HEALIX ADVANCE KNOTLESS BR Anchor

K180101 · Medos International SARL · MAI · May 10, 2018 · Orthopedic

Device Facts

• Record ID: K180101
• Device Name: HEALIX ADVANCE KNOTLESS BR Anchor
• Applicant: Medos International SARL
• Product Code: MAI · Orthopedic
• Decision Date: May 10, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis Foot/Ankle: Achilles Tendon Repair

Device Story

HEALIX ADVANCE KNOTLESS BR Anchor is a one-piece, implantable, cannulated, threaded anchor; designed to secure soft tissue to bone. Provided pre-loaded on a disposable inserter driver. Used by surgeons in orthopedic procedures (shoulder, knee, foot/ankle). Implanted into bone to provide fixation for soft tissue repairs. Benefits patient by facilitating secure reattachment of tendons/ligaments to bone during surgical repair.

Clinical Evidence

Bench testing only. Performance evaluation included fixation strength and insertion torque at time zero and in-vitro testing. Device confirmed non-pyrogenic per ANSI/AAMI ST-72:2011, USP, and EP standards using bacterial endotoxin testing.

Technological Characteristics

Cannulated, threaded anchor; 4.75mm, 5.5mm, and 6.5mm sizes. Material: Biocryl Rapide (BR). Provided sterile, single-use. Includes disposable inserter driver. Non-pyrogenic per ANSI/AAMI ST-72:2011.

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder (rotator cuff, biceps tenodesis, deltoid repair), knee (posterior oblique, MCL, LCL, IT band tenodesis), and foot/ankle (Achilles tendon repair) procedures.

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

• HEALIX ADVANCE KNOTLESS Anchor (K171114)
• HEALIX ADVANCE KNOTLESS Anchor (K130917)
• HEALIX ADVANCE KNOTLESS Anchor (K131974)
• HEALIX ADVANCE KNOTLESS Anchor (K130539)
• HEALIX ADVANCE KNOTLESS Anchor (K131683)
• HEALIX ADVANCE KNOTLESS Anchor (K101679)
• HEALIX ADVANCE KNOTLESS Anchor (K082810)
• HEALIX ADVANCE KNOTLESS Anchor (K071177)
• HEALIX ADVANCE KNOTLESS Anchor (K061863)
• HEALIX ADVANCE KNOTLESS Anchor (K051219)
• Arthrex PushLock Anchors

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

Medos International SARL % Ashley Goncalo Senior Regulatory Affairs Specialist DePuv Synthes Mitek Sports Medicine. a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

May 10, 2018

Re: K180101

Trade/Device Name: HEALIX ADVANCE™ KNOTLESS BR 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 Dated: April 9, 2018 Received: April 10, 2018

Dear Ms. Goncalo:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

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) K180101

Device Name HEALIX ADVANCE™ KNOTLESS BR Anchor

Indications for Use (Describe)

The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair

Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis

Foot/Ankle: Achilles Tendon 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 HEALIX ADVANCE™ KNOTLESS BR Anchor

Date Prepared: 1/12/2018

| Submitter's<br>Name and<br>Address | DePuy Synthes Mitek Sports Medicine<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br><br>On behalf of:<br>Medos International SARL<br>Chemin-Blanc 38, Le Locle Neuchatel<br>CH 2400, Switzerland | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Contact Person | Ashley Goncalo<br>Sr. Regulatory Affairs Specialist<br>DePuy Synthes Mitek Sports Medicine<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | Telephone: [phone]<br>Email: [e-mail] |
| Name of Medical<br>Device | Proprietary Name: HEALIX ADVANCE KNOTLESS BR Anchor<br>Classification Name: Single/multiple component metallic bone fixation<br>appliances and accessories<br>Common Name: Suture Anchor | |
| Substantial<br>Equivalence | The HEALIX ADVANCE KNOTLESS BR Anchor is substantially<br>equivalent to:<br>K171114, K130917, K131974, K130539, K131683 HEALIX<br>ADVANCE KNOTLESS Anchor K101679, K082810, K071177, K061863, K051219 Arthrex<br>PushLock Anchors | |
| Device<br>Classification | HEALIX ADVANCE KNOTLESS BR Anchor is classified as:<br><br>Single/multiple component metallic bone fixation appliances and<br>accessories, classified as Class II, product code MAI, regulated under<br>21 CFR 888.3030. | |
| Device<br>Description | The HEALIX ADVANCE KNOTLESS BR Anchor is a one piece<br>implantable cannulated, threaded anchor designed to secure soft tissue<br>to bone. The anchor is provided loaded on a disposable inserter driver<br>device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm<br>and 6.5mm. The HEALIX ADVANCE KNOTLESS BR Anchors are<br>molded from Biocryl Rapide® (BR) material. The HEALIX<br>ADVANCE KNOTLESS BR Anchor is provided sterile and is for<br>single use only. | |
| Technological<br>Characteristics | The suture anchor design, anchor and suture materials, and finished<br>good assembly design remain the same when compared to the predicate<br>HEALIX ADVANCE KNOTLESS Anchors (K171114, K130917,<br>K131974, K130539, K131683). | |
| Indications for<br>Use | The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for<br>use in the following procedures for reattachment of soft tissue to bone:<br><br>Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Deltoid Repair<br><br>Knee: Posterior Oblique, Medial Collateral Ligament (MCL),<br>Lateral Collateral Ligament (LCL), Iliotibial (IT) Band<br>Tenodesis<br><br>Foot/Ankle: Achilles Tendon Repair | |
| Non-clinical<br>Testing | Verification activities were performed on the proposed device and / or<br>its predicates. Performance testing included evaluation of fixation<br>strength and insertion torque at time zero as well as in-vitro testing.<br>The proposed device has been determined to be non-pyrogenic per the<br>requirements set forth in ANSI/AAMI ST-72:2011, United States<br>Pharmacopeia (USP), and European Pharmacopeia (EP) using the<br>bacterial endotoxin testing (BET) method. | |
| Safety and<br>Performance | Results of performance testing have demonstrated that the proposed<br>devices are suitable for their intended use.<br><br>Based on similarities in the indications for use, technological<br>characteristics, and performance in comparison to the predicate devices,<br>the proposed HEALIX ADVANCE KNOTLESS BR Anchor has shown | |

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to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act