(56 days)
No
The summary describes a mechanical suture anchor system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is a suture anchor system intended for the fixation of soft tissue to bone, which is a therapeutic intervention for various injuries and conditions across multiple anatomical sites.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states that the GRAPPLER Suture Anchor System is "intended for the fixation of soft tissue to bone." This describes a therapeutic or reparative function, not a diagnostic one. Diagnostic devices are used to identify a condition or disease, while this device performs a physical repair.
No
The device description explicitly states that the system consists of suture anchors, suture, and 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 during surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device consists of suture anchors, suture, and instrumentation for surgical repair. These are all components used in vivo (within the body) during surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties (torsional yield, pullout strength, fatigue), material properties, and sterility – all relevant to a surgical implant, not an IVD.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
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, 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 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
Prescription Use
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 necessary testing has been performed on representative GRAPPLER Suture Anchor System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices. Testing included Torsional Yield per ASTM F543, Insertion and Removal Torque per ASTM F543, Pullout Strength per ASTM F543, an analysis for Suture Abrasion, a USP Monograph including USP and USP , 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 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.
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
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
1
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
2
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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3
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-Spicer |
| Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 585-455-2810 | |
| ewspicer@paragon28.com | |
| Date Prepared: | August 7, 2023 |
| 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. |
4
| | K231867
Page 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, 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 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: | Grappler Suture Anchor System (K211002) |
| Reference Device: | Parcus Medical, LLC Parcus MiTi Suture Anchor (K201083) |
| 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 differences in
technological characteristics between the subject device and
predicate device are an updated driver and anchor interface,
and increased material around the suture eyelet. Differences
in design were shown not to introduce new questions of safety
and effectiveness. |
| Performance Testing: | All necessary testing has been performed on representative
GRAPPLER Suture Anchor System components to assure
substantial equivalence to its predicate and demonstrate the
subject device performs as intended. All testing was
performed on finished devices. Testing included Torsional
Yield per ASTM F543, Insertion and Removal Torque per |
5
K231867 Page 3 of 3
ASTM F543, Pullout Strength per ASTM F543, an analysis for Suture Abrasion, a USP Monograph including USP and USP , 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.