GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor

• K Number: K243790
• Device Name: GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor
• Manufacturer: DePuy Mitek
• Date Cleared: 2025-02-05 ( 57 days)
• Product Code: MAI MBI
• Regulation Number: 888.3030

Intended Use

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

Predicate Devices

K073412, K090124, K141259, K181809, K102298

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and fixation strength of suture anchors, with no mention of AI or ML.

Therapeutic

Yes
The device is a suture anchor used for the fixation of sutures to bone in various orthopedic procedures. This directly relates to the treatment or management of injuries or conditions within the musculoskeletal system, which aligns with the definition of a therapeutic device.

Diagnostic

No
The device descriptions explicitly state that the GRYPHON X Anchor and HEALIX TRANSTEND Anchor are "suture anchors" intended for "fixation of suture to bone for various orthopedic procedures." This indicates a therapeutic or reconstructive function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states that the devices are suture anchors preloaded on a disposable inserter assembly, made of materials like BIOCRYL RAPIDE or PEEK, and supplied sterile. These are physical, hardware components, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
• Device Description: The description clearly states that the GRYPHON X and HEALIX TRANSTEND Anchors are "suture anchors preloaded on a disposable inserter assembly" intended for "fixation of suture to bone for various orthopedic procedures."
• Intended Use: The intended use lists various orthopedic procedures involving the shoulder, foot/ankle, knee, elbow, wrist, and hip. These are surgical procedures performed directly on the body, not tests on samples.

The device is an implantable medical device used in surgical procedures, not a diagnostic test performed outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

MAI, MBI

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, Foot/Ankle, Knee, Elbow, Wrist, 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)

Verification activities were assessed for the proposed devices. Verification included an assessment of fixation strength for proposed indications at T=0 and over the healing period (absorbable configuration), insertion force, fatigue strength, as well as an assessment of needle attachment strength for the pre-loaded sutures in scope of the submission.

Results of the analyses demonstrated that the devices continue to meet established design inputs and corresponding criteria, and that there were no new issues of safety or effectiveness related to device performance.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K073412, K090124, K141259, K181809, K102298

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 ([e-mail]) or phone [phone] 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

GRYPHON™ X Anchors, HEALIX TRANSTEND™ Anchors

Date Prepared: 02/04/2025

| Submitter's
Name and
Address | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767

On behalf of:
Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland | |
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| Contact Person | Ashley Aromando
Manager, Regulatory Affairs

DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | Telephone: [phone]
Email: [e-mail] |
| Name of Medical
Device | Proprietary Name:
A) GRYPHON™ X Anchor
B) HEALIX TRANSTEND™ Anchor

Classification Name:
A) MAI, MBI
B) MBI

Regulation Description:
A) Single/multiple component metallic bone fixation appliances and accessories;
Smooth or threaded metallic bone fixation fastener
B) Single/multiple component metallic bone fixation appliances and accessories

Common Name:
A) Suture Anchor
B) Suture Anchor | |
| Substantial
Equivalence | The GRYPHON X Anchors are substantially equivalent to the following predicate
and 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 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 | | |
| Technological
Characteristics | The anchor design, materials, principal of operation, and intended use of the
subject devices are identical to that of the predicate devices. The main differences
between the proposed devices and predicate devices are the additional suture
configurations and additional indications for use (GRYPHON X only). | |
| Indications for
Use | 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 | |
| | 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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-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 | |
| Non-clinical
Testing | Verification activities were assessed for the proposed devices. Verification
included an assessment of fixation strength for proposed indications at T=0 and
over the healing period (absorbable configuration), insertion force, fatigue strength,
as well as an assessment of needle attachment strength for the pre-loaded sutures in
scope of the submission. | |
| Safety and
Performance | Results of the analyses demonstrated that the devices continue to meet established
design inputs and corresponding criteria, and that there were no new issues of
safety or effectiveness related to device performance. | |
| | Based on similarities in the intended use, technological characteristics, and
performance in comparison to the predicate devices, the proposed GRYPHON X
Anchors and HEALIX TRANSTEND Anchors have shown to be substantially
equivalent to the predicate devices under the Federal Food, Drug and Cosmetic
Act. | |

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