(24 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an anterior cervical interbody fusion device implanted inside the human body to treat degenerative disc disease and provide support and correction during cervical interbody fusion surgeries, which definitively makes it a therapeutic device.
No
The device is an interbody fusion device, specifically an implant used for cervical interbody fusion surgeries, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is composed of physical implants (cages, plates, screws) made of PEEK or Titanium, designed for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states the Mecta-C Stand Alone is an implantable device used in surgery to fuse vertebrae. It is not used to test blood, tissue, or other bodily fluids.
- The intended use is for surgical implantation. The device is designed to be placed inside the body to provide structural support and promote bone fusion. This is a therapeutic intervention, not a diagnostic test.
- The device description focuses on materials, design, and surgical application. There is no mention of reagents, assays, or any components typically associated with in vitro testing.
Therefore, the Mecta-C Stand Alone is a surgical implant, not an IVD.
N/A
Intended Use / 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 graft composed of cancellous, cortical and/or corticocancellous bone graft and implanted via an anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2-T1
Indicated Patient Age Range
skeletally mature patients
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 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 and ●
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
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.
4
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
5
- 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 and ●
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.