MECTALIF

K110927 · Medacta International · MAX · Jun 13, 2011 · Orthopedic

Device Facts

• Record ID: K110927
• Device Name: MECTALIF
• Applicant: Medacta International
• Product Code: MAX · Orthopedic
• Decision Date: Jun 13, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 is a family of PEEK intervertebral body fusion devices designed for lumbar spinal fusion. Implants are inserted during PLIF (Posterior Lumbar Intervertebral Fusion) or TLIF (Transforaminal Lumbar Intervertebral Fusion) procedures to replace a degenerative disc and restore spinal column height. Devices are used in conjunction with supplemental posterior fixation (e.g., pedicle screw systems) and autogenous bone graft. Implants feature Tantalum markers for radiographic visualization. Used by surgeons in an operating room setting. Benefits include stabilization of the spinal segment and facilitation of fusion in patients with discogenic pain.

Clinical Evidence

Bench testing only. Performance verified via mechanical testing including static compression, dynamic compression, dynamic compression/shear strength, and subsidence resistance according to ASTM F 2077 and ASTM F 2267 standards. No clinical data presented.

Technological Characteristics

Materials: Implant Grade Polyetheretherketone (PEEK) per ASTM F 2026; Tantalum markers per ISO 13782 / ASTM F 560. Form factor: Intervertebral spacers in various sizes for PLIF/TLIF. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 requiring interbody fusion. Includes patients with prior non-fusion spinal surgery. Requires 6 months of failed non-operative treatment. Contraindications: skeletal immaturity.

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

• Lumbar I/F Cage (P960025)
• Opal Spacer (K072791)
• Devex and Leopard Systems (K081917)
• Capstone Spinal System (K073291)
• Verte-Stack Boomerang (K040536)
• Clydesdale Spinal System (K100175)

Submission Summary (Full Text)

{0}------------------------------------------------

JUN 13 2011

Image /page/0/Picture/2 description: The image contains the word "Medacta" in a stylized font, with two black triangles above the first two letters. A horizontal line underlines the word. Below the line, the word "International" is printed in a smaller font. To the right of "International" is a square containing a plus sign.

# 510(k) Summary

- Manufacturer: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] FAX [phone]
- Contact Person: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: [phone] Fax: [phone] Email: [e-mail]

March 28, 2011 Date Prepared:

# DEVICE INFORMATION

Trade/Proprietary Name: MectaLIF 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: P960025 Lumbar I/F Cage K072791 Opal Spacer K081917 Devex and Leopard Systems K073291 Capstone Spinal System K040536 Verte-Stack Boomerang K100175 Clydesdale Spinal System

{1}------------------------------------------------

# Product Description:

The MectaLIF family is characterized by different sizes of PEEK (Polyetheretherketone) implants that can be applied with common surqical techniques such as PLIF (Posterior Lumbar Intervertebral Fusion) and TLIF (Transforaminal Lumbar Intervertebral Fusion). The MectaLIF family consists of the PEEK Oblique Interbody Fusion Device (33 sizes) and PEEK Posterior Interbody Fusion Device (28 sizes).

The PEEK Oblique and Posterior Interbody Fusion Devices are used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK and contain Tantalum Markers. 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 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.

# Comparison to Predicate Devices

The MectaLIF family is similar to the Depuv Acromed Lumbar I/F Cage, Synthes Opal Spacer (OPAL), Depuy Devex and Leopard Systems, and the Medtronic Capstone Spinal System (Capstone). All of these devices are intervertebral fusion devices with bone graft for the lumbar spine. They are all used for the same clinical condition or purpose, which is degenerative disc disease between L2 (2nd Lumbar Vertebrae) and S1 (1st Sacral Vertebrae). They are all indicated for use in combination with supplemental fixation as well as in combination with autogenous bone graft. The Lumbar I/F Cage, OPAL, and Capstone have a similar surgical procedure to the MectaLIF Posterior as all utilize the PLIF Posterior Lumbar Interbody Fusion (Posterior Approach). The OPAL, Capstone, Devex, and Leopard Systems have a similar surgical procedure to the MectaLIF Oblique as all utilize the TLIF Transforaminal Lumbar Interbody Fusion (Unilateral Approach). The MectaLIF Posterior and MectallF Oblique have similar geometrical features to the Lumbar I/F Cage, OPAL, and Capstone. The Lumbar I/F Cage and Devex System are similar to MectaLIF Posterior and Oblique implants in that all are offered with and without lordosis. The MectaLIF family uses similar materials in contact with the same tissue or body fluids as the OPAL, Capstone, and Verte-Stack Boomerang (Boomerang). The MectaLIF implants consist of Implant Grade Polyetheretherketone PEEK (ASTM F 2026), which is also used in the OPAL, Capstone, and Boomerang. The Tantalum (ISO 13782 / ASTM F 560) markers are also used in the Lumbar I/F Cage and the Boomerang system. The MectaLIF biomechanical features are similar to the OPAL, Devex, and Boomerang. The MectaLIF Posterior and Oblique implants have similar static compression strength to the Lumbar I/F Cage and Boomerang, similar dynamic compression strength to the OPAL and Boomerang,

{2}------------------------------------------------

similar dynamic compression/shear strength to the OPAL, and similar subsidence resistance to the Devex. The MectaLIF Oblique has a similar size range as the Medtronic Clydesdale Spinal System which has a maximum length of 40mm.

#### Performance Testing

Similar static compression strength - ASTM F 2077 Similar dynamic compression strength - ASTM F 2077 Similar dynamic compression/shear strength - ASTM F 2077 Similar subsidence resistance - ASTM F 2267

#### Conclusion:

Based on the above information, the MectaLIF implants can be considered as substantially equivalent to their predicate devices regarding clinical, technical, material and biomechanical aspects.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

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

JUN 1 3 2011

Re: K110927

Trade/Device Name: MectaLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 28, 2011 Received: April 01, 2011

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.

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.

{4}------------------------------------------------

Page 2 - Mr. Adam Gross

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin S. Keith

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

Enclosure

{5}------------------------------------------------

## Indications for Use Statement

# 510(k) Number (if known): K110927

Device Name: MectaLIF

#### 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.

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)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110927