(150 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant, with no mention of AI or ML.
Yes.
The device is an interbody fusion device for patients with degenerative disc disease, which is a condition requiring medical treatment. Its intended use is to treat a medical condition and alleviate symptoms, qualifying it as a therapeutic device.
No
This device is an interbody fusion device, specifically an implant used for treating degenerative disc disease, not for diagnosing it.
No
The device description explicitly states it consists of physical implants made of PEEK, titanium, and tantalum, including disc spacers, plates, and screws. 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 detect diseases, conditions, or infections.
- Device Description: The MectaLIF Anterior is an implantable device designed for spinal fusion. It is surgically placed into the intervertebral space.
- Intended Use: The intended use is to provide structural support and facilitate fusion in patients with degenerative disc disease. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a surgically implanted device used for treatment, not a diagnostic tool.
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 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
MAX, OVD
Device Description
The subject MectaLIF Anterior Extension implants are a line extension designed to provide a larger product offering in Medacta MectaLIF Anterior portfolio.
The MectaLIF Anterior 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. The family of MectaLIF Anterior system features two designs:
- MectaLIF Anterior Stand-Alone Fusion Device System, which is a system consisting of cages, plates and is intended to be used with bone screws provided and requires no additional supplementary fixation.
- MectaLIF Anterior Simple, which is a cage/plate system requiring additional supplementary fixation.
The purpose of this submission is to introduce new cages footprints as well as new plates and screws designs.
Identically to already cleared MectaLIF Anterior implants, the subject MectaLIF Anterior Extension implants consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026) body coated with commercially pure titanium (CPT), ASTM F1580). The spacers contain tantalum markers (ISO 13782 / ASTM F560) and include a flush plate secured to the vertebral body with 4 bone screws. Both the plates and the screws are made of Ti6A14V ELI (ISO 5832-3/ASTM F136). The flush plate is secured to the disc spacer via an interlocking mechanism and it is available in two designs lock and lag where an additional anti-back-out cover plate is used to reduce the risk of screw migration after the implantation. The interior of the disc spacer can be packed with autograft or autologous bone graft.
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
Prescription Use
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
Non-Clinical Studies:
- DESIGN VALIDATION
- MectaLIF Anterior Design Validation Report
- PERFORMANCE TESTING
- Mechanical standard tests on MectaLIF Anterior interbody fusion devices according to ASTM F2077-18 Test Methods For Intervertebral Body Fusion Devices and ASTM F2267-04 (reapproved 2018) Standard Test Method for Measuring Load Induced subsidence of Intervertebral Body Fusion Device under Static Axial Compression including:
- static and dynamic axial compression test
- static and dynamic shear compression test
- static and dynamic shear compression test without pockets
- static and dynamic torsion test
- axial compressive subsidence test
- static expulsion test
- MectaLIF Anterior lag screws static tests according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws including:
- static torsion strength test, including breaking angle
- insertion and removal torque test
- pull-out strength test
- Wear analysis of TiPEEK coated intervertebral body fusion devices according to ISO 17853:2011 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization and ASTM F1877-16 Standard Practice for Characterization of Particles
- Mechanical standard tests on MectaLIF Anterior interbody fusion devices according to ASTM F2077-18 Test Methods For Intervertebral Body Fusion Devices and ASTM F2267-04 (reapproved 2018) Standard Test Method for Measuring Load Induced subsidence of Intervertebral Body Fusion Device under Static Axial Compression including:
- 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 assessment
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
K124034, K160605, K170455, K102738
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
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October 24, 2022
Medacta International S.A. % Mr. Chris Lussier Senior Director, Quality, Regulatory, and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K221545
Trade/Device Name: MectaLIF Anterior Extension Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: September 23, 2022 Received: September 26, 2022
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
1
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) K221545
Device Name MectaLIF Anterior Extension
Indications for Use (Describe)
The MectaLF 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 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K221545 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, Senior Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: May 25, 2022 Date Revised: June 28, 2022
II. Device
| Device Proprietary Name: | MectaLIF Anterior Extension |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, |
| Lumbar | |
| Primary Product Code: | OVD |
| Regulation Number: | 21 CFR 888.3080 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices: Primary predicate device:
-
MectaLIF Anterior, K124034, Medacta International SA
Additional predicate devices: -
MectaLIF Anterior Stand Alone, K160605, Medacta International SA
-
MectaLIF Anterior Stand Alone, K170455, Medacta International SA
-
A Lanx Fusion System, K102738, Lanx Inc.
