The GRYPHON X Anchor is intended for:
Shoulder: Biceps Tenodesis;
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, Medial Patellofemoral Ligament Reconstruction;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction

The HEALIX TRANSTEND Anchor is intended for:
Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis;
Elbow: Lateral Epicondylitis Repair;
Wrist: Scapholunate Ligament Reconstruction;
Hip: Capsular Repair, Acetabular Labral Repair

Device Description

The subject devices of this Traditional 510(k) are the GRYPHON X Anchors and the HEALIX TRANSTEND Anchors.

The proposed GRYPHON X Anchor is suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture to bone for various orthopedic procedures. The proposed anchor will be available with various suture offerings: ORTHOCORD™ Suture, PERMACORD™ Suture, DYNACORD™ Suture, and PERMATAPE™ 1.3mm Suture, offered in either single strand or double strand configurations with needle attachments. The GRYPHON X Anchors are offered with either a push-in (“P”) or threaded (“T”) anchor design and are available in absorbable BIOCRYL RAPIDE (BR) (P and T anchors) or non-absorbable PEEK materials (P anchors only). The implant is supplied sterile, ready to use.

The proposed HEALIX TRANSTEND Anchor is a suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture bone for various orthopedic procedures. This proposed device will be loaded with either one or two strands of PERMATAPE 1.3mm Suture and will be offered in PEEK material only. The implant is supplied sterile ready to use.

The proposed GRYPHON X product portfolio also contains a reusable instrument sterilization tray with lid (sold separately) – it's intended to store and protect the reusable instruments during transport and sterilization

AI/ML Overview

This document is an FDA 510(k) Premarket Notification for orthopedic bone fixation devices (suture anchors). It details the substantial equivalence of the GRYPHON™ X Anchor and HEALIX TRANSTEND™ Anchor to existing predicate devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Preamble: The document states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices. This means that, for the purpose of this FDA clearance, the new devices (GRYPHON X and HEALIX TRANSTEND anchors) are considered as safe and effective as the already-marketed predicate devices. The basis for this determination is laid out in the acceptance criteria and non-clinical testing section below.

Regarding the specific requirements for "device meets the acceptance criteria" as requested in your prompt, it's important to understand that for a 510(k) submission like this, the "acceptance criteria" are primarily defined by:

Substantial Equivalence: Demonstrating that the new device has the same intended use and similar technological characteristics as a predicate device, or that any differences do not raise new questions of safety or effectiveness.
Performance Testing: Providing data from non-clinical (and sometimes clinical, though not typically required for Class II 510(k)s unless new questions of safety/effectiveness are raised) tests to support the substantial equivalence claim.

Therefore, the "acceptance criteria" table below will reflect the comparative aspects and performance tests mentioned in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from 510(k) requirements and established by predicates)	Reported Device Performance (from "Non-clinical Testing" and "Safety and Performance" sections)
Technological Characteristics - Similarity to Predicate:- Anchor design- Materials- Principle of operation- Intended use	The anchor design, materials, principle of operation, and intended use of the subject devices are identical to that of the predicate devices. The main differences are additional suture configurations and additional indications for use (GRYPHON X only), which are addressed by the non-clinical testing.
Performance - Fixation Strength:- At T=0 (initial fixation)- Over healing period (for absorbable materials)	Verification activities included an assessment of fixation strength for proposed indications at T=0 and over the healing period (for absorbable configuration). The results demonstrated that the devices continue to meet established design inputs and corresponding criteria.
Performance - Insertion Force	Verification activities included an assessment of insertion force. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria.
Performance - Fatigue Strength	Verification activities included an assessment of fatigue strength. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria.
Performance - Needle Attachment Strength (for pre-loaded sutures)	Verification activities included an assessment of needle attachment strength for the pre-loaded sutures in scope of the submission. The results demonstrated that the devices continue to meet established design inputs and corresponding criteria.
Overall Safety and Effectiveness - No New Issues	Results of the analyses demonstrated that there were no new issues of safety or effectiveness related to device performance.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes used for the non-clinical testing (e.g., number of anchors tested for fixation strength, insertion force, etc.). It generally refers to "verification activities" and "analyses" demonstrating that the devices meet criteria.
The data provenance is non-clinical testing, performed to support product safety and performance, typically done in vitro (bench testing). The document does not provide details on the location/country of origin of this data or if it's retrospective or prospective, but for 510(k) non-clinical testing, it is always prospective, often conducted by the manufacturer or a contract research organization.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For this type of 510(k) submission, there isn't a "ground truth" derived from expert clinical assessment in the same way as, for example, an AI/imaging device. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices.
Expert involvement for establishing ground truth (e.g., radiologists for imaging studies) is not applicable or described in this document for these mechanical orthopedic implants. The "experts" involved are likely engineers, material scientists, and regulatory affairs professionals who conducted and reviewed the bench testing against predefined engineering specifications and regulatory standards. Their specific number or qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

