Grappler Suture Anchor System by Paragon 28, Inc.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction, TFCC

Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

Hip: Capsular Repair, Acetabular Labral Repair

The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

Device Description

The Grappler Suture Anchor System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and are accompanied by suture tape composed of UHMWPE.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Grappler Suture Anchor System. It asserts substantial equivalence to a predicate device and includes information about performance testing. However, it does not describe a study involving an AI algorithm or human readers.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves a device meets acceptance criteria in the context of AI performance or human reader interaction as it is not present in the provided text.

Specifically, the document does not contain:

A table of acceptance criteria and reported device performance related to AI.
Details about a test set (sample size, data provenance) for an AI study.
Information on experts used for ground truth establishment for an AI study.
Adjudication methods for an AI test set.
Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
Stand-alone (algorithm-only) performance data.
Ground truth type for an AI study (e.g., pathology, outcomes).
Sample size or ground truth establishment method for an AI training set.

The performance testing mentioned in the document refers to "engineering analysis" and "bacterial endotoxin testing" to demonstrate that modifications to the device do not adversely affect its original performance and that it meets specified safety criteria. This is standard for demonstrating substantial equivalence for a physical medical device, not an AI or diagnostic tool.

Summary

{0}------------------------------------------------

September 14, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Paragon 28, Inc. Haylie Hertz Sr. Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112

Re: K222091

Trade/Device Name: Grappler Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: July 13, 2022 Received: July 15, 2022

Dear Haylie Hertz:

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

{1}------------------------------------------------

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, PhD 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K222091

Device Name Grappler Suture Anchor System

Indications for Use (Describe)

The Grappler Suture Anchor System is intended for the fixation of soft tissue to bone including:

Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC

Hip: Capsular Repair, Acetabular Labral Repair

The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

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

510(K) SUMMARY

510(k) Number:	K222091
Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112
Contact:	Haylie HertzSr. Regulatory Affairs SpecialistParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 303-720-0017hhertz@paragon28.com
Date Prepared:	September 14, 2022
Device Trade Name:	Grappler Suture Anchor System
Device Class andCommon Name:	Class II, Fastener, Fixation, Nondegradable, Soft Tissue
Classification:	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Product Codes:	MBI
Indications for Use:	The Grappler Suture Anchor System is intended for the fixation of softtissue to bone including:
	Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair,Tennis Elbow Repair
	Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair,Biceps Tenodesis, Acromio-Clavicular Separation Repair, DeltoidRepair, Capsular Shift or Capsulolabral Repair
	Hand/Wrist : Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction, TFCC.
	Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould,Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization(Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal
	Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction,Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair
	Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis,Extra Capsular Reconstruction, Patellar Ligament and Tendon AvulsionRepair
	Hip: Capsular Repair, Acetabular Labral Repair
	The plate interacting anchors are only indicated for the above Hand/Wristand Foot/Ankle indications.
Device Description:	The Grappler Suture Anchor System consists of suture anchors, suture, andthe accompanying instrumentation for the intended use of soft tissuedamage repair. The anchors are provided in titanium and are accompaniedby suture tape composed of UHMWPE.
Predicate Device:	Grappler Suture Anchor System (K211002)
Reference Devices:	Baby Gorilla®/Gorilla® Plating System (K221465)R3ACT Stabilization System (K211770)
SubstantialEquivalence:	The proposed Grappler Suture Anchor System are substantially equivalentto the predicate Grappler Suture Anchor System (K211002) with respectto indications, design, material and function.
PerformanceTesting:	Engineering analysis is presented to provide evidence that the originaltesting and subsequent performance is not adversely affected by themodifications to the subject devices. The results of the analysisdemonstrated the modified designs are substantially equivalent to thepredicate devices. Bacterial endotoxin testing was conducted and the testresults meet acceptance criteria.
Conclusions:	The Grappler Suture Anchor System subject to this submission possessesthe same intended use and has similar technological characteristics as thepredicate device system components. Differences between the GrapplerSuture Anchor System and the predicate device were not shown to raisenew questions of safety and effectiveness (i.e anchor diameter, dynamictechnology, plate interacting technology). All performance testingconducted for the Grappler Suture Anchor System met the predeterminedacceptance criteria or were otherwise considered acceptable. As such, theGrappler Suture Anchor System components are substantially equivalentto the predicate devices for the intended use.

{4}------------------------------------------------

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.