(133 days)
No reference devices were found in the text.
No
The 510(k) summary describes a physical interbody fusion implant and its materials. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are focused on the mechanical properties and biocompatibility of the implant.
Yes.
The device is an implant used to treat degenerative disc disease by requiring interbody fusion, which aims to alleviate discogenic pain.
No
This device is an implantable interbody fusion device intended for treatment of degenerative disc disease, not for diagnosis.
No
The device description explicitly states it is an implant made of PEEK, Tantalum, and Titanium, which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the MectaLIF implants are physical devices intended for surgical implantation into the spine to treat degenerative disc disease. They are made of materials like PEEK and Titanium.
- Intended Use: The intended use is to provide interbody fusion in the spine, which is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic function on a biological sample. While patient history and radios (radiographic studies) are used to confirm the condition, the device's role is therapeutic (fusion), not diagnostic.
Therefore, the MectaLIF implants are medical devices, specifically surgical implants, and do not fall under the category of In Vitro Diagnostics.
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 radios. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
Product codes
MAX
Device Description
The subject MectaLIF Posterior Extension implants are line extension to the MectaLIF Posterior PEEK implants (K110927 and K131671) and MectaLIF Posterior TiPEEK implants (K133192).
The MectaLIF Posterior Interbody Fusion implants are used to to treat degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. The devices are not intended to be coupled with other implants but are intended to be used with a supplementary fixation as posterior fixation or with autogenous bone graft.
The subject devices provide an enlarged MectaLIF Posterior implants product range through the introduction of implants with width 9mm, length 22 and 25mm, height from 7 to 15mm, lordosis 0°, 5°, and 10°. This range extension is carried out in order to better cover the patient population.
The MectaLIF Posterior Extension implants have been designed with the same or similar shape, dimensions and materials as the previously cleared MectaLIF (K110927). Medacta MectaLIF Extension (K131671), Medacta MectaLIF TiPEEK (K133192), and Aesculap ProSpace88 Interbody System (K071983).
The subject MectaLIF Posterior Extension implants are manufactured by the following materials:
- MectaLIF Posterior PEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM ● F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications); and
- MectaLIF Posterior TiPEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM ● F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications) + Titanium surface coating (CPTi (ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants), Spondycoat-T 371A).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 - S1 (spinal levels)
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)
Non-Clinical Studies:
- Characterization Test
- Design Validation
- Performance Tests
- static and dynamic axial compression: ASTM F2077-17 Test Methods For Intervertebral Body Fusion Devices
- static and dynamic shear compression: ASTM F2077-17 Test Methods For Intervertebral Body Fusion Devices
- subsidence: ASTM F2267-04 (2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- abrasion resistance: ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
- static tensile strength: ASTM 1147-2017 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- static shear strength: ASTM F 1044-05 (2017) Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
- fatigue shear strength: ASTM F1160-14 (2017) Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
- micrographical analysis: ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
- wear analysis: ASTM F2077-17 Test Methods For Intervertebral Body Fusion Devices, ASTM 1877-16 Standard Practice for Characterization of Particles, ISO 17853:2011 Wear of implant materials -- Polymer and metal wear particles -- Isolation and characterization
- Pyrogenicity
- Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- the subject devices are not labeled as non-pyrogenic or pyrogen free
No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110927, K131671, K133192, K071983
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
December 4, 2018
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K181970
Trade/Device Name: MectaLIF Posterior Extension Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 20, 2018 Received: July 24, 2018
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -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) K181970
Device Name MectaLIF Posterior Extension
Indications for Use (Describe)
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 radios. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. Submitter
Medacta USA 3973 Delp Street Memphis, TN 38118 Phone (901)203-3470 Contact Person: Chris Lussier, Director, Quality and Regulatory, Medacta USA
Date Prepared: July 20, 2018
II. Device
| Device Proprietary Name: | MectaLIF Posterior Extension |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Primary Product Code: | MAX |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification | II |
III. Predicate Device
Primary Predicate: MectaLIF - K110927, Medacta International SA
Additional Predicates:
MectaLIF Extension - K131671, Medacta International SA MectaLIF TiPEEK - K133192, Medacta International SA ProSpaceXP Interbody System - K071983, Aesculap
IV. Device Description
The subject MectaLIF Posterior Extension implants are line extension to the MectaLIF Posterior PEEK implants (K110927 and K131671) and MectaLIF Posterior TiPEEK implants (K133192).
