Grappler Suture Anchor System

K211002 · Paragon 28, Inc. · MBI · Jul 7, 2021 · Orthopedic

Device Facts

• Record ID: K211002
• Device Name: Grappler Suture Anchor System
• Applicant: Paragon 28, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 7, 2021
• 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, 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 Story

Suture anchor system for soft tissue-to-bone fixation; includes anchors, sutures, and instrumentation. Anchors manufactured from PEEK and titanium; sutures/tapes composed of UHMWPE and PGLA. Used by surgeons in clinical settings for orthopedic repairs (e.g., rotator cuff, ligament reconstruction). Device provides mechanical fixation of soft tissue to bone to facilitate healing. Performance verified via bench testing (torsional strength, insertion/removal torque, pullout, tensile testing).

Clinical Evidence

No clinical data. Bench testing only: torsional strength, insertion/removal torque, pullout, and tensile testing. Shelf life validated via real-time and accelerated aging (seal strength, visual inspection, dye penetration, pressurization). Sterility validated via bioburden testing; pyrogenicity verified via LAL testing.

Technological Characteristics

Materials: PEEK, titanium, UHMWPE, PGLA. Mechanical fixation device. Includes anchors, sutures, and instrumentation. Sterilization: Not specified.

Indications for Use

Indicated for fixation of soft tissue to bone in elbow, shoulder, hand/wrist, foot/ankle, knee, and hip procedures requiring soft tissue repair.

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

• 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 Absorbable Surgical 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)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

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

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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

# 510(K) SUMMARY

| 510(k) Number: | K211002 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Paragon 28, Inc.<br>14445 Grasslands Dr.<br>Englewood, CO 80112 |
| Contact: | Haylie Hertz<br>Regulatory Affairs Specialist<br>Paragon 28, Inc.<br>14445 Grasslands Dr.<br>Englewood, CO 80112<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | June 23, 2021 |
| Device Trade Name: | GRAPPLER™ Suture Anchor System |
| Device Class and<br>Common Name: | Class II, Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification: | 21 CFR 888.3040: Smooth or threaded metallic bone fixation<br>fastener |
| Product Codes: | MBI |
| Indications for Use: | The GRAPPLER™ Suture Anchor System is intended for the<br>fixation of soft tissue to bone including: |
| | Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair,<br>Tennis Elbow Repair |
| | Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion<br>Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair,<br>Deltoid Repair, Capsular Shift or Capsulolabral Repair |
| | Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or<br>Radial Collateral Ligament Reconstruction, TFCC. |

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| | Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould,<br>Chrisman-Snook Repair), Ankle Ligament Repair, Medial<br>Stabilization (Deltoid Repair, Spring Ligament Reconstruction),<br>Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis<br>Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers,<br>Mid-foot Reconstruction, LisFranc Repair |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Knee: Medial Collateral Ligament Repair, Lateral Collateral<br>Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial<br>Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament<br>and Tendon Avulsion Repair |
| | Hip: Capsular Repair, Acetabular Labral Repair |
| Device Description: | The GRAPPLER™ Suture Anchor System consists of suture<br>anchors, suture, and the accompanying instrumentation for the<br>intended use of soft tissue damage repair. The anchors are provided<br>in PEEK, titanium, and suture materials in multiple sizes and lengths.<br>Each anchor is accompanied by round suture or suture tape composed<br>of UHMWPE and PGLA. |
| Predicate Device: | DePuy Synthes TransTend Anchors (K102298) |
| Reference Devices: | DePuy Synthes Healix Advance with DYNA+TAPE (K191483)<br>Parcus Medical, LLC Parcus MiTi Suture Anchor (K201083)<br>Paragon 28, Inc. Paratrooper Plantar Plate Repair System (K191227)<br>Riverpoint HS Suture Tape (K153307)<br>Riverpoint Polyblend Non-Absorbable Surgical Suture (K100006,<br>K190817)<br>Ethicon VICRYL Polyglactin 910 Sterile Synthetic Absorbable<br>Surgical Suture (K183183)<br>Paragon 28 Grappler Interference Screw (K183690)<br>Paragon 28 TenoTac Soft Tissue Fixation Device (K182898)<br>Riverpoint PGLA Absorbable Suture (K120556)<br>DePuy Mitek ORTHOCORD (K123668) |
| Substantial<br>Equivalence: | The GRAPPLER™ Suture Anchor System is substantially<br>equivalent to the legally marketed predicate device systems with<br>respect to intended use and design. The subject system shares the<br>same materials, features, and intended use. Differences in design,<br>sizing, and manufacturing were shown not to introduce new<br>questions 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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