Who is the manufacturer of GRYPHON® Anchors with DYNACORD Suture?

Medos International SARL filed the 510(k) submission for GRYPHON® Anchors with DYNACORD Suture (K181809).

What is the FDA product code for GRYPHON® Anchors with DYNACORD Suture?

MAI. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for GRYPHON® Anchors with DYNACORD Suture?

510(k) clearance (submission type: Special).

What are the predicate devices for GRYPHON® Anchors with DYNACORD Suture?

GRYPHON® Anchors with PERMACORD™ Suture (K141259).

Who can help prepare an FDA 510(k) submission like GRYPHON® Anchors with DYNACORD Suture?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GRYPHON® Anchors with DYNACORD Suture

K181809 · Medos International SARL · MAI · Aug 3, 2018 · Orthopedic

Device Facts

Record ID	K181809
Device Name	GRYPHON® Anchors with DYNACORD Suture
Applicant	Medos International SARL
Product Code	MAI · Orthopedic
Decision Date	Aug 3, 2018
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Push-in suture anchor system; preloaded on disposable inserter; used for soft tissue-to-bone fixation. Available in absorbable BR or non-absorbable PEEK materials. DYNACORD™ suture component designed to resist laxity and minimize gap formation by maintaining approximation force (compression). Used by surgeons in clinical settings for orthopedic repairs. Device provides mechanical fixation; surgeon manually operates inserter to place anchor; output is secure tissue-to-bone attachment. Benefits include improved tension maintenance at repair site.

Clinical Evidence

Bench testing only. Performance testing included anchor fixation testing and in-vitro testing. Safety evaluations addressed sterility, packaging, shelf-life, and bacterial endotoxin limits. No clinical data presented.

Technological Characteristics

Push-in suture anchor; materials: absorbable BR or non-absorbable PEEK. Suture: DYNACORD™ non-absorbable, conforms to USP (except diameter). Sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, elbow, and hip procedures, including repairs of rotator cuff, ligaments, tendons, and labrum in adult patients.

Regulatory Classification

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.

Predicate Devices

GRYPHON® Anchors with PERMACORD™ Suture (K141259)

Reference Devices

HEALIX ADVANCE™ Anchors with DYNACORD™ Suture (K173859)

Related Devices

K133794 — 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 · Depuy Mitek, A Johnson & Johnson Company · Feb 4, 2014
K183506 — HEALIX ADVANCE Anchor with DYNACORD Suture · Medos International SARL · Feb 14, 2019
K141259 — GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK · Depuy Mitek, A Johnson & Johnson Company · Jun 10, 2014
K170639 — HEALIX ADVANCE Anchor with PERMATAPE Suture · Medos International SARL · May 18, 2017
K120824 — 3.9MM REELX STT SUTURE ANCHOR SYSTEM · Stryker Corp. · Jul 18, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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-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 | 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) ### 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY # GRYPHON® Anchors with DYNACORD™ Suture # 510k Document Number: K181809 ## Date Prepared: July 30th, 2018 | Submitter's Name and Address | DePuy Mitek a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Tatyana Korsunsky Regulatory Affairs Technical Manager DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767, USA Telephone: 508-828-3122 e-mail: tkorsuns@its.jnj.com | | Name of Medical Device | Proprietary Name: GRYPHON® Anchor with DYNACORD™ Suture: a) GRYPHON® BR Anchor with DYNACORD™ Suture b) GRYPHON® PEEK Anchor with DYNACORD™ Suture Classification Name: a) Single/multiple component metallic bone fixation appliances and accessories b) Smooth or threaded metallic bone fixation fasteners Common Name: Suture Anchor | | Substantial Equivalence | The GRYPHON® Anchors with DYNACORD™ Suture are substantially equivalent to: K141259 GRYPHON® Anchors with PERMACORD™ Suture Reference devices: K173859 HEALIX ADVANCE™ Anchors with DYNACORD™ Suture | | Device Classification | > 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 | | 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. | | Technological Characteristics | The proposed GRYPHON® Anchors with DYNACORD™ Suture has the same anchor materials, design, principle of operation, as well as device assembly, sterilization method, and shelf life, as predicate GRYPHON® Anchors with PERMACORD™ Suture (K141259). The DYNACORD™ Suture component is a non-absorbable suture that conforms to USP, except for oversized diameter. The DYNACORD™ Suture is designed to resist laxity and minimize gap formation, by maintaining approximation force (compression). DYNACORD™ Suture on the GRYPHON® Anchors is the same as the DYNACORD™ Suture on reference predicate HEALIX ADVANCE™ Anchors with DYNACORD™ Suture (K173859). | | Indications for Use | GRYPHON® BR Anchors with DYNACORD™ Suture are indicated for: 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 GRYPHON® 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 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. | {4}------------------------------------------------ {5}------------------------------------------------ | Non clinical Testing | Non-clinical testing has been performed on the proposed device and / or its predicates. 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 results have demonstrated that the proposed devices meet the endotoxin limits. | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Safety and Performance | Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed GRYPHON® Anchors with DYNACORD™ Suture has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. |