(96 days)
No
The device description and performance studies focus on the mechanical properties and sterility of the suture anchor system, with no mention of AI or ML.
Yes.
Explanation: The device is intended for the fixation of soft tissue to bone for various repairs (e.g., rotator cuff repair, Achilles tendon repair), and includes suture anchors and sutures, which are used to treat injuries or conditions.
No
Explanation: The device is a suture anchor system intended for the fixation and repair of soft tissue to bone, which is a therapeutic rather than a diagnostic function. It does not mention any diagnostic capabilities or image processing.
No
The device description explicitly states the system consists of suture anchors, suture, and accompanying instrumentation, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details suture anchors, suture, and instrumentation used for surgical repair. These are physical implants and tools used during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The information provided describes a surgical implant system, not a diagnostic test performed on biological samples.
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, 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
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K191483, K201083, K191227, K153307, K100006, K190817, K183183, K183690, K182898, K120556, K123668
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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,
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) | |
|---|---|
| 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.
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510(k) Number: K211002 Dated: June 23, 2021
510(K) SUMMARY
| 510(k) Number: | K211002 |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Haylie Hertz |
| Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 303-720-0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | June 23, 2021 |
| 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. |
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| | Foot/Ankle: Lateral Stabilization (Brostrom, 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 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 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. |
| Predicate Device: | 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) |
| Substantial
Equivalence: | The GRAPPLER™ Suture Anchor System is substantially
equivalent to the legally marketed predicate device systems with
respect to intended use and design. The subject system shares the
same materials, features, and intended use. Differences in design,
sizing, and manufacturing were shown not to introduce new
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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