K Number

Device Name

CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G

Manufacturer

MEDOS INTERNATIONAL SARL

Date Cleared

2011-12-22

(80 days)

Product Code

NDN

Regulation Number

888.3027

Intended Use

CONFIDENCE High Viscosity Spinal Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), or malignant lesions (metastatic cancers, myeloma).

Device Description

CONFIDENCE High Viscosity Spinal Cement is self-curing, radiopaque, polymethyl methacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilisation of the vertebral body and pain relief.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K060300, K071927

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a traditional PMMA bone cement and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is indicated for the "fixation of pathological fractures of the vertebral body" and is described as providing "stabilisation of the vertebral body and pain relief" for conditions like osteoporotic fractures and lesions. These are therapeutic interventions.

Diagnostic

No
The device is a spinal cement used for fixation of fractures, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a polymethyl methacrylate (PMMA) cement, which is a physical material, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
Device Function: The CONFIDENCE High Viscosity Spinal Cement is a material that is implanted into the body to stabilize fractured vertebrae. It is a therapeutic device, not a diagnostic one.
Intended Use: The intended use clearly states it's for the "fixation of pathological fractures" and "stabilisation of the vertebral body and pain relief." This is a treatment, not a diagnostic process.
Device Description: The description details the composition and function of the cement as a filling material, not a test or analysis of a biological sample.

Therefore, based on the provided information, the CONFIDENCE High Viscosity Spinal Cement is a medical device used for treatment, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

NDN

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vertebral body

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)

K060300, K071927

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
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.(b)
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.”

Summary

i12907

510(k) Summary

DEC 2 2 2011

Date Summary Prepared:	30 September 2011
------------------------	-------------------

510(k) Sponsor: Medos International SARL Chemin-Blanc 38 Le Locle CH 2400 Switzerland

Establishment Registration number: 3008114965

Contact Person:

Robin DiNardo Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham MA 02767-0350 USA

Telephone: +1 508 828 3218 Fax: +1 508 828 3797 Email: rdinardo@its.jnj.com

Device Manufacturer: Medos International SARL Chemin-Blanc 38 Le Locle CH 2400 Switzerland

Trade Name of Device: CONFIDENCE High Viscosity Spinal Cement

Part Numbers: 183907001 (16 g Unit Size)

183901001 (20 g Unit Size)

Product Code: NDN

Cement, bone, vertebroplasty

Common Name: PMMA Bone Cement

Classification Name:

Equivalent to:

Disc-O-Tech Confidence High Viscosity Spinal Cement (K060300) DePuy Spine Vertebroplastic™ Radiopaque Bone Cement (K071927)

Device Description:

Indications for Use:

Contra-indications for Use:

The use of CONFIDENCE High Viscosity Spinal Cement is contraindicated in patients presenting with any of the following conditions:

Non-pathological, acute, traumatic fractures of the vertebra. .
. Patient clearly improving on medical therapy.
Prophylaxis in metastatic or osteoporotic patients with no evidence of acute fracture .
Spinal stenosis (> 20% by retropulsed fragments). .
. Compromise of the vertebral body or walls of the pedicles.
. Compromise or instability of vertebral fractures due to posterior involvement.
. Haemorrhagic diathesis.
. Anatomical damage of the vertebra that prevents a safe access of the needle to the vertebral body.
. Vertebral body collapse to less than 1/3 (33%) original height.
Vertebral plana (collapse >90%). .
Active or incompletely treated infection. .
Coagulopathy or inability to reverse anti-coagulant therapy (both during and . approximately 24 hours post-procedure).
. Severe pulmonary insufficiency.
. Sensitivity to any of the components of the CONFIDENCE High Viscosity Spinal Cement.

Basis for Substantial Equivalence:

The Medos International SARL CONFIDENCE High Viscosity Spinal Cement has identical intended use and indications for use to the predicate devices Disc-O-Tech Confidence High Viscosity Spinal Cement (K060300) and DePuy Spine Inc Vertebroplastic " Radiopaque Bone Cement (K071927).

The packaging of the subject device is equivalent to the predicate device Disc-O-Tech Confidence High Viscosity Spinal Cement (K060300), and the manufacturing and sterilization methods are the same as both predicate devices. Chemical composition of the Medos International SARL CONFIDENCE High Viscosity Spinal Cement is similar to

subject devices, and testing has confirmed the devices to have comparable performance characteristics.

Based on the similarities in indications, intended use, design, materials, method of manufacture and the results of performance testing, Medos International SARL believes that the subject device CONFIDENCE High Viscosity Spinal Cement is substantially equivalent to the previously cleared devices.

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

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

DEC 2 2 2011

Medos International SARL % DePuy Spine, Inc. Ms. Robin DiNardo 325 Paramount Drive Raynham, Massachusetts 02767

Re: K112907

Trade/Device Name: CONFIDENCE High Viscosity Spinal Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: September 30, 2011 Received: October 03, 2011

Dear Ms. DiNardo:

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

Page 2 - Ms. Robin DiNardo

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. McMullen

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

Enclosure

Indications for Use

Device Name:

CONFIDENCE High Viscosity Spinal Cement

Indications for Use:

Prescription Use YES (Part 21 CFR 801 Subpart D)

Over-The-Counter Use NO AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Offige of Device Evaluation (ODE)

signature

(DKIslon Sigilia :1) (Division Sign=on Surgical, Orthopedic, and Restorative Devices

510(k) Number K112907

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