The MectaLIF Posterior Interbody Fusion implants are used to to treat degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. The devices are not intended to be coupled with other implants but are intended to be used with a supplementary fixation as posterior fixation or with autogenous bone graft.
4
The subject devices provide an enlarged MectaLIF Posterior implants product range through the introduction of implants with width 9mm, length 22 and 25mm, height from 7 to 15mm, lordosis 0°, 5°, and 10°. This range extension is carried out in order to better cover the patient population.
The MectaLIF Posterior Extension implants have been designed with the same or similar shape, dimensions and materials as the previously cleared MectaLIF (K110927). Medacta MectaLIF Extension (K131671), Medacta MectaLIF TiPEEK (K133192), and Aesculap ProSpace88 Interbody System (K071983).
The subject MectaLIF Posterior Extension implants are manufactured by the following materials:
- MectaLIF Posterior PEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM ● F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications); and
- MectaLIF Posterior TiPEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM ● F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications) + Titanium surface coating (CPTi (ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants), Spondycoat-T 371A).
V. 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.
VI. Comparison of Technological Characteristics
The MectaLIF Posterior Extension implants and the predicate devices share the following characteristics:
- design;
- materials;
- device usage;
- sterility; ●
- shelf life; and ●
5
· packaging.
The subject devices are substantially equivalent to the Medacta predicate devices (K110927, K131671, and K133192) with the exception of the 9 mm width dimension. An additional predicate (K071983) was identified to demonstrate substantially equivalent width of 8.5 mm.
Biocompatibility testing was conducted on the predicate devices for the same or similar materials to support the biological safety of the MectaLIF Posterior Extension implants.
Performance Data VII.
Testing was conducted according to written protocols with acceptance criteria that were based The following mechanical studies were performed in standards. support on of a substantial equivalence determination:
Non-Clinical Studies:
- Characterization Test
- o Design Validation
- Performance Tests
- static and dynamic axial compression: ASTM F2077-17 Test Methods For o Intervertebral Body Fusion Devices
- static and dynamic shear compression: ASTM F2077-17 Test Methods For O Intervertebral Body Fusion Devices
- subsidence: ASTM F2267-04 (2018) Standard Test Method for Measuring Load o Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- abrasion resistance: ASTM F1978-18 Standard Test Method for Measuring Abrasion о Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
- static tensile strength: ASTM 1147-2017 Standard Test Method for Tension Testing of O Calcium Phosphate and Metallic Coatings
- static shear strength: ASTM F 1044-05 (2017) Standard Test Method for Shear Testing o of Calcium Phosphate Coatings and Metallic Coatings
- fatigue shear strength: ASTM F1160-14 (2017) Standard Test Method for Shear and o Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
- micrographical analysis: ASTM F1854-15 Standard Test Method for Stereological о Evaluation of Porous Coatings on Medical Implants
- wear analysis: O
- 0 ASTM F2077-17 Test Methods For Intervertebral Body Fusion Devices
- o ASTM 1877-16 Standard Practice for Characterization of Particles
- o ISO 17853:2011 Wear of implant materials -- Polymer and metal wear particles -- Isolation and characterization
6
- Pyrogenicity ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- the subject devices are not labeled as non-pyrogenic or pyrogen free o
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
Based on the above information, the MectaLIF Posterior Extension implants are substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations. The MectaLIF Posterior Extension implants are as safe and effective as the predicate devices MectaLIF (K110927), MectaLIF Extension (K131671), MectaLIF TiPEEK (K133192), and ProSpace88 Interbody System (K071983).