ICONN Revolution Knotless Suture Anchor

K182264 · Iconn Orthopedics, LLC · MBI · Oct 19, 2018 · Orthopedic

Device Facts

• Record ID: K182264
• Device Name: ICONN Revolution Knotless Suture Anchor
• Applicant: Iconn Orthopedics, LLC
• Product Code: MBI · Orthopedic
• Decision Date: Oct 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Device Story

Sterile, single-use knotless suture anchor system; used for reattaching soft tissue to bone in shoulder, foot, and ankle procedures. Device consists of PEEK anchor (5mm x 23mm) and disposable inserter; used with UHMWPE sutures/tape. Operated by orthopedic surgeons in clinical/OR settings. Surgeon inserts anchor into bone; knotless mechanism secures soft tissue without manual knot tying. Provides stable fixation to facilitate healing. Bench testing confirms pullout strength and torsional properties comparable to predicate.

Clinical Evidence

Bench testing only. Mechanical testing included cyclic loading and ultimate pull-out strength per FDA guidance. Torsional properties and driving torque analyzed per ASTM F543-2013. Biocompatibility testing (cytotoxicity, irritation, sensitization) performed per ISO 10993-1:2013. Pyrogenicity testing conducted per ANSI/AAMI ST72:2006; results <0.05 EU/device.

Technological Characteristics

Material: Solvay Zeniva ZA-500 PEEK. Inserter/Driver: 17-4 stainless steel. Sutures/Tape: UHMWPE. Dimensions: 5mm x 23mm. Sterilization: Gamma irradiation. Mechanical standards: ASTM F543-2013 (torsional properties/driving torque). Biocompatibility standards: ISO 10993-1:2013, ANSI/AAMI ST72:2006.

Indications for Use

Indicated for patients requiring soft tissue to bone reattachment in the shoulder (rotator cuff, Bankart, biceps tenodesis, AC separation, deltoid, capsular shift/reconstruction) and foot/ankle (lateral/medial stabilization, Achilles repair, hallux valgus, mid-foot reconstruction, metatarsal ligament repair).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897)

Submission Summary (Full Text)

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October 19, 2018

ICONN Orthopedics, LLC Whitt Israel Chief Executive Officer 400 Union Hill Drive, Suite 150 Birmingham, Alabama 35209

Re: K182264

Trade/Device Name: ICONN Revolution Knotless Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 20, 2018 Received: August 21, 2018

Dear Mr. Israel:

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/cdrl/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, 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laurence D. Coyne -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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K182264

Device Name

ICONN Revolution Knotless Suture Anchor

#### Indications for Use (Describe)

The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament 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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Image /page/3/Picture/0 description: The image shows the logo for "ICONN Orthopedics". The logo consists of the word "ICONN" in a gray sans-serif font, with a blue circle in the middle of the word. Below the word "ICONN" is the word "ORTHOPEDICS" in a smaller gray sans-serif font, with two gray lines on either side of the word.

400 Union Hill Drive, Suite 150 Birmingham, AL 35209

## 510(k) SUMMARY

| Submitter's Name: | ICONN Orthopedics, LLC |
|---------------------------------|-----------------------------------------------------------|
| Submitter's Address: | 400 Union Hill Drive<br>Suite 150<br>Birmingham, AL 35209 |
| Submitter Contact Person: | Whitt Israel<br>CEO<br>[phone] |
| Date Summary was Prepared: | August 20, 2018 |
| Trade Name or Proprietary Name: | ICONN Revolution Knotless Suture Anchor |
| Common or Usual Name: | Suture Anchor |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Panel: | Division of Orthopedic Devices |

Device Description: The ICONN Revolution Knotless Suture Anchor (P/N 350000) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in one size (Diameter x Length): 5mm x 23mm. The implants with attached disposable inserter are supplied sterile and the instrument is supplied Non-Sterile and is to be sterilized in the ICONN instrument tray prior to surgery. The disposable inserter is made out of 17-4 stainless steel and the reusable driver is made out of 17-4 stainless steel (shaft) and silicone (handle). All anchors are intended to be used with the supplied #2 sutures and/or 1.5mm ICONN TetherTape, both made from Ultra High Molecular Weight Polyethylene (UHMWPE). The sutures/tape are supplied sterile, are packaged individually, and are single strands measuring 36/38 inches in length. The ICONN Revolution Knotless Suture Anchor is intended for the Intended Use: reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

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Foot/Ankle: Lateral stabilization. Medial stabilization. Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair. Predicate Device: The predicate device was selected to help demonstrate substantial equivalence of several characteristics to include intended use, design, size, PEEK material, and supplying the device in the sterile state. The predicate device is listed below: . Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) Technological The ICONN Revolution Knotless Suture Anchor Characteristics: is of similar design to the predicate and is manufactured with the same basic material in similar size. Performance Data: Performance testing was conducted for both pullout characteristics and torsional properties. For pullout characteristics, the FDA's Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996) was used for quidance in side by side mechanical testing performed on the subject device and predicate for the following test modes: . Anchor displacement after cyclic loading . Ultimate anchor pull-out Pullout testing showed that the ICONN Revolution Knotless Suture Anchor performed similarly or better than the predicate or within acceptable ranges for the intended use. For insertion testing. ASTM F543-2013 was followed, specifically the sections on torsional properties (section A1 of the standard) and driving torque (section A2 of the standard) were analyzed and compared to demonstrate the device can be safely implanted. Cytotoxicity, irritation, and sensitization testing were carried out in accordance with ISO 10993/(R)2013 and all testing met acceptance criteria. In accordance with ANSI/AAMI ST72:2006 LAL testing conducted using the Kinetic-Chromogenic assay and the results demonstrated the test article were <0.05 EU/device. Materialmediated pyrogenicity testing was conducted and the device was determined to be non-pyrogenic. Conclusion: The Revolution Knotless Suture Anchor is substantially equivalent to the predicate and does not raise different questions of safety and effectiveness.