The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:

Hip: acetabular labral repair
Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

Device Description

The SnugFit All-Suture Anchor is an implantable device indicated for the treatment of hip and shoulder instability (Size 1) and shoulder rotator cuff repair and biceps tenodesis (Size 2).
The SnugFit All-Suture Anchor is a knotted device composed entirely of sutures, made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) specifically arranged and braided to create an anchoring point within the bone after its deployment. The sutures that compose the anchor, are also used to secure soft tissues to a supporting structure (i.e. bone).
The SnugFit All-Suture Anchors are provided EtO sterile with a 5 years shelf life. The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is provided pre-loaded on the disposable driver.
The SnugFit All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded sutures.

AI/ML Overview

The provided FDA 510(k) summary for the Medacta International SA SnugFit All-Suture Anchor does not contain information regarding acceptance criteria or a study proving the device meets said criteria in the context of diagnostic accuracy or AI performance.

This document is a premarket notification for a medical device (an all-suture anchor for soft tissue fixation to bone), not a diagnostic algorithm or AI-powered device that would typically involve acceptance criteria related to sensitivity, specificity, accuracy, or human reader performance.

The "Performance Data" section lists non-clinical studies related to the physical performance and safety of the implantable device. These studies are mechanical evaluations, biocompatibility tests, and sterilization validations, which are standard for orthopedic implants.

Here's why the requested information cannot be extracted from this document:

Type of Device: The SnugFit All-Suture Anchor is a physical implant used in surgery, not a diagnostic imaging tool, AI algorithm, or device that performs an analytical function.
Performance Data focus: The performance data described (design validation, cyclic and load-to-failure properties, pyrogenicity, biocompatibility) are all related to the mechanical properties, material safety, and physical integrity of the anchor, not diagnostic accuracy.
Absence of AI/Diagnostic Context: There is no mention of AI, diagnostic imaging, disease detection, or human reader studies.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information contained in the provided FDA submission for this particular device.

Summary

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January 19, 2021

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

Re: K203485

Trade/Device Name: SnugFit All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 25, 2020 Received: November 27, 2020

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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K203485

Device Name SnugFit All-Suture Anchor

Indications for Use (Describe)

The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for

fixation of soft tissue to bone in the hip and shoulder in the following procedures:

Hip: acetabular labral repair
Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

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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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, Director of Quality and Regulatory, Medacta USA Date Prepared: November 25, 2020 Date Revised: January 19, 2021

II. Device

Device Proprietary Name:	SnugFit All-Suture Anchor
Common or Usual Name:	Soft Tissue Fixation Device
Classification Name:	Fastener, Fixation, Non-degradable, Soft Tissue
Primary Product Code:	MBI
Regulation Number:	21 CFR 888.3040
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following primary predicate device:

JuggerKnot Soft Anchors, K150768, Biomet Manufacturing Corp.
The following has been identified as a secondary predicate device:
MectaLock All-Suture Anchor, K193461, Medacta International SA
In addition, the following reference devices are referenced within the submission:
MectaLock PEEK Suture Anchor, K190474, Medacta International SA A

IV. Device Description

The SnugFit All-Suture Anchor is an implantable device indicated for the treatment of hip and shoulder instability (Size 1) and shoulder rotator cuff repair and biceps tenodesis (Size 2).

The SnugFit All-Suture Anchor is a knotted device composed entirely of sutures, made of ultra-high molecular weight polyethylene (UHMWPE) and polyester (PET) specifically arranged and braided to

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create an anchoring point within the bone after its deployment. The sutures that compose the anchor, are also used to secure soft tissues to a supporting structure (i.e. bone).

The SnugFit All-Suture Anchors are provided EtO sterile with a 5 years shelf life. The sterile, individually packaged, devices consist of the all-suture anchor and a disposable stainless steel driver with a plastic handle. The all-suture anchor is provided pre-loaded on the disposable driver.

The SnugFit All-Suture Anchors are available in six (6) different configurations depending on anchor size (size 1 and size 2), driver length (long and short), and typology of preloaded sutures.

V. Indications for Use

The SnugFit All-Suture Anchor is intended for use in arthroscopic or open surgical approaches for fixation of soft tissue to bone in the hip and shoulder in the following procedures:

Hip: acetabular labral repair
Shoulder: glenoid labrum repair; rotator cuff repair, biceps tendon repair

VI. Comparison of Technological Characteristics

The SnugFit All-Suture Anchor and the predicate device share the following characteristics:

anchor deployment and fixation mechanism;
disposable driver design;
materials;
biocompatibility;
device usage;
sterility; and
packaging.

The SnugFit All-Suture Anchor differs from the predicate device with respect to:

. anchor sizes; and
preloaded sutures.

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

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SnugFit All-Suture Anchor Design Validation Report Test Report A1 according to Design о Validation Protocol M07.85.003 Nr. A1 and Evaluation forms
PERFORMANCE TESTING ●
- MR Safety evaluation SnugFit All-Suture Anchor o
- Cyclic and load-to-failure properties of SnugFit All-Suture Anchor Test Report A2 o according to Test Protocol IL 07.09.575 Rev.1 and Empa Test Report No. 5214025866 1e
PYROGENICITY ●
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
- o Pyrogen test according to USP chapter <151> for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
BIOCOMPATIBILITY evaluation

Clinical Studies:

No clinical studies were conducted.

VIII. Conclusion

Based on the information provided within this submission, the SnugFit All-Suture Anchor is 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.