The MectaScrew Extension includes implantable devices used for the tibial and the femoral fixation of the graft in reconstructive treatment of knee ligament ruptures. They have been developed to provide interference between a ligament graft and a bone tunnel in the ligament reconstruction surgery.

The MectaScrew Extension implants includes MectaScrew C, a composite interference screw made of RESOMER® Composite LR 706S B-TCP, a mixture of 70 % RESOMER® LR 706 S and 30 % B-TCP.

MectaScrew C is available in 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "MectaScrew Extension." This document outlines the device's characteristics, its intended use, and its comparison to predicate devices to establish substantial equivalence.

Crucially, the document states: "No clinical studies were conducted." This means there is no study evaluating the device's performance against pre-defined acceptance criteria with human subjects or actual clinical outcomes in the format you've requested.

Therefore, I cannot provide information on:

A table of acceptance criteria and reported device performance (as no clinical performance criteria or results are given).
Sample size used for the test set and data provenance.
Number of experts and their qualifications used to establish ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study or its effect size.
Standalone performance.
Type of ground truth used (as no clinical ground truth was established from a study).
Sample size for the training set (no AI/ML component described).
How ground truth for the training set was established (no AI/ML component described).

The document focuses on non-clinical studies (design validation, performance testing like torque resistance and pull-out strength, MR safety, pyrogenicity, and biocompatibility) to demonstrate substantial equivalence to predicate devices. These non-clinical tests would have their own internal acceptance criteria, but these are not for the "device performance" in the clinical sense you are asking for.

In summary, based on the provided text, the MectaScrew Extension did not undergo a clinical study to prove its performance against acceptance criteria in human use. Its clearance was based on demonstrating substantial equivalence through non-clinical data and comparison to existing legally marketed devices.

Summary

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February 3, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K203335

Trade/Device Name: MectaScrew Extension Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 3, 2022 Received: January 5, 2022

Dear Chris 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

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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,

for

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203335

Device Name MectaScrew Extension

Indications for Use (Describe)

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allografts.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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: November 12, 2020 Date Revised: February 2, 2022

II. Device

Device Proprietary Name:	MectaScrew Extension
Common or Usual Name:	Screw, fixation, bone
Classification Name:	Smooth or threaded metallic bone fixation Fastener
Primary Product Code:	HWC
Regulation Number:	21 CFR 888.3040
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following primary predicate device:

KSEA Megafix-C Bioabsorbable Composite Interference Screw, K071437, Karl Storz A Endoscopy - America, Inc
Substantial equivalence is claimed to the following secondary predicate device:
MectaScrew PEEK, K190892, Medacta International SA A

Device Description IV.

The MectaScrew Extension implants includes MectaScrew C, a composite interference screw made of RESOMER® Composite LR 706S B-TCP, a mixture of 70 % RESOMER® LR 706 S and 30 % B-TCP.

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MectaScrew C is available in 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.

V. Indications for Use

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allografts.

VI. Comparison of Technological Characteristics

The MectaScrew Extension implants and the predicate device (K071437) share the following characteristics:

shape ●
materials;
biocompatibility;
device usage;
sterility; and
packaging.

The MectaScrew Extension implants differ from the predicate device (K071437) with respect to:

. screw diameters;
screw lengths; and
driver connection. ●

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 ●
- MectaScrew C Design Validation Report Test Report 48 according to Design Validation o Protocol M07.85.003 Nr. A8
PERFORMANCE TESTING ●
- MR Safety evaluation Composite Interference Screw o

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Torque resistance of graft fixation device for ACL reconstruction: interference screw. O according to Test Protocol IL 07.09.485 Rev.2 and Empa Test Reports No. 5214022874 and 5214025594/1e
Pull out strength of graft fixation device for ACL reconstruction: interference screw, o Rationale A3
MectaScrew C Endurance properties with respect to the degradation phenomena, Rationale о A2
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 or pyrogen free.
BIOCOMPATIBILITY
- o Biocompatibility assessment as per ISO 10993 series and FDA Biocompatibility Guidance document Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Clinical Studies:

No clinical studies were conducted. ●

VIII. Conclusion

Based on the information provided within this submission, the MectaScrew 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.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.