Who is the manufacturer of Grappler Suture Anchor R3FLEX IOL System?

Paragon 28, Inc. filed the 510(k) submission for Grappler Suture Anchor R3FLEX IOL System (K223589).

What is the FDA product code for Grappler Suture Anchor R3FLEX IOL System?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Grappler Suture Anchor R3FLEX IOL System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Grappler Suture Anchor R3FLEX IOL System?

Grappler Suture Anchor System (K222091); Grappler Suture Anchor System (K211002); R3ACT Stabilization System (K211770).

Who can help prepare an FDA 510(k) submission like Grappler Suture Anchor R3FLEX IOL System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Grappler Suture Anchor R3FLEX IOL System

K223589 · Paragon 28, Inc. · MBI · Mar 3, 2023 · Orthopedic

Device Facts

Record ID	K223589
Device Name	Grappler Suture Anchor R3FLEX IOL System
Applicant	Paragon 28, Inc.
Product Code	MBI · Orthopedic
Decision Date	Mar 3, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Grappler Suture Anchor R3FLEX IOL 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 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 Story

System comprises suture anchors, suture, and instrumentation for soft tissue-to-bone fixation; anchors available in titanium and all-suture configurations; connected by UHMWPE suture. Used by surgeons in clinical settings for orthopedic repairs (e.g., rotator cuff, ligament reconstruction). Device facilitates mechanical attachment of soft tissue to bone, aiding healing and stabilization. No AI/ML or software components.

Clinical Evidence

Bench testing only. Engineering analysis provided for suture abrasion, dynamic axial dissociation, and USP monograph compliance. Bacterial endotoxin testing met FDA-recognized standard acceptance criteria.

Technological Characteristics

Materials: Titanium and all-suture anchors; UHMWPE suture. Mechanical fixation principle. No software, energy source, or connectivity.

Indications for Use

Indicated for fixation of soft tissue to bone in elbow, shoulder, hand/wrist, foot/ankle, knee, and hip procedures. Plate interacting anchors limited to hand/wrist and foot/ankle indications.

Regulatory Classification

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.

Predicate Devices

Grappler Suture Anchor System (K222091)
Grappler Suture Anchor System (K211002)
R3ACT Stabilization System (K211770)

Reference Devices

Baby Gorilla®/Gorilla® Plating System (K222194)

Related Devices

K240594 — Grappler Suture Anchor R3FLEX IOL System · Paragon 28, Inc. · Mar 26, 2024
K142230 — Apollo Suture Anchor System and Titan Screws · Valeris Medical · Sep 10, 2014
K201636 — Hercules Suture Anchor System · In2bones USA, LLC · Aug 20, 2020
K222161 — Arthrex Knotless FiberTak Biceps Suture Anchor · Arthrex, Inc. · Aug 11, 2022
K222091 — Grappler Suture Anchor System · Paragon 28, Inc. · Sep 14, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 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. March 3, 2023 Paragon 28, Inc. Haylie Hertz Sr. Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112 Re: K223589 Trade/Device Name: Grappler Suture Anchor R3FLEX IOL System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 1, 2023 Received: February 2, 2023 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 {1}------------------------------------------------ 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 (OS) 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, ## Melissa A. Ramcharan -S 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K223589 Device Name Grappler Suture Anchor R3FLEX IOL System Indications for Use (Describe) The Grappler Suture Anchor R3FLEX IOL 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 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 | Manufacturer: | Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Haylie Hertz Sr. Regulatory Affairs Specialist Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 Phone: 303-720-0017 hhertz@paragon28.com | | Date Prepared: | March 3, 2023 | | Device Trade Name: | Grappler Suture Anchor R3FLEX IOL System | | Device Class and Common 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 R3FLEX IOL 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. 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 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 R3FLEX IOL 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 all-suture and are connected by suture composed of UHMWPE. | | Predicate Device: | Grappler Suture Anchor System (K222091, K211002) | | Additional Predicate Device: | R3ACT Stabilization System (K211770) | | Reference Devices: | Baby Gorilla®/Gorilla® Plating System (K222194), | | Substantial Equivalence: | The proposed Grappler Suture Anchor R3FLEX IOL System are substantially equivalent to the predicate Grappler Suture Anchor System (K222091) with respect to indications, design, material and function. | | Performance Testing: | Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. Specifically, an analysis was presented for Suture Abrasion, Dynamic Axial Dissociation Testing and a USP Monograph. The results of this testing demonstrate the subject device is substantially equivalent to the predicate devices. Bacterial endotoxin testing was conducted and the test results meet acceptance criteria of FDA recognized standards. | {4}------------------------------------------------ {5}------------------------------------------------ - The Grappler Suture Anchor R3FLEX IOL System subject to Conclusions: this submission possesses the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the Grappler Suture Anchor R3FLEX IOL System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the Grappler Suture Anchor R3FLEX IOL System components are substantially equivalent to the predicate devices for the intended use.