(22 days)
Not Found
No
The device description and intended use are purely mechanical/surgical in nature, and there is no mention of any computational or analytical capabilities that would suggest the use of AI/ML. The performance studies focus on mechanical properties and bacterial endotoxin testing.
Yes
The device is described as a "Suture Anchor R3FLEX IOL System" intended for "fixation of soft tissue to bone," which is a repair function. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a system for the fixation of soft tissue to bone, used for repair procedures, not for diagnosing conditions.
No
The device description explicitly states it consists of "suture anchors, suture, and the accompanying instrumentation," which are physical hardware components.
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 for surgical repair. These are all components used in surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / 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.
Product codes
MBI
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.
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. Specifically, an analysis was presented for Suture Abrasion and Dynamic Axial Dissociation Testing. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
March 26, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Paragon 28, Inc. Edward Wells-Spicer Regulatory Affairs Specialist II 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K240594
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: March 1, 2024 Received: March 4, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Digitally signed by Jess
Date: 2024.03.26 11:47:
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
2
Enclosure
3
Indications for Use
Submission Number (if known)
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, 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. |
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)
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510(K) SUMMARY
| Manufacturer: | Paragon 28, Inc. |
|---|---|
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Edward (E.J.) Wells-Spicer |
| Regulatory Affairs Specialist II | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 720-994-5481 | |
| ewspicer@paragon28.com | |
| Date Prepared: | March 21, 2024 |
| 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 R3FLEX IOL System (K223589) |
| Secondary Predicate | |
| Device: | Grappler Suture Anchor System (K211002) |
| Substantial | |
| Equivalence: | The Grappler Suture Anchor R3FLEX IOL System are |
| substantially equivalent to the primary predicate Grappler | |
| Suture Anchor R3FLEX IOL System (K223589) and | |
| secondary 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. Specifically, an analysis was presented for Suture | |
| Abrasion and Dynamic Axial Dissociation Testing. 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. | |
| Conclusions: | The Grappler Suture Anchor R3FLEX IOL System subject to |
| this submission possesses the same intended use and |
5
6
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.