MECTA-C

K112862 · Medacta International · ODP · Dec 19, 2011 · Orthopedic

Device Facts

• Record ID: K112862
• Device Name: MECTA-C
• Applicant: Medacta International
• Product Code: ODP · Orthopedic
• Decision Date: Dec 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation. The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

Device Story

Mecta-C is an intervertebral body fusion device for cervical spine stabilization. Device consists of PEEK body with tantalum markers for radiographic visualization; hollow geometry allows packing with autogenous bone graft. Used by surgeons in anterior cervical interbody fusion procedures; requires supplemental spinal fixation. Implants provided in various widths, heights, and lordotic angles to support vertebral bodies during fusion. Benefits include structural support and promotion of bone fusion in patients with degenerative cervical disc disease.

Clinical Evidence

Bench testing only. Performance testing included static and dynamic axial compression, static and dynamic compression/shear, static and dynamic torsion, and subsidence testing per ASTM F2077 and ASTM F2267 standards.

Technological Characteristics

PEEK (Polyetheretherketone) body with tantalum markers. Dimensions vary by width, height, and lordosis. Energy source: N/A (mechanical implant). Connectivity: N/A. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for anterior cervical interbody fusion in skeletally mature patients with cervical disc disease (neck pain of discogenic origin with disc degeneration) at one level from C2-T1, following six weeks of failed non-operative treatment. Must be used with autogenous bone graft and supplemental spinal 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

• Theken Spine Vu cPOD (K101363)
• Centerpulse Spine-Tech BAK-C (P980048)
• Depuy Spine Bengal Cage (K081917)
• Medacta MectaLIF (K110927)
• Aesculap CeSpace (K083311)
• Pioneer Intervertebral Body Fusion System (K073177)
• Titan Spine Endoskeleton TC (K100889)

Submission Summary (Full Text)

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K112862 Page // z

DEC 1 9 2011

Image /page/0/Picture/2 description: The image shows the logo for Medacta International. The logo consists of two triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is the word "International" in a smaller font, and to the right of the word "International" is a small square with a plus sign inside.

## 510(k) Summary

Medacta International SA Manufacturer: Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone [phone] FAX [phone]

- Mr. Adam Gross Contact Person: Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: [phone] Fax: [phone] Email: [e-mail]
Date Prepared: September 30. 2011

#### DEVICE INFORMATION

Trade/Proprietary Name: Mecta-C Common Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Body Fusion Device, Cervical

> 21 CFR 888.3080 Class II Device Product Codes: ODP

Predicate Devices: K101363 Theken Spine Vu cPOD P980048 Centerpulse Spine-Tech BAK-C K081917 Depuy Spine Bengal Cage K110927 Medacta MectaLIF K083311 Aesculap CeSpace K073177 Pioneer Intervertebral Body Fusion System K100889 - Titan Spine Endoskeleton TC

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## Product Description

The Mecta-C Intervertebral Body Fusion Devices are fusion devices intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical spine. The Mecta-C body fusion device is indicated for the treatment of degenerative diseases of the cervical disc and can be used for cervical fusion from C2-T1. The Mecta-C intervertebral body fusion devices consist of a PEEK (Polyetheretherketone) body and tantalum markers. The markers are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cages. The cages are offered in various widths, heights, footprint geometries and lordosis which can be inserted between two cervical vertebra bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

#### Indications for Use

The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

#### Comparison to Predicate Devices

The Mecta-C Intervertebral Body Fusion Device is substantially equivalent to K101363 Theken Spine Vu cPOD. P980048 Centerpulse Spine-Tech BAK-C. K083311 Aesculap CeSpace, K073177 Pioneer Intervertebral Body Fusion System, K100889 Titan Spine Endoskeleton TC, and K081917 Depuy Spine Bengal Cage in terms of indications for use, design, and function. Mecta-C is also substantially equivalent to K110927 Medacta MectaLIF, Vu crPOD and Bengal Cage in terms of materials. Mecta-C is substantially equivalent to MectaLIF in the manufacturing process. Performance testing has demonstrated that the Mecta-C Intervertebral Body Fusion Device is substantially equivalent in mechanical performance to the Vu cPOD and the Bengal Cage in Static and Dynamic Compression, Compression/Shear, Torsion, and Subsidence performance.

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### Performance Testing

Similar Static Axial Compression - ASTM F2077 Similar Dynamic Axial Compression - ASTM F2077 Similar Static Compression/Shear - ASTM F2077 Similar Dynamic Compression/Shear - ASTM F2077 Similar Static Torsion - ASTM F2077 Similar Dynamic Torsion - ASTM F2077 Similar Subsidence - ASTM F2267

Conclusion:

Based on the above information, the Mecta-C Intervertebral Body Fusion Device can be considered as substantially equivalent to its predicate devices in regards to indications, intended use, and technological features.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-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

DEC 1 9 2011

Re: K112862

Trade Name: Mecta-C Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 17, 2011 Received: November 18, 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.

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

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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For D.D. Moore

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

Enclosure

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# Indications for Use

510(k) Number (if known): K112862

Device Name: Mecta-C

Indications for Use:

The Mecta-C intervertebral body fusion device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation.

The Mecta-C device is intended for use at one level in the cervical spine, from C2-T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment prior to treatment with the device.

Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (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)

Divisio

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

510(k) Number_ K 112862

Mecta-C 510(k) November 14, 2011

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