Mecta-C Stand Alone Extension

K203076 · Medacta International S.A. · OVE · Nov 6, 2020 · Orthopedic

Device Facts

• Record ID: K203076
• Device Name: Mecta-C Stand Alone Extension
• Applicant: Medacta International S.A.
• Product Code: OVE · Orthopedic
• Decision Date: Nov 6, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms for one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Mecta-C Stand Alone should be packed with autograft bone graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.

Device Story

Mecta-C Stand Alone is an anterior cervical interbody fusion system; consists of PEEK (uncoated or titanium-coated) cages, plates, and screws (locking, lag, and antibackout). Used by surgeons in clinical settings for cervical fusion; cages inserted between cervical vertebral bodies to provide support/correction; interior packed with autograft/allograft bone to promote fusion. Plates and screws provide fixation to vertebral bodies. Device is provided sterile for single-use. System aims to stabilize the spine and facilitate fusion in patients with DDD; output is mechanical stabilization of the spinal segment.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is based on identical technological characteristics to the predicate device (K192906) and bench testing performed for that predicate, including static/dynamic compression, torsion, subsidence, expulsion, pull-out, wear testing, and pyrogenicity.

Technological Characteristics

Materials: PEEK (uncoated or titanium-coated). Components: Cages, plates, locking/lag/antibackout screws. Fixed 7° lordosis. Standards: ASTM F2077-18 (static/dynamic compression, torsion), ASTM F2267-2018 (subsidence), ASTM F543-17 (pull-out, torque), ISO 17853:2011 (wear), USP <85>/<151> (pyrogenicity). Sterilization: Sterile, single-use.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one or two contiguous levels from C2-T1, following six weeks of failed non-operative treatment.

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

• Mecta-C Stand Alone (K192906)
• Coalition MIS with Screws Coalition AGX (K173115)

Submission Summary (Full Text)

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November 6, 2020

Medacta International SA Mr. Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K203076

Trade/Device Name: Mecta-C Stand Alone Extension Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 9, 2020 Received: October 13, 2020

Dear Mr. Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

### K203076

Device Name Mecta-C Stand Alone Extension

## Indications for Use (Describe)

The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms for one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Mecta-C Stand Alone should be packed with autograft bone graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

#### I. Submitter

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

Contact Person: Stefano Baj, Regulatory and Compliance Director. Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: October 9, 2020 Date Revised: October 29, 2020

#### II. Device

| Device Proprietary Name: | Mecta-C Stand Alone Extension |
|--------------------------|-----------------------------------|
| Common or Usual Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral body fusion device |
| Primary Product Code: | OVE |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification: | II |

#### III. Predicate Device

Primary predicate:

- Medacta International SA, Mecta-C Stand Alone, K192906 A
Additional predicate:

- A Globus Medical Inc., Coalition MIS with Screws Coalition AGX, K173115
#### Device Description IV.

The Mecta-C Stand Alone implants are the same of the predicate device, Mecta-C Stand Alone cleared within K192906.

They are provided sterile in single-use packages, designed for long-term implantation inside the human body and intended to be used during cervical interbody fusion surgeries.

The Mecta-C Stand Alone implants are composed of cages, plates, locking screws, lag screws and antibackout screws.

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The cages are to be inserted between two (2) cervical vertebral bodies to provide support and correction during cervical interbody fusion surgeries. They are made in PEEK uncoated or Titanium coated and they are available in various widths, heights, and lengths, with a fixed 7° of lordosis. The hollow geometry of the implants allows the cages to be packed with bone graft.

The plates, designed with different shapes to promote a specific approach or to simplify the procedure in a specific area, are assembled in front of the cage and allow for mounting of a certain number of screws. The screws are placed through the plate and cage in order to fix the device to the vertebral bodies.

#### V. Indications for Use

The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms for one level or two contiguous levels from C2- T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Mecta-C Stand Alone should be packed with autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.

#### VI. Comparison of Technological Characteristics

The subject Mecta-C Stand Alone is the same device of the predicate, Mecta-C Stand Alone cleared within K192906 with regards to the technological characteristics since they include exactly the same devices and the only difference is the indication for use.

The subject Mecta-C Stand Alone and the predicate devices (Coalition MIS with Screws Coalition AGX, K173115) share the following characteristics:

- indication for use; ●
- plate heights; ●
- materials;
- biocompatibility; ●
- device usage;
- sterility;
- shelf life; and ●
- packaging. ●

The subject Mecta-C Stand Alone differs from the predicate device (Coalition MIS with Screws Coalition AGX, K173115) with respect to:

- cage sizes;
- screw diameter;
- screw length;
- plate screw holes ●
- screw antibackout system; and

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- bone graft volume.
#### Performance Data VII.

The predicate Mecta-C Stand Alone (K192906) was tested using the worst case device for each one of the following tests:

- static compression per ASTM F2077-18;
- . static compression-shear per ASTM F2077-18;
- static torsion per ASTM F2077-18; ●
- static compression-shear without pockets ●
- subsidence per ASTM F2267-2018;
- expulsion:
- dynamic compression per ASTM F2077-18;
- dynamic compression-shear per ASTM F2077-18;
- dynamic torsion per ASTM F2077-18;
- dynamic compression-shear without pockets;
- plate removal;
- pull-out per ASTM F543-17;
- insertion and removal torque per ASTM F543-17; ●
- . torsion per ASTM F543-17;
- wear testing per ISO 17853:2011;
- implant imaging properties; and
- pyrogenicity test according to USP chapters <85> and <151> ●

The subject devices are the same of the predicate devices (K192906); therefore no additional testing are required.

No clinical studies were conducted for the predicate (K192906) nor for the subject devices.

## VIII. Conclusion

The subject device is the same of the predicate Mecta-C Stand Alone, K192906 with regards to technological characteristics. The only difference is the indication for use that is shared with the predicate Coalition MIS with Screws Coalition AGX, K173115.

Based on the comparison of technological characteristics, provided within this submission, and the performance data of the predicate devices, submitted and cleared within K192906, identical to the subject devices, the data supports the substantial equivalence of the subject Mecta-C Stand Alone with the predicate devices and thus the indication for use change object of this submission.