upper thoracic (C1-T3), 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)

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.

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.

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

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

§ 888.3050 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

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 F 1 Leesburg, VA 20175

Date Prepared: 09/01/10

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

  1. 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:

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.

5. Intended Use:

.

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)
  • . Spondvlolisthesis
  • . Spinal stenosis
  • Fracture/dislocation .
    • Revision of previous cervical spine surgery
  • Tumors �

1

  • 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.

2

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

3

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

4

Indications for Use

510(k) Number (if known): K101084

Device Name: Caspian Spinal System

Indications for Use:

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.

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_