(52 days)
No
The 510(k) summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
The device is indicated for use in patients with degenerative disc disease to restore spinal height, implying a therapeutic purpose to treat a medical condition.
No
The device is an implant for fusion in patients with degenerative disc disease, not a tool for diagnosing the condition.
No
The device description clearly states it is a line of implants made of Polyetherketone and Tantalum, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (MectaLIF implants) used to replace a degenerative disc in the spine. It is a physical device implanted into the body.
- Intended Use: The intended use is for surgical fusion of spinal levels in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant, not an in vitro diagnostic device.
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
MAX
Device Description
The subject MectaLIF Extension implants are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671 and K181970) and MectaLIF Oblique and Posterior TiPEEK implants (K133192 and K181970). MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft.
The subject MectaLIF Extension includes the following implants:
- MectaLIF Oblique with width 12mm, new length 24mm, height from 7 to 15mm, lordosis 0°, 5° and 10°
- MectaLIF Oblique with new width 10, length from 24 to 36, height from 7 to 15, lordosis 0°, 5° and 10°
- MectaLIF Posterior with width 9mm and 11mm, new length 19mm, height from 7 to 15mm, lordosis 0°, 5°, 10°, 15° and 20°
- MectaLIF Posterior with width 9mm and 11mm, length 19mm, 22mm and 25mm, height from 9 to 15mm, new lordosis 12°
- MectaLIF Posterior with width 9mm, length 19mm, 22 and 25mm, height from 13 to 15mm, new lordosis 15° and 20°
The MectaLIF Extension implants are made of implant grade Polyetherketone according to ASTM F2026-17 and they have marker made of Tantalum according to ISO 13782:2019 and ASTM F560-17.
The subject devices are available both uncoated or coated with commercially pure titanium coating according to ASTM F1580-18.
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
Skeletally mature patients
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
Non-Clinical Studies:
- DESIGN VALIDATION
- MectaLIF Oblique 10mm width instrument/implant interface, Design Validation Report
- PERFORMANCE TESTING
- Mechanical standard tests on MectaLIF Oblique and MectaLIF Posterior lumbar cages for interbody fusion 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
- axial compressive subsidence test
- TiPEEK coating validation according to ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants and ASTM F1147-05 (reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- 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
- Expulsion Test rationale
- Mechanical standard tests on MectaLIF Oblique and MectaLIF Posterior lumbar cages for interbody fusion 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
- BIOCOMPATIBILITY ASSESSMENT
- SHELF-LIFE EVALUATION
Clinical Studies: - No clinical studies were conducted
Key Metrics
Not Found
Predicate Device(s)
K133192, K130699, K110927, K131671, K181970
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2021
Medacta International S.A. % Mr. Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K212831
Trade/Device Name: MectaLIF Extension Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 3, 2021 Received: September 7, 2021
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 medical devices and radiation-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 L. 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)
Device Name MectaLIF 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 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.
| 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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3
Medacta International SA
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 of Quality and Regulatory, Medacta USA Date Prepared: October 22, 2021
II. Device
| Device Proprietary Name: | MectaLIF 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
Substantial equivalence is claimed to the following primary predicate device:
-
MectaLIF TiPEEK, K133192, Medacta International SA
In addition, the following additional predicate devices are cited within the submission: -
A Aleutian IBF System, K130699, K2M, Inc.
-
A MectaLIF, K110927, Medacta International SA
-
A MectaLIF Extension, K131671, Medacta International SA
-
MectaLIF Posterior Extension, K181970, Medacta International SA A
IV. Device Description
The subject MectaLIF Extension implants are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671 and K181970) and MectaLIF Oblique and Posterior TiPEEK implants (K133192 and K181970).
4
MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft.
The subject MectaLIF Extension includes the following implants:
- MectaLIF Oblique with width 12mm, new length 24mm, height from 7 to 15mm, lordosis 0°, 5° and 10°
- . MectaLIF Oblique with new width 10, length from 24 to 36, height from 7 to 15, lordosis 0°, 5° and 10°
- MectaLIF Posterior with width 9mm and 11mm, new length 19mm, height from 7 to 15mm, lordosis 0°, 5°, 10°, 15° and 20°
- MectaLIF Posterior with width 9mm and 11mm, length 19mm, 22mm and 25mm, height from 9 ● to 15mm, new lordosis 12°
- MectaLIF Posterior with width 9mm, length 19mm, 22 and 25mm, height from 13 to 15mm, new ● lordosis 15° and 20°
The MectaLIF Extension implants are made of implant grade Polyetherketone according to ASTM F2026-17 and they have marker made of Tantalum according to ISO 13782:2019 and ASTM F560-17.
The subject devices are available both uncoated or coated with commercially pure titanium coating according to ASTM F1580-18.
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 Extension implants and the predicate devices share the following characteristics:
- . design:
- . materials:
- coating:
- biocompatibility: ●
- . device usage:
- . sterility:
- . shelf life: and
- packaging. ●
5
The MectaLIF Extension implants differ from the predicate devices with respect to:
- . range of product sizes;
- lordosis; and ●
- bone graft volume. ●
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 ●
- MectaLIF Oblique 10mm width instrument/implant interface, Design Validation Report O
- PERFORMANCE TESTING ●
- Mechanical standard tests on MectaLIF Oblique and MectaLIF Posterior lumbar cages for o interbody fusion 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
- l static and dynamic shear compression test
- I axial compressive subsidence test
- TiPEEK coating validation according to ASTM F1854-15 Standard Test Method for O Stereological Evaluation of Porous Coatings on Medical Implants and ASTM F1147-05 (reapproved 2017)e1 Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
- Wear analysis of TiPEEK coated intervertebral body fusion devices according to ISO O 17853:2011 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization and ASTM F1877-16 Standard Practice for Characterization of Particles
- Expulsion Test rationale O
- Mechanical standard tests on MectaLIF Oblique and MectaLIF Posterior lumbar cages for o interbody fusion 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 )
- 0 Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic
- BIOCOMPATIBILITY ASSESSMENT
- SHELF-LIFE EVALUATION ●
6
Medacta International SA
Clinical Studies:
- No clinical studies were conducted ●
VIII. Conclusion
The information provided above supports that the MectaLF Extension implants are substantially equivalent to the predicate devices.