IV. Device Description
The subject MectaLIF Anterior Extension implants are a line extension designed to provide a larger product offering in Medacta MectaLIF Anterior portfolio.
4
The MectaLIF Anterior 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. The family of MectaLIF Anterior system features two designs:
- MectaLIF Anterior Stand-Alone Fusion Device System, which is a system consisting of cages, . plates and is intended to be used with bone screws provided and requires no additional supplementary fixation.
- MectaLIF Anterior Simple, which is a cage/plate system requiring additional supplementary ● fixation.
The purpose of this submission is to introduce new cages footprints as well as new plates and screws designs.
Identically to already cleared MectaLIF Anterior implants, the subject MectaLIF Anterior Extension implants consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026) body coated with commercially pure titanium (CPT), ASTM F1580). The spacers contain tantalum markers (ISO 13782 / ASTM F560) and include a flush plate secured to the vertebral body with 4 bone screws. Both the plates and the screws are made of Ti6A14V ELI (ISO 5832-3/ASTM F136). The flush plate is secured to the disc spacer via an interlocking mechanism and it is available in two designs lock and lag where an additional anti-back-out cover plate is used to reduce the risk of screw migration after the implantation. The interior of the disc spacer can be packed with autograft or autologous bone graft.
Indications for Use V.
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.
Comparison of Technological Characteristics VI.
The MectaLIF Anterior Extension implants and the Medacta predicate devices (K124034. K160605 and K170455) are substantially equivalent with regards to the following characteristics:
- lordosis:
- screw sizes and tip: ●
- . materials:
- . coating:
- . biocompatibility:
- . device usage:
5
- sterility; ●
- . shelf life; and
- packaging. ●
The MectaLIF Anterior Extension implants differ from the Medacta predicate devices (K124034, K160605 and K170455) with respect to:
- cages footprints; ●
- bone graft volume: and
- lag design, including lag plates, lag screws and cover plate.
VII. Performance Data
Based on the risk analysis, design validation and performance testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION
- 0 MectaLIF Anterior Design Validation Report
- PERFORMANCE TESTING ●
- о Mechanical standard tests on MectaLIF Anterior interbody fusion devices according to ASTM F2077-18 Test Methods For Intervertebral Body Fusion Devices and ASTM F2267-04 (reapproved 2018) Standard Test Method for Measuring Load Induced subsidence of Intervertebral Body Fusion Device under Static Axial Compression including:
- static and dynamic axial compression test ■
- I static and dynamic shear compression test
- static and dynamic shear compression test without pockets
- static and dynamic torsion test I
- axial compressive subsidence test ■
- static expulsion test
- o MectaLIF Anterior lag screws static tests according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws including:
- static torsion strength test, including breaking angle
- l insertion and removal torque test
- 트 pull-out strength test
- Wear analysis of TiPEEK coated intervertebral body fusion devices according to ISO о 17853:2011 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization and ASTM F1877-16 Standard Practice for Characterization of Particles
- о Mechanical standard tests on MectaLIF Anterior interbody fusion devices according to ASTM F2077-18 Test Methods For Intervertebral Body Fusion Devices and ASTM F2267-04 (reapproved 2018) Standard Test Method for Measuring Load Induced subsidence of Intervertebral Body Fusion Device under Static Axial Compression including:
- PYROGENICITY ●
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
6
- o Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY assessment .
- . SHELF-LIFE evaluation
Clinical Studies:
- . No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the MectaLIF Anterior Extension implants are substantially equivalent to the predicate devices.