(92 days)
No
The device description and performance studies focus on mechanical properties and material composition, with no mention of AI or ML.
Yes.
The device is intended for the fixation of soft tissue to bone for various repairs (e.g., Rotator Cuff Repair, Achilles Tendon Repair) which are therapeutic treatments for injury or disease.
No
The device is a system of suture anchors and instruments intended for the fixation of soft tissue to bone, which is a therapeutic purpose, 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 during surgical procedures to repair injuries in various anatomical locations (Elbow, Shoulder, Hand/Wrist, Foot/Ankle, Knee, Hip). This is a surgical device used directly on the patient's body.
- Device Description: The description details suture anchors, suture, and instrumentation used for soft tissue damage repair. These are physical components used in surgery.
- 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 information does not mention any interaction with bodily specimens for diagnostic purposes.
Therefore, the Grappler Suture Anchor R3FLEX IOL System is a surgical implant/device, not an IVD.
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, 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.
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, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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
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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
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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) | |
|---|---|
| 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: | 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. |
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- 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.