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.

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 various sizes of MectaLIF Oblique and MectaLIF Posterior implants with different widths, lengths, heights, and lordosis angles. The implants are made of implant grade Polyetherketone and have markers made of Tantalum. The devices are available both uncoated or coated with commercially pure titanium coating.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MectaLIF Extension device.

It's important to note that the document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within this context of demonstrating equivalence through non-clinical performance data rather than a full-scale clinical trial.

Acceptance Criteria and Device Performance for MectaLIF Extension (Based on 510(k) Summary)

Based on the provided FDA 510(k) summary (K212831), the "acceptance criteria" for the MectaLIF Extension are implicitly tied to demonstrating performance comparable to its predicate devices, aligning with relevant ASTM and ISO standards for intervertebral body fusion devices. The study proving these criteria are met consists primarily of non-clinical (benchtop) performance testing. No clinical studies were conducted for this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implicit)	Specific Tests / Standards (Performance Data)	Reported Device Performance (Summary from Document)
Mechanical Performance	- Static and dynamic axial compression test (ASTM F2077-18) - Static and dynamic shear compression test (ASTM F2077-18) - Axial compressive subsidence test (ASTM F2077-18) - Measuring Load Induced subsidence (ASTM F2267-04) - Expulsion Test rationale (Implied adherence to performance requirements)	Design validation and performance testing conducted to written protocols. Implied to meet or exceed relevant predicate device and standard requirements.
Material Properties & Coating Performance	- TiPEEK coating validation (ASTM F1854-15 for stereological evaluation of porous coatings; ASTM F1147-05 for tension testing) - Wear analysis of TiPEEK coated devices (ISO 17853:2011; ASTM F1877-16)	Adherence to relevant ASTM and ISO standards for material and coating validation. Implied acceptable performance.
Biocompatibility & Sterility	- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>) - Pyrogen test according to USP chapter <151> - Biocompatibility assessment (General statement, implying tests like cytotoxicity, sensitization, irritation performed per ISO 10993) - Sterility Validation	Tests were conducted. Devices are not labeled as non-pyrogenic. Implied to meet biocompatibility and sterility requirements.
Shelf-Life & Packaging	- Shelf-life evaluation - Packaging validation	Evaluation/validation done. Implied acceptable.
Design Integrity (New Sizes/Lordosis/Volume)	- Design Validation Report for MectaLIF Oblique 10mm width instrument/implant interface (specific to one of the new configurations, implies assessment of fit, function, and instrument compatibility for new sizes/lordosis)	Conducted as part of design validation to written protocols. Implied suitable.

Note: The document states that "Based on the risk analysis, design validation and performance testing were conducted to written protocols." and lists the specific tests. The detailed quantitative results (e.g., exact load values survived, specific wear rates) are not included in this public summary but would be part of the full 510(k) submission. The "reported device performance" in this context is the statement that these tests were conducted and support the claim of substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes (number of devices tested) for each non-clinical performance test (e.g., how many cages underwent axial compression testing). These numbers are typically defined by the specific ASTM/ISO standards referenced.
Data Provenance: The tests are explicitly non-clinical (benchtop mechanical, material, and biological tests).
- Country of Origin: The submitter is "Medacta International SA, Strada Regina 6874 Castel San Pietro (CH) Switzerland." The testing would presumably have been performed in a lab accredited to conduct these tests, likely in Switzerland or a country with recognized testing facilities.
- Retrospective or Prospective: Not applicable as these are benchtop tests, not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This concept is not applicable in this context. For a 510(k) submission primarily relying on non-clinical performance data, there is no "ground truth" derived from expert clinical opinion or patient outcomes in the same way there would be for an AI/CADe device submitting clinical study results. The "ground truth" for non-clinical tests is established by:

The measurement equipment and its calibration.
The test methods defined by recognized standards (e.g., ASTM, ISO), which dictate how a device's performance characteristic is measured.
The acceptance criteria set by the manufacturer (and implicitly accepted by the FDA for substantial equivalence) based on predicate device performance and standard requirements.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic accuracy or image review, to resolve discrepancies between readers or to establish a definitive diagnosis as ground truth. Since this submission relies on non-clinical benchtop testing, there are no human readers or clinical cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Studies: No clinical studies were conducted." This type of study would be relevant for a device intended to aid in clinical diagnosis or treatment decisions by human readers, typically for AI/CADe.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone performance evaluation (as defined for AI algorithms) was not done. This device is an intervertebral body fusion implant, not software or an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for determining acceptance for this device is based on:

Engineering Standards and Specifications: Adherence to defined physical and mechanical properties, material composition, and dimensions as tested against industry standards (ASTM F2077, F2267, F1854, F1147) and biocompatibility standards (ISO, USP, European Pharmacopoeia).
Predicate Device Equivalence: The primary "ground truth" for a 510(k) clearance is demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device regarding safety and effectiveness. This means the performance characteristics of the new device are comparable to, or better than, the predicate devices based on the non-clinical tests.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical implant, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

This concept is not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm requiring a training set and associated ground truth establishment.

Summary

{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)

K212831

Device Name MectaLIF Extension

Indications for Use (Describe)

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}------------------------------------------------

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

{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

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
PYROGENICITY
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia $2.6.14 (which is equivalent to USP chapter <85>)
- 0 Pyrogen test according to USP chapter <151> 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.

Regulation Number and Section

§ 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.

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(k) Summary

I. Submitter

II. Device

III. Predicate Device

IV. Device Description

V. Indications for Use

VI. Comparison of Technological Characteristics

VII. Performance Data

Non-Clinical Studies

VIII. Conclusion

§ 888.3080 Intervertebral body fusion device.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW