(141 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of the implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to treat degenerative disc disease, which falls under the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
This device is an interbody fusion device, specifically designed for treating degenerative disc disease by providing structural support and facilitating fusion between vertebrae. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly details physical components made of PEEK, titanium, and tantalum, including spacers, plates, and screws, which are implanted into the body. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The MectaLIF Anterior Stand Alone system is a surgical implant designed to be placed within the body (specifically, in the spine) to facilitate bone fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic testing.
Therefore, the MectaLIF Anterior Stand Alone system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MectaLIF Anterior Stand Alone system 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 Stand Alone 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 six months of non-operative treatment.
The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
Product codes
OVD
Device Description
The MectaLIF Anterior Stand-Alone is a stand-alone 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 Stand-Alone is intended to be used with bone screws provided and requires no additional supplementary fixation.
MectaLIF Anterior Stand-Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body. The spacer is available without any coatings and with a commercially pure titanium (CPTi, ASTM F 1580) coating. Both coated and uncoated spacers contain tantalum markers (ISO 13782 / ASTM F 560), and include 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 four different designs (Flush, Long, L5-S1, and Hybrid) 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, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.
The purpose of this submission is to alter the indications for use, and introduce new plate and screw designs.
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 following tests were conducted on the MectaLIF Anterior Stand-Alone in accordance with ASTM F2077, ASTM F2267, ASTM F1877, and ISO 17853:
- Static Axial Compression
- Dynamic Axial Compression
- Static Compression-Shear
- Dynamic Compression-Shear
- Static Torsion
- Dynamic Torsion
- Subsidence
- Expulsion
Key results: Based on the information presented above and within the submission, the MectaLIF Anterior Stand Alone is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K124034, K133192, K142744, K101310
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2016
Medacta International % Ms. Roshana Ahmed. RAC Mapi USA, Incorporated 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K160605
Trade/Device Name: MectaLIF Anterior Stand-Alone Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: June 15, 2016 Received: June 15, 2016
Dear Ms. Ahmed:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160605
Device Name MectaLIF Anterior Stand-Alone
Indications for Use (Describe)
The MectaLIF Anterior Stand Alone system 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 interior of the spacer component of the MectaLIF Anterior Stand Alone 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 six months of non-operative treatment.
The MectaLIF Anterior Stand-Alone system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in blue, with three blue triangles to the left of the word. There is a yellow line underneath the word "Medacta", and the word "International" is written in blue below the yellow line. To the right of the word "International" is a red square with a white cross in the center.
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 | |
| Contact Person: | Roshana Ahmed, M.A., RAC |
| Mapi USA, Inc. | |
| 2343 Alexandria Drive, Suite 100 | |
| Lexington, KY 40504 | |
| Sr. Manager, Regulatory Affairs | |
| Phone: 657-248-7361 |
Date Prepared: June 19, 2016
DEVICE INFORMATION
| Trade/Proprietary Name: | MectaLIF Anterior Stand-Alone |
|---|---|
| Common or Usual | |
| Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar |
| Product Code: | OVD |
| Regulation Number: | 888.3080 |
| Device Class: | 2 |
PREDICATE DEVICE INFORMATION
Primary Predicate:
MectaLIF Anterior, K124034, Medacta International SA
Additional Predicates:
MectaLIF TiPEEK, K133192, Medacta International SA Mecta-C TiPEEK, K142744, Medacta International SA Vu aPOD, K101310, Theken Spine
4
Image /page/4/Picture/0 description: The image shows the logo for Medacta International. The logo consists of two blue triangles on the left, followed by the name "Medacta" in blue. Underneath the name is a yellow line, and below that is the word "International" in gray. To the right of the word "International" is a red square with a white cross in the center.
DEVICE DESCRIPTION
The MectaLIF Anterior Stand-Alone is a stand-alone 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 Stand-Alone is intended to be used with bone screws provided and requires no additional supplementary fixation.
MectaLIF Anterior Stand-Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body. The spacer is available without any coatings and with a commercially pure titanium (CPTi, ASTM F 1580) coating. Both coated and uncoated spacers contain tantalum markers (ISO 13782 / ASTM F 560), and include 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 four different designs (Flush, Long, L5-S1, and Hybrid) 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, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.
The purpose of this submission is to alter the indications for use, and introduce new plate and screw designs.
INDICATIONS FOR USE
The MectaLIF Anterior Stand Alone system 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 Stand Alone 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 six months of non-operative treatment.
The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
5
Image /page/5/Picture/0 description: The image shows the logo for Medacta International. The logo consists of three blue triangles arranged in a row, followed by the word "Medacta" in blue. Below the triangles and the word is a yellow line, and below that is the word "International" in gray, followed by a red and white Swiss flag.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The MectaLIF Anterior Stand Alone is identical to the identified predicate devices in terms of cage size footprint, plate sizes, lordosis, screw plate interface, screw sizes, materials of construction, and sterilization method.
PERFORMANCE TESTING
The following tests were conducted on the MectaLIF Anterior Stand-Alone in accordance with ASTM F2077, ASTM F2267, ASTM F1877, and ISO 17853:
-
- Static Axial Compression
-
- Dynamic Axial Compression
-
- Static Compression-Shear
- Dynamic Compression-Shear 4.
- న. Static Torsion
-
- Dynamic Torsion
-
- Subsidence
-
- Expulsion
CONCLUSION:
Based on the information presented above and within the submission, the MectaLIF Anterior Stand Alone is substantially equivalent to the predicate devices.