Since this is primarily non-clinical, bench testing, adjudication methods (like 2+1, 3+1 concensus for clinical interpretations) are not applicable. The device performance is measured against engineering specifications and industry standards for mechanical properties.
Any "adjudication" would involve internal quality control and regulatory review processes, rather than interpretation of clinical data by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those that involve human interpretation of images (e.g., AI in radiology).
The devices in this submission are mechanical orthopedic implants (suture anchors). Their effectiveness is proven through biomechanical testing (fixation strength, fatigue, etc.) and by demonstrating substantial equivalence to currently marketed devices, not through human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This question pertains to AI/software devices. The devices submitted are physical medical implants (suture anchors), not algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly established by engineering specifications, industry standards relevant to orthopedic implants, and the performance characteristics of the identified predicate devices.
The tests performed (fixation strength, fatigue strength, insertion force, needle attachment strength) are benchmarked against what is considered acceptable for such devices on the market. The statement "Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria" confirms this.
There's no mention of pathology, outcomes data, or expert consensus in a clinical diagnostic sense being used as ground truth for this mechanical device.

8. The Sample Size for the Training Set

Not applicable. This question is typically relevant for machine learning or AI models, which require training data. The devices in this submission are mechanical orthopedic implants. They do not involve "training sets" in the computational sense.

9. How the Ground Truth for the Training Set was Established

Not applicable. As explained in point 8, there is no "training set" for these mechanical devices.

Summary

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February 5, 2025

Image /page/0/Picture/1 description: The image contains 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.

DePuy Mitek Ashley Aromando Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K243790

Trade/Device Name: GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor 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: December 9, 2024 Received: December 10, 2024

Dear Ashley Aromando:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, MS Assistant Director, Biomedical Engineer 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

Submission Number (if known)

K243790

Device Name

GRYPHON™ X Anchor;

HEALIX TRANSTEND™ Anchor

Indications for Use (Describe)

The GRYPHON X Anchor is intended for:

Shoulder: Biceps Tenodesis;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique

Ligament Repair, Illiotibial Band Tenodesis, Medial Patellofemoral Ligament Reconstruction;

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

The HEALIX TRANSTEND Anchor is intended for:

Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis, Acromio-Clavicular Separation, Deltoid Repair;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-Foot Reconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique

Ligament Repair, Iliotibial Band Tenodesis;

Elbow: Lateral Epicondylitis Repair;
Wrist: Scapholunate Ligament Reconstruction;
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)

