SPIDER SYSTEM KOLIBRI CEMENT NEEDLE

K130402 · Sintea Plustek, LLC · NDN · Apr 1, 2013 · Orthopedic

Device Facts

• Record ID: K130402
• Device Name: SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
• Applicant: Sintea Plustek, LLC
• Product Code: NDN · Orthopedic
• Decision Date: Apr 1, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

Device Story

Cannulated needle for spinal surgery; threaded proximal end for pedicle attachment; luer-lock for syringe/cement injection system connection; distal windows for cement outflow and distribution. Used by surgeons in clinical settings to create cavities in cancellous bone for vertebral augmentation. Facilitates delivery of FDA-cleared PMMA bone cement to treat compression fractures. Sterile, single-use device.

Clinical Evidence

No clinical data. Device evaluation based on functional testing and quality system requirements.

Technological Characteristics

Cannulated needle; threaded proximal end; luer-lock connector; distal outflow windows. Sterile supply. No specific material standards or software components described.

Indications for Use

Indicated for patients with pathological spinal compression fractures resulting from osteoporosis, benign lesions, or malignant lesions requiring cavity creation in cancellous bone for PMMA cement delivery.

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

• Sintea Spider System (K072198)
• Cardinal Health AVAflex Vertebral Augmentation Needle (K072133)
• Disc-O-Tech Confidence Bone Cement Needle (K063067)

Submission Summary (Full Text)

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K130402

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## 510(k) SUMMARY Sintea Plustek's Spider System KOLIBRI Cement Needle

Date:

January 18, 2012

APR 0 1 2013

Contact:

Guido Zorzoli 305-673-6226 Sintea Plustek 407 Lincoln Road Suite 10/L Miami, FL 33139

| Trade Name: | Spider System KOLIBRI Cement Needle |
|-----------------|-------------------------------------|
| Common Name: | Needle |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3027 |
| Product Code: | NDN, HXG |
| Panel Code: | 87 |
| | |

## Name of Device and Name/Address of Sponsor

Sintea Plustek, LLC 407 Lincoln Road Suite 10/L Miami, FL 33139 305-673-6226

#### Purpose:

The purpose of this submission is clearance of the Spider System KOLIBRI Cement Needle as an additional component to the Spider System (K072198).

#### Device Description

The needle has the following characteristics:

- . entirely cannulated needle;
- threaded proximal end to screw the needle into the pedicle to temporarily link the . needle to the pedicle during the cement injection; .
- . luer-lock to allow the easy connection with standard syringes and with other system of injection of the cement;
- . windows in the distal end that allow the outflow of cement and its optimal distribution around the needle.

The device is supplied in an appropriately labeled sterile packaging.

#### Predicate Device

The Spider System KOLIBRI Cement Needle is substantially equivalent to a legally marketed predicate device. The predicate device is the Sintea Spider System (K072198), Cardinal Health AVAflex Vertebral Augmentation Needle (K072133) and the Disc-O-Tech Confidence Bone Cement Needle (K063067).

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#### Intended Use / Indications for Use

The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

## Summary of Testing:

All materials used in fabrication of the Spider System KOLIBRI Cement Needle were evaluated through functional testing and appropriate quality system requirements. No mechanical testing is required.

## Summary:

The Spider System KOLIBRI Cement Needle is substantially equivalent to the predicate devices in regards to:

- . Indications for Use
- . Materials
- . Dimensions
- . Function

There are no significant differences in technological characteristics compared to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the left side of the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: April 1, 2013

Sintea Plustek % Mr. Guido Zorzoli President 407 Lincoln Road, Suite 10/L Miami, Florida 33139

Re: K130402

Trade/Device Name: Spider KOLIBRI Needle Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HXG Dated: March 5, 2013 Received: March 7, 2013

Dear Mr. Zorzoli:

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 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

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## Page 2 – Mr. Guido Zorzoli

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 [phone] or [phone] 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

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#### Indications for Use Statement

510(k) Number (if known): _ Device Name: Spider KOLIBRI Needle

Indications for Use:

The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.

Prescription Use _ V (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 Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130402