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

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

Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Chrisman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid Repair, Spring Ligament Reconstruction), 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

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 PEEK, titanium, and suture materials in multiple sizes and lengths. Each anchor is accompanied by round suture or suture tape composed of UHMWPE and PGLA.

AI/ML Overview

This document is for a medical device called the "GRAPPLER™ Suture Anchor System," which is a physical device used to fix soft tissue to bone. It is not an AI/ML powered device, and therefore, does not have the types of acceptance criteria and study designs that would typically apply to such devices (e.g., diagnostic performance metrics like sensitivity, specificity, AUC, or MRMC studies for human-in-the-loop performance).

The document details the substantial equivalence determination for this device, comparing it to legally marketed predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and material testing to ensure the device performs as intended and is safe, rather than clinical performance studies measuring diagnostic accuracy or reader improvement.

Analysis of Acceptance Criteria and Device Performance (Based on Provided Text):

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not present the acceptance criteria in a formal table with specific numerical values or targets. Instead, it describes the types of tests performed and states that "All performance testing conducted for the GRAPPLER™ Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable."

Here's an interpretation based on the text:

Acceptance Criteria Category	Description of Performance Test	Reported Outcome
Mechanical Performance	Torsional strength	Met predetermined acceptance criteria
	Insertion/removal torque	Met predetermined acceptance criteria
	Pullout testing	Met predetermined acceptance criteria
	Tensile testing	Met predetermined acceptance criteria
Shelf Life/Stability	Real-time aging events	Validated
	Accelerated aging events	Validated
	Seal strength evaluation	Validated
	Visual inspection	Validated
	Dye penetration evaluation	Validated
	Pressurization evaluations	Validated
Sterility & Biocompatibility	Bioburden testing	Validated
	Bacterial endotoxin (LAL) testing	Verified (for pyrogenicity)

Notes:

The document states: "The device performance was characterized via torsional strength, insertion/removal torque, pullout testing and tensile testing."
"Device shelf life was validated through real time and accelerate aging events assessed with seal strength, visual inspection, dye penetration, pressurization evaluations."
"Device sterility was validated through bioburden testing. Pyrogenicity was verified through bacterial endotoxin (LAL) testing."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the sample sizes (e.g., number of anchors tested) for each of the performance tests (torsional strength, tensile, etc.). It only mentions that "All testing was performed on finished devices."
Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The data provenance refers to the results of in-house or contracted laboratory mechanical and material testing. The country of origin of this testing data is not specified. It is inherently "prospective" in the sense that the tests were conducted specifically for this submission.

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

Not applicable. This is a physical device, and its acceptance criteria are based on engineering and material performance standards, not on expert consensus for clinical interpretations or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable. Ground truth for mechanical testing is established by direct measurement against engineering specifications, not through expert adjudication.

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

No. An MRMC study is typically performed for AI-powered diagnostic devices to assess how the AI assists human readers. This device is a physical surgical implant, so an MRMC study is not relevant.

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

Not applicable. This is not an algorithm. The "standalone performance" refers to the mechanical and material performance of the device itself (e.g., its tensile strength, resistance to torque), which was indeed assessed through the tests mentioned.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on engineering specifications and established material and mechanical testing standards. For example, a suture anchor must withstand a certain pullout force, or its material must have a certain tensile strength. These are objective, measurable criteria, not subjective interpretations.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth establishment process.

Summary for this Specific Device:

The provided document is a 510(k) clearance letter for a physical medical device (suture anchor). The "acceptance criteria" and "study" described pertain to engineering and material performance testing, rather than clinical diagnostic performance or AI model validation. The FDA granted clearance based on the device demonstrating substantial equivalence to existing predicate devices, supported by data showing it meets relevant mechanical, material, sterility, and shelf-life requirements. The type of information requested in the prompt (e.g., MRMC studies, training/test sets for AI, expert adjudication) is typically relevant only for AI/ML-powered medical devices.

Summary

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July 7, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K211002

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: June 23, 2021 Received: June 28, 2021

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

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K211002

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, Biceps Tenodesis, 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

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.

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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:

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510(k) Number: K211002 Dated: June 23, 2021

510(K) SUMMARY

510(k) Number:	K211002
Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112
Contact:	Haylie HertzRegulatory Affairs SpecialistParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 303-720-0017hhertz@paragon28.com
Date Prepared:	June 23, 2021
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 fixationfastener
Product Codes:	MBI
Indications for Use:	The GRAPPLER™ Suture Anchor System is intended for thefixation of soft tissue to bone including:
	Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair,Tennis Elbow Repair
	Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP LesionRepair, Biceps Tenodesis, Acromio-Clavicular Separation Repair,Deltoid Repair, Capsular Shift or Capsulolabral Repair
	Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar orRadial Collateral Ligament Reconstruction, TFCC.

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	Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould,Chrisman-Snook Repair), Ankle Ligament Repair, MedialStabilization (Deltoid Repair, Spring Ligament Reconstruction),Achilles Tendon Repair, Metatarsal Ligament Repair, SyndesmosisRepair, Hallux Valgus Reconstruction, Digital Tendon Transfers,Mid-foot Reconstruction, LisFranc Repair
	Knee: Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Posterior Oblique Ligament Repair, IliotibialBand Tenodesis, Extra Capsular Reconstruction, Patellar Ligamentand Tendon Avulsion Repair
	Hip: Capsular Repair, Acetabular Labral Repair
Device Description:	The GRAPPLER™ Suture Anchor System consists of sutureanchors, suture, and the accompanying instrumentation for theintended use of soft tissue damage repair. The anchors are providedin PEEK, titanium, and suture materials in multiple sizes and lengths.Each anchor is accompanied by round suture or suture tape composedof UHMWPE and PGLA.
Predicate Device:	DePuy Synthes TransTend Anchors (K102298)
Reference Devices:	DePuy Synthes Healix Advance with DYNA+TAPE (K191483)Parcus Medical, LLC Parcus MiTi Suture Anchor (K201083)Paragon 28, Inc. Paratrooper Plantar Plate Repair System (K191227)Riverpoint HS Suture Tape (K153307)Riverpoint Polyblend Non-Absorbable Surgical Suture (K100006,K190817)Ethicon VICRYL Polyglactin 910 Sterile Synthetic AbsorbableSurgical Suture (K183183)Paragon 28 Grappler Interference Screw (K183690)Paragon 28 TenoTac Soft Tissue Fixation Device (K182898)Riverpoint PGLA Absorbable Suture (K120556)DePuy Mitek ORTHOCORD (K123668)
SubstantialEquivalence:	The GRAPPLER™ Suture Anchor System is substantiallyequivalent to the legally marketed predicate device systems withrespect to intended use and design. The subject system shares thesame materials, features, and intended use. Differences in design,sizing, and manufacturing were shown not to introduce newquestions of safety and effectiveness.
	device performs as intended. All testing was performed on finished devices. The device performance was characterized via torsional strength, insertion/removal torque, pullout testing and tensile testing. Device shelf life was validated through real time and accelerate aging events assessed with seal strength, visual inspection, dye penetration, pressurization evaluations. Device sterility was validated through bioburden testing. Pyrogenicity was verified through bacterial endotoxin (LAL) testing. Clinical data are not needed to support the safety and effectiveness of the subject device.
Conclusions:	The GRAPPLER™ Suture Anchor System subject to this submission possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the GRAPPLER™ Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the GRAPPLER™ Suture Anchor System components are substantially equivalent to the predicate devices for the intended use.

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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.