(56 days)
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.
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.
The provided text appears to be an FDA 510(k) summary for a medical device called the "GRAPPLER Suture Anchor System." It outlines the device's intended use, description, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.
However, the provided document does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML. It focuses on a mechanical medical device (suture anchor system) and its physical and mechanical properties.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device, a comparative effectiveness study with human readers, or details regarding training/test sets for an AI model, as this information is not present in the provided text.
The document discusses performance testing for a physical device, which includes:
- Torsional Yield per ASTM F543
- Insertion and Removal Torque per ASTM F543
- Pullout Strength per ASTM F543
- Analysis for Suture Abrasion
- USP Monograph (including USP <861> and USP <881>)
- Suture Tape Relaxation Evaluation
- Fatigue Testing according to FDA Guidance Bone Anchors - Premarket Notification (510(k)) Submissions
- Device shelf life validation (seal strength, visual inspection, dye penetration, pressurization evaluations)
- Device sterility validation (bioburden testing)
- Pyrogenicity verification (bacterial endotoxin (LAL) testing)
The document states that "All performance testing conducted for the GRAPPLER Suture Anchor System met the predetermined acceptance criteria or were otherwise considered acceptable." However, it does not detail what those specific numerical acceptance criteria were for each test.
To summarize, based solely on the provided text, I cannot answer your request as it pertains to an AI/ML device. The document describes a traditional medical device submission.
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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
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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,
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
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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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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-SpicerRegulatory Affairs SpecialistParagon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112Phone: 585-455-2810ewspicer@paragon28.com |
| Date Prepared: | August 7, 2023 |
| Device Trade Name: | GRAPPLER Suture Anchor System |
| Device Class andCommon Name: | Class II, Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification: | 21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener |
| Product Codes: | MBI |
| Indications for Use: | The GRAPPLER Suture Anchor System is intended for thefixation of soft tissue to bone including: |
| Elbow: Biceps Tendon Reattachment, Lateral EpicondylitisRepair, Tennis Elbow Repair | |
| Shoulder: Rotator Cuff Repair, Bankart Repair, SLAPLesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Repair | |
| Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnaror Radial Collateral Ligament Reconstruction, TFCC. |
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| K231867Page 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, DigitalTendon Transfers, Mid-foot Reconstruction, LisFrancRepair | |
| Knee: Medial Collateral Ligament Repair, Lateral CollateralLigament 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 aboveHand/Wrist and Foot/Ankle indications. | |
| Device Description: | The GRAPPLER Suture Anchor System consists of sutureanchors, suture, and the accompanying instrumentation forthe intended use of soft tissue damage repair. The anchors areprovided in PEEK, titanium, and suture materials in multiplesizes and lengths. Each anchor is accompanied by roundsuture 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) |
| SubstantialEquivalence: | The GRAPPLER Suture Anchor System is substantiallyequivalent to the legally marketed predicate device systemswith respect to intended use and design. The differences intechnological characteristics between the subject device andpredicate device are an updated driver and anchor interface,and increased material around the suture eyelet. Differencesin design were shown not to introduce new questions of safetyand effectiveness. |
| Performance Testing: | All necessary testing has been performed on representativeGRAPPLER Suture Anchor System components to assuresubstantial equivalence to its predicate and demonstrate thesubject device performs as intended. All testing wasperformed on finished devices. Testing included TorsionalYield per ASTM F543, Insertion and Removal Torque per |
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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.
§ 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.