Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular Repair, Acetabular Labral Repair

The GRYPHON® PEEK Anchor with DYNACORD™ Suture is intended for:

Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Elbow: Ulnar or Radial Collateral Ligament Reconstruction

Hip: Capsular Repair, Acetabular Labral Repair.

Device Description

The GRYPHON® Anchor with DYNACORD™ Suture is a push-in suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The GRYPHON® Anchors with DYNACORD™ Suture are available in absorbable BR and non-absorbable PEEK materials. The GRYPHON® Anchors with DYNACORD™ is provided sterile and is for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for the GRYPHON® Anchors with DYNACORD™ Suture. It establishes substantial equivalence to previously marketed predicate devices and does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and studies proving device performance with an AI component cannot be extracted.

However, I can provide the available information from the document related to general non-clinical testing performed on the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Performance testing included anchor fixation testing and in-vitro testing." However, specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons, or maximum displacement) and the exact reported performance values are not provided in this summary.

Acceptance Criteria Category	Acceptance Criteria (Not Specified)	Reported Device Performance (Not Specified)
Anchor Fixation Testing	Not explicitly stated (e.g., minimum pull-out strength, maximum displacement)	The document states "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." Specific values not provided.
In-vitro Testing	Not explicitly stated	The document states "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use." Specific values not provided.
Sterility	Meets sterility requirements	"Safety evaluations were conducted to address sterility..." The implication is that it met the criteria.
Packaging	Meets packaging requirements	"Safety evaluations were conducted to address packaging..." The implication is that it met the criteria.
Shelf-life Testing	Meets shelf-life requirements	"Safety evaluations were conducted to address ... shelf-life testing." The implication is that it met the criteria.
Bacterial Endotoxin	Meets endotoxin limits	"Bacterial endotoxin testing has been completed on representative device and results have demonstrated that the proposed devices meet the endotoxin limits."

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided in the document, as it pertains to an AI/algorithmic study, which is not described here. The non-clinical testing likely refers to engineering and biocompatibility tests, not clinical data sets.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/provided, as no AI/algorithmic ground truth establishment is described.

4. Adjudication Method:

This information is not applicable/provided, as no AI/algorithmic study with adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. This document describes a medical device (suture anchors), not an AI-assisted diagnostic or treatment planning tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable/provided, as the device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used:

For the non-clinical testing mentioned, the "ground truth" would be established by engineering specifications, material science standards, and biological safety standards (e.g., pass/fail criteria for pull-out strength, acceptable levels of endotoxins). It does not involve "expert consensus, pathology, or outcomes data" in the typical sense of AI studies.

8. Sample Size for the Training Set:

This information is not applicable/provided, as no AI model or training set is described.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/provided, as no AI model or training set is described.

Summary

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August 3, 2018

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Medos International SARL % Tatyana Korsunsky Regulatory Affairs Technical Manager DePuy Mitek, a Johnson & Johnson company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K181809

Trade/Device Name: GRYPHON® Anchors with DYNACORD™ Suture Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: July 3, 2018 Received: July 6, 2018

Dear Ms. Korsunsky:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sarah B. Nelson -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181809

Device Name

GRYPHON® Anchors with DYNACORD™ Suture

Indications for Use (Describe)

The GRYPHON® BR Anchor with DYNACORD™ Suture is intended for:

Shoulder:	Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle:	Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee:	Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique LigamentRepair, Iliotibial Band Tenodesis
Elbow:	Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip:	Capsular Repair, Acetabular Labral Repair

The GRYPHON® PEEK Anchor with DYNACORD™ Suture is intended for:

Shoulder:	Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, DeltoidRepair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle:	Lateral Stabilization, Medial Stabilization
Knee:	Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique LigamentRepair, Iliotibial Band Tenodesis
Elbow:	Ulnar or Radial Collateral Ligament Reconstruction
Hip:	Capsular Repair, Acetabular Labral Repair

Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

GRYPHON® Anchors with DYNACORD™ Suture

510k Document Number: K181809

Date Prepared: July 30th, 2018

Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Tatyana KorsunskyRegulatory Affairs Technical ManagerDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3122e-mail: tkorsuns@its.jnj.com
Name ofMedical Device	Proprietary Name: GRYPHON® Anchor with DYNACORD™ Suture:a) GRYPHON® BR Anchor with DYNACORD™ Sutureb) GRYPHON® PEEK Anchor with DYNACORD™ SutureClassification Name: a) Single/multiple component metallic bone fixationappliances and accessoriesb) Smooth or threaded metallic bone fixation fastenersCommon Name: Suture Anchor
SubstantialEquivalence	The GRYPHON® Anchors with DYNACORD™ Suture are substantially equivalentto:K141259 GRYPHON® Anchors with PERMACORD™ Suture Reference devices: K173859 HEALIX ADVANCE™ Anchors with DYNACORD™ Suture
DeviceClassification	> GRYPHON® BR Anchor with DYNACORD™ Suture is classified as:Single/multiple component metallic bone fixation appliances and accessories,classified as Class II, product code MAI, regulated under 21 CFR 888.3030.> GRYPHON® PEEK Anchor with DYNACORD™ Suture is classified as:Smooth or threaded metallic bone fixation fasteners, classified as Class II,product code MBI, regulated under 21 CFR 888.3040
DeviceDescription	The GRYPHON® Anchor with DYNACORD™ Suture is a push-in suture anchorpreloaded on a disposable inserter assembly intended for fixation of soft tissue tobone. The GRYPHON® Anchors with DYNACORD™ Suture are available inabsorbable BR and non-absorbable PEEK materials. The GRYPHON® Anchors withDYNACORD™ is provided sterile and is for single use only.
TechnologicalCharacteristics	The proposed GRYPHON® Anchors with DYNACORD™ Suture has the sameanchor materials, design, principle of operation, as well as device assembly,sterilization method, and shelf life, as predicate GRYPHON® Anchors withPERMACORD™ Suture (K141259). The DYNACORD™ Suture component is anon-absorbable suture that conforms to USP, except for oversized diameter. TheDYNACORD™ Suture is designed to resist laxity and minimize gap formation, bymaintaining approximation force (compression). DYNACORD™ Suture on theGRYPHON® Anchors is the same as the DYNACORD™ Suture on referencepredicate HEALIX ADVANCE™ Anchors with DYNACORD™ Suture(K173859).
Indications forUse	GRYPHON® BR Anchors with DYNACORD™ Suture are indicated for:Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift orCapsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon RepairKnee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Posterior Oblique Ligament Repair, Iliotibial Band TenodesisElbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstructionHip: Capsular Repair, Acetabular Labral RepairGRYPHON® PEEK Anchors with DYNACORD™ Suture are indicated for:Shoulder: Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or CapsulolabralReconstructionFoot/Ankle: Lateral Stabilization, Medial StabilizationKnee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Posterior Oblique Ligament Repair, Iliotibial Band TenodesisElbow: Ulnar or Radial Collateral Ligament ReconstructionHip: Capsular Repair, Acetabular Labral Repair.

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Non clinicalTesting	Non-clinical testing has been performed on the proposed device and / or itspredicates. Performance testing included anchor fixation testing and in-vitro testing.Safety evaluations were conducted to address sterility, packaging, shelf-life testing.Bacterial endotoxin testing has been completed on representative device and resultshave demonstrated that the proposed devices meet the endotoxin limits.
Safety andPerformance	Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use. Based on similarities in the indications for use,technological characteristics, and performance in comparison to the predicatedevices, the proposed GRYPHON® Anchors with DYNACORD™ Suture has shownto be substantially equivalent to the predicate devices under the Federal Food, Drugand Cosmetic Act.

Non clinicalTesting

Non-clinical testing has been performed on the proposed device and / or itspredicates. Performance testing included anchor fixation testing and in-vitro testing.Safety evaluations were conducted to address sterility, packaging, shelf-life testing.Bacterial endotoxin testing has been completed on representative device and resultshave demonstrated that the proposed devices meet the endotoxin limits.

Safety andPerformance

Results of performance testing have demonstrated that the proposed devices aresuitable for their intended use. Based on similarities in the indications for use,technological characteristics, and performance in comparison to the predicatedevices, the proposed GRYPHON® Anchors with DYNACORD™ Suture has shownto be substantially equivalent to the predicate devices under the Federal Food, Drugand Cosmetic Act.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.