Who is the manufacturer of Grappler Suture Anchor System?

Paragon 28, Inc. filed the 510(k) submission for Grappler Suture Anchor System (K231867).

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

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

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

Q: What are the predicate devices for Grappler Suture Anchor System?

Grappler Suture Anchor System (K211002).

K231867 · Paragon 28, Inc. · MBI · Aug 21, 2023 · Orthopedic

Device Facts

Record ID	K231867
Device Name	Grappler Suture Anchor System
Applicant	Paragon 28, Inc.
Product Code	MBI · Orthopedic
Decision Date	Aug 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair, Metatarsal Ligament 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, Iliotilbial 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, sutures, and instrumentation for soft tissue-to-bone fixation. Anchors fabricated from PEEK or titanium; sutures/tapes from UHMWPE and PGLA. Used by surgeons in clinical settings to reattach tendons or ligaments to bone. Device provides mechanical fixation; surgeon inserts anchor into bone and secures soft tissue via attached sutures. Benefits include restoration of anatomical attachment points and stabilization of injured tissues. Updated design features modified driver-anchor interface and increased material around suture eyelet.

Clinical Evidence

Bench testing only. Testing included torsional yield, insertion/removal torque, pullout strength (ASTM F543), suture abrasion, USP monographs (<861>, <881>), suture tape relaxation, and fatigue testing per FDA guidance. Shelf life validated via real-time/accelerated aging; sterility via bioburden testing; pyrogenicity via LAL testing.

Technological Characteristics

Materials: PEEK, titanium, UHMWPE, PGLA. Mechanical fixation via suture anchors. Testing standards: ASTM F543 (torsional yield, insertion/removal torque, pullout strength), USP <861>, USP <881>. Sterilization validated via bioburden testing.

Indications for Use

Indicated for soft tissue to bone fixation in elbow, shoulder, hand/wrist, foot/ankle, knee, and hip procedures. Prescription use only.

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 (K211002)

Reference Devices

Parcus Medical, LLC Parcus MiTi Suture Anchor (K201083)

Related Devices

K211002 — Grappler Suture Anchor System · Paragon 28, Inc. · Jul 7, 2021
K120824 — 3.9MM REELX STT SUTURE ANCHOR SYSTEM · Stryker Corp. · Jul 18, 2012
K181076 — Responsive Arthroscopy Wedge Push-In Suture Anchors · Responsive Arthroscopy, LLC · Jan 18, 2019
K190446 — Responsive Arthroscopy Wedge Push-In Suture Anchors · Responsive Arthroscopy, LLC · Mar 27, 2019
K251530 — CONMED Argo Knotless® Anchor · Conmed Corporation · Jun 18, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ August 21, 2023 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration". Paragon 28, Inc. Edward Wells-Spicer Regulatory Affairs Specialist 14445 Grasslands Dr Englewood, Colorado 80112 Re: K231867 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, 2023 Received: June 26, 2023 Dear Edward Wells-Spicer: 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 avare 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, Jesse Muir -S Jesse Muir, 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) K231867 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 Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair, Metatarsal Ligament 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}------------------------------------------------ # K231867 Page 1 of 3 ## 510(K) SUMMARY | 510(k): | K231867 | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 | | Contact: | Edward (E.J.) Wells-Spicer Regulatory Affairs Specialist Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 Phone: 585-455-2810 ewspicer@paragon28.com | | Date Prepared: | August 7, 2023 | | Device Trade Name: | GRAPPLER Suture Anchor 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 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. | {4}------------------------------------------------ | | K231867 Page 2 of 3 | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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 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. | | Predicate Device: | Grappler Suture Anchor System (K211002) | | Reference Device: | Parcus Medical, LLC Parcus MiTi Suture Anchor (K201083) | | Substantial Equivalence: | The GRAPPLER Suture Anchor System is substantially equivalent to the legally marketed predicate device systems with respect to intended use and design. The differences in technological characteristics between the subject device and predicate device are an updated driver and anchor interface, and increased material around the suture eyelet. Differences in design were shown not to introduce new questions of safety and effectiveness. | | Performance Testing: | All necessary testing has been performed on representative GRAPPLER Suture Anchor System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices. Testing included Torsional Yield per ASTM F543, Insertion and Removal Torque per | {5}------------------------------------------------ #### K231867 Page 3 of 3 ASTM F543, Pullout Strength per ASTM F543, an analysis for Suture Abrasion, a USP Monograph including USP <861> and USP <881>, a Suture Tape Relaxation Evaluation and Fatigue Testing according to FDA Guidance Bone Anchors -Premarket Notification (510(k)) Submissions. Device shelf life was validated through real time and accelerated 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. The GRAPPLER Suture Anchor System subject to this Conclusions: submission possesses the same intended use and has similar 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.