MECTALIF

K131671 · Medacta International · MAX · Jul 5, 2013 · Orthopedic

Device Facts

• Record ID: K131671
• Device Name: MECTALIF
• Applicant: Medacta International
• Product Code: MAX · Orthopedic
• Decision Date: Jul 5, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

Device Story

MectaLIF Extension is an intervertebral body fusion device designed for spinal surgery. It features a bullet-nose tip geometry to provide self-distraction during insertion into the disc space. The device is implanted by a surgeon during spinal fusion procedures to stabilize the disc space in conjunction with supplemental posterior fixation (e.g., pedicle screw systems) and autogenous bone graft. It is intended to facilitate fusion in patients with degenerative disc disease. The device is a modification of existing MectaLIF systems, incorporating new sizes and the self-distracting tip. It is manufactured from PEEK-OPTIMA LT1, Tantalum, and Titanium alloy (Ti6Al4V ELI).

Clinical Evidence

Bench testing only. No clinical data provided. Performance was evaluated through engineering analysis and mechanical testing protocols based on ASTM standards (F2077, F2267) comparing the subject device to worst-case predicate configurations.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 (ASTM F 2026), Tantalum (ISO 13782 / ASTM F 560), and Titanium Ti6Al4V ELI (ISO 5832-3/ASTM F 136). Features: Bullet-nose tip geometry for self-distraction. Standards: ASTM F2077 (Static/Dynamic Axial Compression, Static/Dynamic Compression/Shear), ASTM F2267 (Subsidence Resistance).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels (L2-S1) requiring interbody fusion. DDD defined as discogenic pain with radiographic confirmation. Includes patients with prior non-fusion spinal surgery. Requires 6 months prior non-operative treatment. Used with autogenous bone graft and supplemental fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• MectaLIF Posterior and Oblique (K110927)
• MectaLIF Transforaminal (K120024)
• OPAL Spacer (K072791)
• Boomerang (K040536)
• Capstone (K073291)
• Devex/Leopard (K081917)
• Lumbar IF Cage (P960025)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two triangles, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is a dashed line, and below that is the word "International" in a smaller font. To the right of the word "Medacta" is a small square with a plus sign inside.

JUL 0 5 2013

# 510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] Fax [phone]

- Contact Person: Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: [phone] Fax: [phone] Email: [e-mail]
Date Prepared: June 7, 2013

## DEVICE INFORMATION

Trade/Proprietary Name: MectaLIF Extension Common Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar

> 21 CFR 888.3080 Class II Device Product Codes: MAX

## Predicate Devices:

| 510(k) | Product | 510(k) Holder | Clearance Date |
|---------|--------------------------------|-----------------------|----------------|
| K110927 | MectaLIF Posterior and Oblique | Medacta International | 6/13/2011 |
| K120024 | MectaLIF Transforaminal | Medacta International | 2/28/2012 |
| K072791 | OPAL Spacer | Synthes | 12/26/2007 |
| K040536 | Boomerang | Medtronic | 5/5/2004 |
| K073291 | Capstone | Medtronic | 04/24/2008 |
| K081917 | Devex/Leopard | Depuy Spine | 5/22/2009 |
| P960025 | Lumbar IF Cage | Depuy Acromed | 2/2/1999 |

MectaLIF Extension 510(k)

Section 5 - Page 2 of 4

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## Product Description

MectaLIF Extension is a design modification to MectaLIF Posterior and Oblique (K110927) and MectaLIF Transforaminal (K120024). The bullet nose modification to the implant tip geometry creates a self-distracting feature which facilitates insertion of the implant into the disc space. MectaLIF Extension also includes intermediate sizes of MectaLIF Posterior and Oblique as well as new sizes of MectaLIF Oblique. The materials and indications for use are identical to the predicate devices. The materials are PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) and Tantalum (ISO 13782 / ASTM F 560). MectaLIF Transforaminal also has a Gear made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The devices are intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft.

## Indications for Use

The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiquous spinal levels from L2 -- S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

## Comparison to Predicate Devices

The indications for use and materials of the MectaLIF Extension are identical to the previously cleared predicate devices. The design features, geometries, and sizes of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the MectaLIF Extension are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

## Performance Testing

The modification to the device system to include the addition of MectaLIF Extension was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The testing was conducted on the worst case component size and

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option/design based on engineering analysis. The MectaLIF Extension was compared to the worst case of the predicate devices and it was determined that the MectaLIF Extension are not worst case.

MectaLIF Extension has similar performance testing as the predicates in terms of: Static Axial Compression - ASTM F2077 Dynamic Axial Compression - ASTM F2077 Static Compression/Shear - ASTM F2077 Dynamic Compression/Shear - ASTM F2077 Subsidence Resistance - ASTM F2267

Conclusion:

Based on the above information, the MectaLIF Extension can be considered as substantially equivalent to its predicate devices.

Section 5 - Page 4 of 4

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an 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

Medacta International SA % Mr. Adam Gross Director of Regulatory, Quality and Compliance 4725 Calle Quetzal, Unit B Camarillo, California 93012

Re: K131671

Trade/Device Name: MectaLIF Extension Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 7, 2013 Received: June 7, 2013

Dear Mr. Gross:

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,

July 5, 2013

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

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## Page 2 - Mr. Adam Gross

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/dcfault.htm for the CDRH3'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 Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known): K131671

Device Name: MectaLIF Extension

Indications for Use:

The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Palients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

Prescription Use × (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

> Anton E. Dmitriev, PhD Division of Orthopedic Devices

MectaLIF Extension 510(k) June 6, 2013

Section 4 - Page 2 of 2