(61 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is described as the Grappler Suture Anchor System for the fixation of soft tissue to bone for various repairs in different anatomical sites, which clearly indicates its use in treating medical conditions.
No
The device is described as a "Suture Anchor System" intended for "fixation of soft tissue to bone," which is a surgical repair function, not a diagnostic one.
No
The device description explicitly states the system consists of suture anchors, suture, and accompanying instrumentation, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of soft tissue to bone in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of suture anchors, suture, and instrumentation. These are all physical components used in a surgical setting.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with bodily specimens for diagnostic purposes.
The device is a surgical implant and associated tools, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / 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, 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.
Product codes
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow, Shoulder, Hand/Wrist, Foot/Ankle, Knee, Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices. Bacterial endotoxin testing was conducted and the test results meet acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Grappler Suture Anchor System (K211002)
Reference Device(s)
Baby Gorilla®/Gorilla® Plating System (K221465), R3ACT Stabilization System (K211770)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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)
| ☑ 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 Hertz |
| Sr. Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 303-720-0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | September 14, 2022 |
| 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. | |
| 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 titanium and are accompanied | |
| by suture tape composed of UHMWPE. | |
| Predicate Device: | Grappler Suture Anchor System (K211002) |
| Reference Devices: | Baby Gorilla®/Gorilla® Plating System (K221465) |
| R3ACT Stabilization System (K211770) | |
| Substantial | |
| Equivalence: | The proposed Grappler Suture Anchor System are substantially equivalent |
| to the predicate Grappler Suture Anchor System (K211002) 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. The results of the analysis | |
| demonstrated the modified designs are substantially equivalent to the | |
| predicate devices. Bacterial endotoxin testing was conducted and the test | |
| results meet acceptance criteria. | |
| Conclusions: | The Grappler Suture Anchor System subject to this submission possesses |
| the same intended use and has similar technological characteristics as the | |
| predicate device system components. Differences between the Grappler | |
| Suture Anchor System and the predicate device were not shown to raise | |
| new questions of safety and effectiveness (i.e anchor diameter, dynamic | |
| technology, plate interacting technology). 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. |
4