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510(k) Summary

GRYPHON™ X Anchors, HEALIX TRANSTEND™ Anchors

Date Prepared: 02/04/2025

Submitter'sName andAddress	DePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767On behalf of:Medos International SARLChemin-Blanc 38, Le Locle NeuchatelCH 2400, Switzerland
Contact Person	Ashley AromandoManager, Regulatory AffairsDePuy Synthes Mitek Sports Medicinea Johnson & Johnson company325 Paramount DriveRaynham, MA 02767	Telephone: 508-977-3907Email: aaromand@its.jnj.com
Name of MedicalDevice	Proprietary Name:A) GRYPHON™ X AnchorB) HEALIX TRANSTEND™ AnchorClassification Name:A) MAI, MBIB) MBIRegulation Description:A) Single/multiple component metallic bone fixation appliances and accessories;Smooth or threaded metallic bone fixation fastenerB) Single/multiple component metallic bone fixation appliances and accessoriesCommon Name:A) Suture AnchorB) Suture Anchor
SubstantialEquivalence	The GRYPHON X Anchors are substantially equivalent to the following predicateand reference devices:Primary Predicate Device:
• K073412 GRYPHON BR Anchors with ORTHOCORD Suture
Additional Predicate Device:
• K090124 GRYPHON BR Anchors with ORTHOCORD Suture
Reference Device(s):
• K103712 GRYPHON PEEK Anchors with ORTHOCORD Suture
• K141259 GRYPHON Anchors with PERMACORD Suture
• K181809 GRYPHON Anchors with DYNACORD Suture
The HEALIX TRANSTEND Anchors are substantially equivalent to the following predicate:
Primary Predicate Device:
• K102298 HEALIX TRANSTEND Anchors
Device Classification	The GRYPHON X Anchors are classified as:
	• Smooth or threaded metallic bone fixation fasteners, classified as Class II, product code MBI, regulated under 21 CFR 888.3040; and
	• Single/multiple component metallic bone fixation appliances and accessories, classified as Class II, product code MAI, regulated under 21 CFR 888.3030.
	The HEALIX TRANSTEND Anchors are classified as:
	• Smooth or threaded metallic bone fixation fasteners, classified as Class II, product code MBI, regulated under 21 CFR 888.3040; and
Device Panel	Orthopedic Devices
Device Description	The subject devices of this Traditional 510(k) are the GRYPHON X Anchors and the HEALIX TRANSTEND Anchors.The proposed GRYPHON X Anchor is suture anchor preloaded on a disposable inserter assembly and is intended for fixation of suture to bone for various orthopedic procedures. The proposed anchor will be available with various suture offerings: ORTHOCORD™ Suture, PERMACORD™ Suture, DYNACORD™ Suture, and PERMATAPE™ 1.3mm Suture, offered in either single strand or double strand configurations with needle attachments. The GRYPHON X Anchors are offered with either a push-in (“P”) or threaded (“T”) anchor design and are available in absorbable BIOCRYL RAPIDE (BR) (P and T anchors) or non-absorbable PEEK materials (P anchors only). The implant is supplied sterile, ready to use.
The proposed HEALIX TRANSTEND Anchor is a suture anchor preloaded on adisposable inserter assembly and is intended for fixation of suture bone for variousorthopedic procedures. This proposed device will be loaded with either one ortwo strands of PERMATAPE 1.3mm Suture and will be offered in PEEK materialonly. The implant is supplied sterile ready to use.
The proposed GRYPHON X product portfolio also contains a reusable instrumentsterilization tray with lid (sold separately) – it's intended to store and protect thereusable instruments during transport and sterilization
TechnologicalCharacteristics	The anchor design, materials, principal of operation, and intended use of thesubject devices are identical to that of the predicate devices. The main differencesbetween the proposed devices and predicate devices are the additional sutureconfigurations and additional indications for use (GRYPHON X only).
Indications forUse	The GRYPHON X Anchor is intended for:Shoulder: Biceps Tenodesis; 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, MedialPatellofemoral Ligament Reconstruction; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction
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--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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The HEALIX TRANSTEND Anchor is intended for:	Shoulder: Rotator Cuff, Partial Thickness Rotator Cuff, Biceps Tenodesis,Acromio-Clavicular Separation, Deltoid Repair; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Mid-FootReconstruction, Hallux Valgus Repair, Metatarsal Ligament/Tendon Repairs; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Lateral Epicondylitis Repair; Wrist: Scapholunate Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair
Non-clinicalTesting	Verification activities were assessed for the proposed devices. Verificationincluded an assessment of fixation strength for proposed indications at T=0 andover the healing period (absorbable configuration), insertion force, fatigue strength,as well as an assessment of needle attachment strength for the pre-loaded sutures inscope of the submission.
Safety andPerformance	Results of the analyses demonstrated that the devices continue to meet establisheddesign inputs and corresponding criteria, and that there were no new issues ofsafety or effectiveness related to device performance.
	Based on similarities in the intended use, technological characteristics, andperformance in comparison to the predicate devices, the proposed GRYPHON XAnchors and HEALIX TRANSTEND Anchors have shown to be substantiallyequivalent to the predicate devices under the Federal Food, Drug and CosmeticAct.

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Johnson & Johnson Med Tech

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.