(56 days)
Not Found
No
The device description focuses on the physical characteristics, materials, and mechanical function of a spinal implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to replace a degenerative disc and restore spinal column height in patients with degenerative disc disease, which constitutes a therapeutic intervention.
No
The device is an implantable intervertebral body fusion device used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical implant made of PEEK, Titanium, and Tantalum, and includes mechanical components like a gear. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The MectaLIF implants are described as physical implants made of PEEK, Titanium, and Tantalum, intended for surgical implantation into the spine to replace a degenerative disc and facilitate spinal fusion.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from the patient. Its function is purely mechanical and structural within the body.
Therefore, the MectaLIF Transforaminal device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
MectaLIF Transforaminal lumbar intervertebral body fusion device is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). Mectal IF Transforaminal is used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK-OPTIMA LT1 and contain Tantalum Markers as well as a titanium gear which enables the surgeon to alter the angle of the MectaLIF Transforaminal in situ in 15° increments and to reposition during surgery without switching instrumentation. MectaLIF Transforaminal is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The dimensions of MectaLIF Transforaminal are within the following range: Length 30-34mm; Height 8-15mm; Width 12-14mm; Lordosis 5°. The materials of the components of MectaLIF Transforaminal are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026), Gear: Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and Marker: Tantalum (ISO 13782 / ASTM F 560).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal levels L2 – S1
Indicated Patient Age Range
Patients must be 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)
MectaLIF Transforaminal has similar performance testing as the predicates in terms of:
Static Axial Compression - ASTM F2077
Dynamic Axial Compression - ASTM F2077
Static Compression/Shear - ASTM F2077
Dynamic Compression/Shear - ASTM F2077
Subsidence Resistance - ASTM F2267
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.
K110927 MectaLIF Oblique (Medacta Intl), K040536 Verte-Stack Boomerang (Medtronic), K072791 OPAL Spacer (Synthes), K081888 Dynamik (Spineart), K081917 Devex/Leopard (Depuy Spine), P960025 Lumbar IF Cage (Depuy Acromed), K103034 Apache TLIF (Genesys Spine)
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
FEB 2 8 2012
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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: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com
Date Prepared: December 30, 2011
DEVICE INFORMATION
Trade/Proprietary Name: MectaLIF Transforaminal Common Name: Intervertebral Body Fusion Device Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar
21 CFR 888.3080 Class II Device Product Codes: MAX
Predicate Devices: K110927 MectaLIF Oblique (Medacta Intl) K040536 Verte-Stack Boomerang (Medtronic) K072791 OPAL Spacer (Synthes) K081888 Dynamik (Spineart) K081917 Devex/Leopard (Depuy Spine) P960025 Lumbar IF Cage (Depuy Acromed) K103034 Apache TLIF (Genesys Spine)
MectaLIF Transforaminal 510(k)
Pg 1 of 3
Section 5 - Page 2 of 4
1
K12C024
Product Description
MectaLIF Transforaminal lumbar intervertebral body fusion device is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). Mectal IF Transforaminal is used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK-OPTIMA LT1 and contain Tantalum Markers as well as a titanium gear which enables the surgeon to alter the angle of the MectaLIF Transforaminal in situ in 15° increments and to reposition during surgery without switching instrumentation. MectaLIF Transforaminal is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The dimensions of MectaLIF Transforaminal are within the following range: Length 30-34mm; Height 8-15mm; Width 12-14mm; Lordosis 5°. The materials of the components of MectaLIF Transforaminal are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026), Gear: Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and Marker: Tantalum (ISO 13782 / ASTM F 560).
Indications for Use
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
Comparison to Predicate Devices
MectaLIF Transforaminal is substantially equivalent in terms of indications for use, material, design, and performance characteristics as the previously cleared K110927 MectaLIF Oblique (Medacta Intl), K040536 Verte-Stack Boomerang (Medtronic), K072791 OPAL Spacer (Synthes), K081888 Dynamik (Spineart), K081917 Devex/Leopard (Depuy Spine), P960025 Lumbar IF Cage (Depuy Acromed), and K103034 Apache TLIF (Genesys Spine).
2
Performance Testing
MectaLIF Transforaminal has similar performance testing as the predicates in terms of:
Static Axial Compression - ASTM F2077 Dynamic Axial Compression - ASTM F2077 Static Compression/Shear - ASTM F2077 Dynamic Compression/Shear - ASTM F2077 Subsidence Resistance - ASTM F2267
Conclusion:
Based on the above information, MectaLIF Transforaminal can be considered as substantially equivalent to its predicate devices in terms of indications for use, material, design, and performance characteristics
Section 5 - Page 4 of 4
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medacta International SA % Medacta USA Mr. Adam Gross Director of Regulatory and Quality 4725 Calle Quetzal, Unit B Camarillo, California 93012
FEB 2 8 2012
Re: K120024
Trade/Device Name: MectaLJF Transforaminal Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 31, 2012 Received: February 01, 2012
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 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.
4
Page 2 - Mr. Adam Gross
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 70 http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
f.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
· 510(k) Number (if known):
Device Name: MectaLIF Transforaminal
Indications for Use:
The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.
| Prescription Use | x |
|---|---|
| (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) | |
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K120024 |
| MectaLIF Transforaminal 510(k) | |
| December 30, 2011 | Section 4 - Page 2 of 2 |
| Pg 1 of 1 |