(93 days)
No
The summary describes a mechanical interbody fusion device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an interbody fusion device indicated for use in patients with degenerative disc disease, aiming to treat a medical condition.
No
This device is an interbody fusion device, specifically a surgical implant used for treating degenerative disc disease, not for diagnosing it. The text describes its use for treatment and fixation, not for generating diagnostic information.
No
The device description explicitly states it consists of "cages, plates and screws," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as a system of cages, plates, and screws made of titanium, designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
The MectaLIF Anterior is an 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. These patients should be skeletally mature and have had at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.
Product codes
OVD
Device Description
MectaLIF Anterior Stand Alone Fusion Device System, consisting of cages, plates and screws, does not require additional fixation. The MectaLIF Anterior cage can be coupled with four different profiles of stand-alone plates: flush, long, L5-S1 and hybrid.
The purpose of this submission is to gain the clearance for a design change performed on the MectaLIF Anterior lag plates flush and their related cover plate already cleared within K221545.
The lag plate flush is secured to the disc spacer via an interlocking mechanism and an additional antiback-out cover plate, used to reduce the risk of screw migration after the implantation.
No materials' changes have been performed, thus both the plates and the screws are made of Ti6Al4V ELI (ISO 5832-3/ASTM F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (Spine)
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)
Non-Clinical Studies:
- PERFORMANCE TESTING
- Simulated-use testing to confirm that, during operation according to the surgical technique, the device can achieve its intended use.
- Simulated-use testing to confirm that, in case of potential misuse generated by fastening attempt with the Cover Plate off axis, the device can achieve its intended use.
- Resistance testing to confirm that the resistance of the Flush Plate-Cover Plate interface is above the required strength.
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2023
Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive, Suite 101 Memphis. Tennessee 38141
Re: K232123
Trade/Device Name: MectaLIF Anterior Lag Extension Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: July 17, 2023 Received: August 3, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
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
Submission Number (if known)
Device Name
MectaLIF Anterior Lag Extension
Indications for Use (Describe)
The MectaLIF Anterior is an 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.
These patients should be skeletally mature and have had at least six months of non-operative treatment.
These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.
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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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, Senior Director, Quality, Regulatory, and Clinical Research, Medacta USA
Date Prepared: July 17, 2023
II. Device
| Device Proprietary Name: | MectaLIF Anterior Lag Extension |
|---|---|
| Common or Usual Name: | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Classification Name: | Intervertebral body fusion device |
| Primary Product Code | OVD |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification | II |
Predicate Device III.
Substantial equivalence is claimed to the following primary predicate device:
- A MectaLIF Anterior Extension, K221545, Medacta International SA.
IV. Device Description
MectaLIF Anterior Stand Alone Fusion Device System, consisting of cages, plates and screws, does not require additional fixation. The MectaLIF Anterior cage can be coupled with four different profiles of stand-alone plates: flush, long, L5-S1 and hybrid.
The purpose of this submission is to gain the clearance for a design change performed on the MectaLIF Anterior lag plates flush and their related cover plate already cleared within K221545.
The lag plate flush is secured to the disc spacer via an interlocking mechanism and an additional antiback-out cover plate, used to reduce the risk of screw migration after the implantation.
No materials' changes have been performed, thus both the plates and the screws are made of Ti6Al4V ELI (ISO 5832-3/ASTM F136).
4
V. Indications for Use
The MectaLIF Anterior is an 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. These patients should be skeletally mature and have had at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.
VI. Comparison of Technological Characteristics
The subject MectaLIF Anterior Lag Extension implants are identical to the predicate devices with regards to the following characteristics:
- Indications for use;
- System's device components; ●
- General design: ●
- Material:
- Biocompatibility: ●
- . Device usage:
- . Sterility:
- Shelf-life; and
- Packaging. ●
The only differences between the subject and the predicate devices are related to the design changes implemented on the sub-components of lag plates flush and cover plate.
Discussion
The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness as demonstrated by the risk analysis provided within the submission.
Medacta International SA has not made any change to the indications for use, manufacturing process, material, device usage, biocompatibility, sterility, shelf life and packaging of the subject devices with respect to the predicate devices.
The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices respect to the predicate devices.
VII. Performance Data
Based on the risk analysis, testing activities were conducted to written protocols. The following validations and tests support the substantial equivalence determination:
Non-Clinical Studies
5
- PERFORMANCE TESTING ●
- Simulated-use testing to confirm that, during operation according to the surgical O technique, the device can achieve its intended use.
- Simulated-use testing to confirm that, in case of potential misuse generated by fastening о attempt with the Cover Plate off axis, the device can achieve its intended use.
- Resistance testing to confirm that the resistance of the Flush Plate-Cover Plate interface o is above the required strength.
- PYROGENICITY ●
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which o is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination o
- The subject devices are not labeled as non-pyrogenic or pyrogen free. O
- BIOCOMPATIBILITY evaluation ●
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the subject devices are substantially equivalent to the predicate devices.