KATOR Suture Anchor

K173269 · Kator, LLC · MBI · May 30, 2018 · Orthopedic

Device Facts

• Record ID: K173269
• Device Name: KATOR Suture Anchor
• Applicant: Kator, LLC
• Product Code: MBI · Orthopedic
• Decision Date: May 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Hip: Capsular Repair, Acetabular Labral Repair.

Device Story

KATOR Suture Anchor facilitates soft tissue-to-bone fixation; consists of anchor body for bone tunnel placement and suture locking pin to secure suture tape. Used by orthopedic surgeons in clinical/OR settings. Device provides mechanical attachment of soft tissue to bone; enables surgical repair of ligaments, tendons, and capsules. Benefits include stable fixation during healing process. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only: insertion, pullout strength, and cyclic displacement testing performed on representative units. Pyrogenicity testing (Limulus amebocyte lysate/BET test) confirmed compliance with pyrogen limit specifications.

Technological Characteristics

Materials: PEEK (anchor body) and UHMWPE (suture). Mechanical fixation principle via bone tunnel anchor and locking pin. Non-electronic, non-software, mechanical device.

Indications for Use

Indicated for fixation of soft tissue to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic procedures. Applicable to adult patients requiring ligament, tendon, or capsular repair/reconstruction.

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

• Arthrex SwiveLock Anchors (K101823)
• Smith & Nephew Footprint PK Suture Anchor (K093897, K113274, K123579)
• KATOR LLC KATOR Suture Anchor (K162386)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo, which features a stylized human figure. 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 ADMINISTRATION" in blue text.

KATOR LLC Robert Hoy Director of Research 124 South 600 West. Suite 100 Logan, Utah 84321

Re: K173269

Trade/Device Name: KATOR 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: May 9, 2018 Received: May 9, 2018

Dear Mr. Hoy:

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);

May 30, 2018

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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,

# Katherine D. Kavlock -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

510(k) Number (if known)

K173269

Device Name KATOR Suture Anchor

#### Indications for Use (Describe)

The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 510(k) Summary

| Device Trade Name: | KATOR Suture Anchor |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | KATOR LLC<br>124 South 600 West, Suite 100<br>Logan, UT 84321 |
| Contact: | Mr. Robert Hoy<br>Director of Research<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | May 9, 2018 |
| Common Name: | Suture anchor |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | MBI |

#### Indications for Use:

The KATOR Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repairs, 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair.

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#### Device Description:

The KATOR Suture Anchor is designed to attach soft tissues to bone. It consists of an anchor body that is placed within a bone tunnel and a suture locking pin that secures soft tissue repair suture tape within the implant.

#### Predicate Devices:

The Arthrex, Inc., Arthrex SwiveLock Anchors (K101823), Smith & Nephew, Inc., Footprint PK Suture Anchor (K093897, K113274, K123579) and the KATOR LLC, KATOR Suture Anchor (K162386) serve as predicate devices.

#### Technological Characteristics Comparison:

The KATOR Suture Anchor subject device and the predicates are identical or similar in design, function, material, size and performance. The subject and predicate devices are designed to repair soft tissue by anchoring suture within a bone tunnel. The KATOR Suture Anchor subject device and both predicate devices contain UHMWPE suture material and are manufactured from PEEK, materials with well-established biocompatibility and a long history of use in many previously cleared permanent implants.

Side-by-side mechanical performance testing demonstrates that the design differences between the KATOR Suture Anchor subject device and the Arthrex SwiveLock Anchor predicate device introduce no new issues of safety or effectiveness.

#### Nonclinical Testing:

All necessary testing has been performed for the worst-case KATOR Suture Anchor to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the KATOR Suture Anchor was characterized through Insertion, Pullout Strength, Cyclic Displacement Testing. In addition pyrogenicity testing using the Limulus amebocyte lysate (BET) test, Turbidimetric Technique demonstrated the subject device meets the pyrogen limit specifications.

Clinical data were not needed to support the safety and effectiveness of the subject device.

#### Substantial Equivalence:

The KATOR LLC KATOR Suture Anchor is substantially equivalent to the Arthrex, Inc.. Arthrex SwiveLock Anchors (K101823), Smith & Nephew, Inc., Footprint PK Suture Anchor (K093897, K113274, K123579) and the KATOR LLC, KATOR Suture Anchor (K162386) with respect to its indications for use, design, material, size, performance and function.