K Number

Device Name

MECTALIF ANTERIOR

Manufacturer

MEDACTA INTERNATIONAL

Date Cleared

2013-05-17

(140 days)

Product Code

OVD

Regulation Number

888.3080

Intended Use

The MectaLIF Anterior is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior can be packed with autograft or autologous bone graft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The MectaLIF Anterior is a system intended to be used with the integrated bone screws provided and requires additional supplementary fixation such as pedicle screws and rods. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should be skeletally mature and have had six months of non-operative treatment.

Device Description

The MectaLIF Anterior is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior is intended to be used with bone screws provided and requires additional supplementary fixation. MectaLIF Anterior consists of a disc spacer made of PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) which contains three Tantalum Markers (ISO 13782 / ASTM F 560), bone screws made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and a plate made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in three different designs (Flush, Long, and L5-S1) and is secured to the disc spacer via an interlocking mechanism. The disc spacer and attached plate are secured to the vertebral body with the bone screws. The Flush and Long plates are used with four bone screws while the L5-S1 plate is used with three bone screws.

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

K101310, K073109, K101301, K110927, K072253, K022791, K071726, K082252, K013665

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical interbody fusion device made of PEEK and Titanium, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is an interbody fusion device for patients with degenerative disc disease, which is designed to treat and alleviate symptoms associated with this condition, fitting the definition of a therapeutic device.

Diagnostic

The MectaLIF Anterior is an interbody fusion device intended for the treatment of degenerative disc disease, not for diagnosing it. The device description and intended use clearly state its function as an implant used in surgical procedures.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components made of PEEK, Tantalum, and Titanium, which are hardware materials. The device is an anterior interbody fusion device, which is a physical implant.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Description and Intended Use: The MectaLIF Anterior is a physical implant designed for surgical use in the spine. It is a fusion device intended to provide structural support and promote bone growth between vertebrae.
Lack of Diagnostic Function: The description focuses on the device's mechanical properties, materials, and surgical application. There is no mention of it analyzing biological samples or providing diagnostic information.

Therefore, the MectaLIF Anterior falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The MectaLIF Anterior is a system intended to be used with the integrated bone screws provided and requires additional supplementary fixation such as pedicle screws and rods.

These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These patients should be skeletally mature and have had six months of non-operative treatment.

Product codes

OVD

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

L2 to S1

Indicated Patient Age Range

skeletally mature

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The MectaLIF Anterior was tested per ASTM F2077 and ASTM F2267 using the worstcase device for each of the following tests:

1. Static Axial Compression
1. Dynamic Axial Compression
1. Static Compression-Shear
1. Dynamic Compression-Shear
1. Static Torsion
1. Dynamic Torsion
1. Subsidence
1. Expulsion

The performance testing demonstrated that the MectaLIF Anterior is not worst case compared to predicate data.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101310, K073109, K101301, K110927, K072253, K022791, K071726, K082252, K013665

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.

Summary

Image /page/0/Picture/0 description: The image shows the logo for Medacta International. The logo consists of two black triangles, the word "Medacta" in black, a black line underneath the word, the word "International" in black, and a black plus sign. The logo is simple and modern.

K124034 Page 1 of 3

MAY 1 7 2013

510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Mr. Adam Gross Contact Person: Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com

December 14, 2012 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name: MectaLIF Anterior Common Name: Anterior Intervertebral Body Fusion Device Classification Name: intervertebral fusion device with integrated fixation, lumbar

21 CFR 888.3080 Class II Device Product Codes: OVD

Predicate Devices:

K101310 Vu aPOD, Integra Spine K073109 Stalif TT, Centinel Spine K101301 Stalif Midline, Centinel Spine K110927 MectaLIF, Medacta International K072253 SynFix-LR, Synthes K022791 ATB System, Synthes K071726 Zuma, SeaSpine K082252 Independence, Globus Medical K013665 Pyramid plate, Medtronic

MectaLIF Anterior 510(k)

Section 5 - Page 2 of 4

Product Description

Indications for Use

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The MectaLIF Anterior is a system intended to be used with the integrated bone screws provided and requires additional supplementary fixation such as pedicle screws and rods.

These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These patients should be skeletally mature and have had six months of non-operative treatment.

Comparison to Predicate Devices

The indications for use, design features and materials of the MectaLIF Anterior 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 Anterior are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

K124034 Page 3 of 3

Performance Testing

The MectaLIF Anterior was tested per ASTM F2077 and ASTM F2267 using the worstcase device for each of the following tests:

1. Static Axial Compression
1. Dynamic Axial Compression
1. Static Compression-Shear
1. Dynamic Compression-Shear
1. Static Torsion
1. Dynamic Torsion
1. Subsidence
1. Expulsion

The performance testing demonstrated that the MectaLIF Anterior is not worst case compared to predicate data.

Conclusion:

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

MectaLIF Anterior 510(k)

Image /page/3/Picture/0 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 figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Letter dated: May 17, 2013

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

Re: K124034

Trade/Device Name: MectaLIF Anterior Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: April 11, 2013 Received: April 15, 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.

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

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 (800) 638-2041 or (301) 796-7100 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark Night erson -S

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

Enclosure

K124034 Page 1 of 1

Indications for Use

510(k) Number: K124034

Device Name: MectaLIF Anterior

Indications for Use:

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The MectaLIF Anterior is a system intended to be used with the integrated bone screws provided and requires additional supplementary fixation such as pedicle screws and rods.

These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These patients should be skeletally mature and have had six months of non-operative treatment.

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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K124034

MectaLIF Anterior 510(k) April 11, 2013