FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire

K190125 · T.A.G. Medical Products Corporation, Ltd. · MBI · May 19, 2019 · Orthopedic

Device Facts

• Record ID: K190125
• Device Name: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
• Applicant: T.A.G. Medical Products Corporation, Ltd.
• Product Code: MBI · Orthopedic
• Decision Date: May 19, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures. The FiberStitch™ Meniscal Repair Device is indicated for use in meniscal repair procedures.

Device Story

FiberStitch™ is an all-inside meniscal repair device; consists of two non-absorbable polyester implants pre-tied with #2-0 non-absorbable sutures; preloaded into a needle delivery system. Features adjustable depth penetration limiter (10mm to 18mm range). Used in endoscopic soft tissue procedures; operated by surgeons. Deployment of sutures achieved via wheel rotation mechanism. Device facilitates suture retention in meniscal tissue; provides mechanical fixation for repair. Benefits include minimally invasive endoscopic access and secure tissue approximation.

Clinical Evidence

No clinical data. Bench testing only. Included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, package qualification, and device-specific surface, visual, dimensional, mechanical, and functional testing.

Technological Characteristics

All-inside meniscal repair device; non-absorbable polyester implants; #2-0 non-absorbable sutures; needle delivery system with adjustable depth penetration limiter (10-18mm). Mechanical deployment via wheel rotation. Sterilization: Ethylene oxide.

Indications for Use

Indicated for patients undergoing meniscal repair procedures requiring endoscopic soft tissue fixation.

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

• ULTRA FAST-FIX Meniscal Repair System (K121861)
• Maxfire Marxmen Meniscal Repair Device (K111564)
• Arthrex SpeedCinch (K132043)
• LOOK – Polyviolene Surgical Suture (K943949)

Submission Summary (Full Text)

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T.A.G. Medical Products Corporation, Ltd. Anat Rozen RA Manager Gaaton 2513000, Israel

## Re: K190125

Trade/Device Name: FiberStich™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 3, 2019 Received: April 8, 2019

### Dear Anat Rozen:

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

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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, fi 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, Ph.D. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative 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) K190125

#### Device Name

FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire®

#### Indications for Use (Describe)

The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures.

The FiberStitch™M Meniscal Repair Device is indicated for use in meniscal repair procedures.

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

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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K190125 Page 1 of 2

# 510(k) Summary

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1. | Submitter Address: | Shlomi Dines<br>T.A.G. Medical Products Corporation, Ltd.<br>Gaaton 2513000, ISRAEL<br>www.tag-med.com |
|----|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mfg. Phone: | Tel.: [phone] |
| | Contact Person: | Anat Rozen |
| | Date: | April 03, 2019 |
| 2. | Device & Classification<br>Name: | Suture Anchor, class II, 21 CFR 888.3040 Fastener, Fixation, Nondegradable, Soft<br>Tissue, product code MBI<br>FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire®<br>FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® |
| 3. | Predicate Devices: | K121861- Smith & Nephew - ULTRA FAST-FIX Meniscal Repair System<br>K111564- Biomet Sports Medicine - Maxfire Marxmen Meniscal Repair Device<br>K132043- Arthrex Inc. - Arthrex SpeedCinch<br>K943949- LOOK – Polyviolene Surgical Suture |
| 4. | Description: | The FiberStitch™ devices are an all-inside meniscal repair device. The devices<br>include two non-absorbable polyester implants, pre-tied with #2-0<br>non-absorbable sutures and preloaded into a needle delivery system. The<br>adjustable depth penetration limiter is preset to approximately 18mm from the<br>tip of the needle. It can be adjusted down in 2 (mm) increments to<br>approximately 10mm. |
| 5. | Intended Use: | The FiberStitch™ Meniscal Repair Device is intended for use as a suture<br>retention device to facilitate endoscopic soft tissue procedures.<br>The FiberStitch™ Meniscal Repair Device is indicated for use in meniscal<br>repair procedures. |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to its indication for use, the FiberStitch™ Implant, Curved<br>with two Polyester Implants and 2-0 FiberWire® and FiberStitch™<br>Implant, Straight with two Polyester Implants and 2-0 FiberWire® are<br>substantially equivalent to its predicate devices in their design which allows for the<br>devices to be endoscopically delivered from a single access point as the proposed<br>FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and<br>the FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire®<br>devices. Sutures material is similar to Maxfire Marxmen Meniscal Repair Device.<br>The clinical use is similar; devices are considered all-inside meniscal repair devices.<br>Conversely, FiberStitch™ Implant, Curved with two Polyester Implants and 2-0<br>FiberWire® and the FiberStitch™ Implant, Straight with two Polyester Implants and<br>2-0 FiberWire® are different than their predicate devices in geometry and details of<br>the operating mechanism while general dimensions are same. The deployment of<br>the sutures in FiberStitch™ Implant, Curved with two Polyester Implants and 2-0<br>FiberWire® and the FiberStitch™ Implant, Straight with two Polyester Implants and<br>2-0 FiberWire® is accomplished by rotating the wheel while for the predicate |

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MEDICAL PRODUCTS

devices deployment of sutures is accomplished by pushing the dedicated trigger. Suture materials are different albeit they are biocompatible. Nonclinical test discussion:

Nonclinical testing was completed to demonstrate that the FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® meets the established performance characteristics, and to verify that design requirements are satisfied. Testing included biocompatibility evaluation per ISO 10993-1, ethylene oxide sterilization validation, and package qualification. Device testing included surface/visual, dimensional, mechanical and functional testing. It was concluded that the FiberStitch™ Implant, Curved with two Polyester Implants and 2-0 FiberWire® and the FiberStitch™ Implant, Straight with two Polyester Implants and 2-0 FiberWire® are as safe and effective as the predicate devices.