HIGH V+

K161114 · Teknimed Sas · NDN · Apr 12, 2017 · Orthopedic

Device Facts

• Record ID: K161114
• Device Name: HIGH V+
• Applicant: Teknimed Sas
• Product Code: NDN · Orthopedic
• Decision Date: Apr 12, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HIGH V+ is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Device Story

HIGH V+ is a self-hardening, radiopaque PMMA bone cement; used for stabilization of fractured vertebral bodies via vertebroplasty or kyphoplasty procedures. Device consists of two sterile components: powder (PMMA, hydroxyapatite, barium sulfate, benzoyl peroxide) and liquid monomer (methyl methacrylate). Components mixed intraoperatively; injected into vertebral body to provide consolidation and pain relief. Used in clinical settings by physicians; provides structural stabilization of fractures. Benefits include rapid pain relief and vertebral body consolidation.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including powder morphology, molecular weight, monomer elution, viscosity, setting time, handling times, compressive/bending strength, bending modulus, dynamic fatigue, radiopacity, glass transition, and bacterial endotoxin testing.

Technological Characteristics

PMMA bone cement; powder (PMMA, hydroxyapatite, barium sulfate, benzoyl peroxide) and liquid (methyl methacrylate, dimethyl-paratoluidine, hydroquinone). Complies with ISO 5833. Sterilization: Gamma radiation (powder), filtration (liquid), ethylene oxide (blister).

Indications for Use

Indicated for fixation of pathological vertebral body fractures in patients with painful vertebral compression fractures due to osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

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

• Vertecem (K090435)
• Spineplex (K032945)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, with flowing lines beneath them.

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

April 12, 2017

Teknimed, SAS % Mr. J.D. Webb Authorized Contact Person The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock. Texas 78681

Re: K161114

Trade/Device Name: HIGH V+ Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: April 10, 2017 Received: April 11, 2017

Dear Mr. Webb:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Vincent J. Devlin -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K161114

Device Name

HIGH V+

Indications for Use (Describe)

The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

।

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#### 510(k) Summary for the HIGH V+ Bone cement

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the HIGH V+.

#### 1. GENERAL INFORMATION

| Date Prepared: | November 11, 2016 |
|----------------|-------------------|
|----------------|-------------------|

Trade Name: HIGH V+

Common Name: Polymethylmethacrylate (PMMA) bone cement

Classification Name: Cement, Bone, Vertebroplasty

Class: II

Product Code: NDN

CFR section: 21 CFR section 888.3027

Device panel: Orthopedic

PrimaryLegally Vertecem, K090435 Marketed Predicate Device:

Secondary Legally Spineplex K032945 Marketed Predicate Device:

- Submitter: Teknimed, SAS 11, rue d'Apollo 31240 L'Union France
- Contact: J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Tele 512-692-3699 Fax e-mail: [e-mail]

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#### 2. DEVICE DESCRIPTION

HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.

#### Material:

The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA), hydroxyapatite and barium sulfate.Benzoyl peroxide which initiates the polymerization is included in the polymer powder.

#### Function:

The HIGH V+ bone cement allows stabilization of the vertebral body and a rapid pain relief.

#### 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

HIGH V+ has similar technological characteristics as the predicate devices as shown in the detailed side by side comparison in the following table.

| Device<br>Items | HIGH V+ | Vertecem | Spineplex |
|-------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------|
| Sponsor | Teknimed | Teknimed | Stryker |
| 510(k) Number | -- | K090435 | K032945 |
| Product Code | NDN | NDN | NDN |
| Indications for Use | [2] below table | [1] below table | [3] below table |
| Chemical composition | | | |
| Powder (% w/w) | 20g ± 0.4g | 21g ± 0.4g | 20g |
| Polymethymethacrylate | 63.1% ± 1% | 43.4% ± 1% | 11.5% |
| Methyl methacrylate<br>styrene copolymer | -- | 16.1% ± 1% | 57% |
| Benzoyl peroxide | 0.5% ± 0.1% | 0.5% ± 0.1% | 1.5% |
| Barium sulfate | 27.3% +2.1% - 1.9% | 30% +2% -3% | 30% |
| Hydroxyapatite | 9.1% +1.9% / -2.1% | 10% ± 1% | -- |
| Liquid (% w/w) | 8.6g ± 0.2g | 9.2 ± 0.2g | 9.4g |
| Methylmethacrylate | 98.5% ± 1% | 99.3% ± 1% | 97.4% |
| Device<br>Items | HIGH V+ | Vertecem | Spineplex |
| Dimethyl-paratoluidine | 1.5% ± 0.1% | 0.7% ± 0.1% | 2.6% |
| Hydroquinone | 20ppm± 5ppm | 20ppm± 5ppm | 75ppm |
| Physical<br>characteristics | | | |
| Molecular weights:<br>Powder | 534,511 g/mole | 222,518 g/mole | -- |
| Cured cement | 646,966 g/mole | 394 552 g/mole | |
| Working phases @ 20°C | Mixing: 0.5 min<br>• Waiting: 3 min<br>• Application: 9 min<br>• Setting time: 16min | Mixing: 3 min<br>• Waiting: 11.5 min<br>• Application: 25 min<br>• Setting time: 30min | |
| Compressive strength | 81.91 MPa | 80.3 MPa | -- |
| Dynamic tension-<br>compression mean<br>fatigue | 4,627,970±847,458<br>cycles @ 7Mpa | 4,317,676±1,237,780<br>cycles @ 7Mpa | 3,799,425±1,990,989<br>cycles @ 7Mpa |
| Bending strength | 57.22 MPa | 52.6 MPa | -- |
| Bending modulus | 3338.82 | 4173 MPa | -- |
| Radiopacity | Equivalent radiopacity | Equivalent radiopacity | Equivalent radiopacity |
| Monomer elution testing | Increase release till<br>10 minutes after<br>mixing, then<br>stabilization | Increase release till<br>10 minutes after<br>mixing, then<br>stabilization | -- |
| Sterilization method | | | |
| Powder | Gamma radiation<br>(ISO 11137) | Gamma radiation<br>(ISO 11137) | Gamma radiation<br>(ISO 11137) |
| Liquid | Filtration (ISO 13408) | Filtration (ISO 13408) | Filtration (ISO 13408) |
| Inner Blister | Ethylene oxide (ISO<br>11135-1) | Ethylene oxide (ISO<br>11135-1) | Ethylene oxide (ISO<br>11135-1) |

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#### 4. INTENDED USE

The HIGH V+ is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

#### 5. NON-CLINICAL TEST SUMMARY

The following tests were conducted:

- · Powder morphology
- · Molecular weights
- . Monomer elution testing
- . Viscosity vs. temperature
- . Setting time vs. temperature
- Handling times .
- . Compressive strength
- Bending strength .
- Bending modulus .
- Dynamic tension-compression fatigue test .
- · Radiopacity
- Glass transition .
- Bacterial Endotoxins Test (BET) to establish non-pyrogenicity .

Test data indicate that the final properties of HIGH V+ are in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are substantially equivalent to those of predicate devices.

#### 6. CLINICAL TEST SUMMARY

No clinical studies were performed.

#### 7. CONCLUSIONS NONCLINICAL AND CLINICAL

This summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that HGH V+ bone cement is as safe, as effective, and perform as well as the predicate devices.