Q-FIX ULTRA All-Suture Anchor

K232457 · Smith & Nephew · MBI · Sep 8, 2023 · Orthopedic

Device Facts

• Record ID: K232457
• Device Name: Q-FIX ULTRA All-Suture Anchor
• Applicant: Smith & Nephew
• Product Code: MBI · Orthopedic
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Q-FIX® ULTRA All-Suture Anchor is intended for use for the reattachment of soft tissue to bone.

Device Story

Q-FIX ULTRA All-Suture Anchor is a soft tissue fixation device; consists of all-suture anchor preloaded with ULTRATAPE suture; assembled inside an insertion device. Used by surgeons in orthopedic procedures to reattach soft tissue to bone. Device functions by inserting anchor into bone; provides mechanical fixation for tendon/ligament repairs. Benefits include secure soft tissue-to-bone attachment during healing. Operates via manual insertion; no electronic or software components.

Clinical Evidence

Bench testing only. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. All tests met pre-defined acceptance criteria. Biocompatibility evaluated per ISO 10993-1 and deemed safe.

Technological Characteristics

All-suture anchor with preloaded ULTRATAPE suture; includes insertion device. Materials are equivalent to predicate/reference devices. Sterilization method and packaging configuration are consistent with predicate. Mechanical fixation principle.

Indications for Use

Indicated for reattachment of soft tissue to bone in foot and ankle procedures, specifically medial or lateral instability repairs/reconstructions and Achilles tendon repairs/reconstructions.

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

• Q-Fix® Suture Anchor (K172165)

Reference Devices

• ULTRATAPE® Suture (K132357)
• Q-FIX® with Needles (K231376)

Submission Summary (Full Text)

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September 8, 2023

Image /page/0/Picture/1 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. 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Smith & Nephew Catherine Phelan Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K232457

Trade/Device Name: Q-FIX ULTRA All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, GAT, HTW Dated: August 14, 2023 Received: August 14, 2023

Dear Catherine Phelan:

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

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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 devices or postmarketing safety reporting (21 CFR 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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-regulatoryassistance/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,

Jesse Muir-S

Jesse Muir, Ph.D. Assistant Director 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

510(k) Number (if known) K232457

Device Name Q-FIX◊ ULTRA All-Suture Anchor

Indications for Use (Describe)

The Q-FIX? ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:

Foot and Ankle:

· Medial or lateral instability repairs/reconstructions

· Achilles tendon repairs/reconstructions

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

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|

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Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 Massachusetts, USA

T:+ 1 978 749 1000 T:+ 1 800 343 8386 (USA toll free) www.smith-nephew.com

# Smith Nephew

## 510(k) Summary

#### Prepared: 06 September 2023

| Submitter Information | Contact Information |
|-----------------------|--------------------------------------|
| Smith & Nephew, Inc. | Ms. Catherine Phelan |
| Endoscopy Division | Senior Regulatory Affairs Specialist |
| 150 Minuteman Road | [e-mail] |
| Andover, MA 01810. | |

| Device Name & Classification | |
|------------------------------|---------------------------------------------------------------------------------------------------|
| Proprietary Name | Q-FIX ® ULTRA All-Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, biodegradable, soft tissue;<br>fastener, fixation, nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MBI |
| Panel | Orthopedic |

#### Legally Marketed Predicate Devices

The Smith & Nephew O-FIX® ULTRA All-Suture Anchor is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:

| Description | Submission Number |
|----------------------|-------------------|
| Q-Fix® Suture Anchor | K172165 |

#### Legally Marketed Reference Device

| Description | Submission Number |
|---------------------|-------------------|
| ULTRATAPE® Suture | K132357 |
| Q-FIX® with Needles | K231376 |

#### Device Description

The Smith & Nephew Q-FIX® ULTRA All-Suture Anchor is a fixation device intended to provide reattachment of soft tissue to bone. The device consists of an all-suture anchor with a preloaded ULTRATAPE® suture assembled inside an insertion device.

#### Intended Use

The Q-FIX® ULTRA All-Suture Anchor is intended for use for the reattachment of soft tissue to bone.

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#### Indications for Use

The O-FIX® ULTRA All-Suture Anchor is only intended for the reattachment of soft tissue to bone for the following indications:

Foot & Ankle

- . Medial or lateral instability repairs/reconstructions
- . Achilles tendon repairs/reconstructions

#### Technological Characteristics

The changes to the legally marketed predicate device (Q-Fix^ Suture Anchor) include a modified inserter and the addition of preloaded ULTRATAPE^ Suture.

Q-FIX® ULTRA All-Suture Anchor is equivalent in its intended use, indications for use, manufacturing process, sterilization method, materials, packaging configuration, and design. The implantable materials in the subject device are equivalent to the materials of the predicate/reference devices. Additionally, many of the subject device components are identical compared to the predicate/reference devices. The differences between the subject device and predicate device are minor and raise no new questions of safety of effectiveness.

#### Performance Data

Non-clinical bench testing was completed on the subject device, and the device met all required specifications for each test. Testing included insertion testing, static fixation testing, cyclic loading testing, and knot tensile strength testing. A summary of test acceptance criteria and results have been provided. Results for all tests passed.

The biocompatibility of Q-FIX® ULTRA All-Suture Anchor was evaluated against the requirements per ISO 10993-1 and was deemed biologically safe.

#### Conclusion

The substantial equivalence of the Q-FIX® ULTRA All-Suture Anchor is based on similarities in indications for use, design features, operational principles, material biocompatibility and composition, and performance to the predicate/reference devices listed above. Based on the similarities, Q-FIX® ULTRA All-Suture Anchor is substantially equivalent to its predicate.