A.I.M. KNOTLESS MENISCAL REPAIR DEVICE

K133770 · Anchor Innovation Medical (A.I.M.) · GAT · Jun 10, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133770
• Device Name: A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
• Applicant: Anchor Innovation Medical (A.I.M.)
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jun 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.

Device Story

Device consists of two implants pre-threaded with USP Size 0 Ultra High Molecular Weight Polyethylene (UHMWPE) suture, pre-loaded into a needle delivery device. Used by surgeons in clinical settings for percutaneous or endoscopic soft tissue repair, including meniscal tears. Needle tips available in straight, curved, or reverse-curved configurations. Device facilitates tissue approximation by deploying implants and tensioning/locking the suture without requiring manual knot tying. Output is a secured suture construct within the tissue. Clinical benefit includes simplified repair procedure and effective tissue fixation.

Clinical Evidence

Bench testing only. Performance testing confirmed pull-out strength and cyclic loading performance are equivalent or superior to the predicate device. Biocompatibility testing conducted per ISO 10993 standards.

Technological Characteristics

Implantable suture retention device. Materials: USP Size 0 Ultra High Molecular Weight Polyethylene (UHMWPE) suture. Delivery: Needle-based delivery system (straight, curved, reverse-curved). Biocompatibility: ISO 10993 compliant. Sterilization: Validated process.

Indications for Use

Indicated for patients requiring percutaneous or endoscopic soft tissue repair, specifically for the repair of meniscal tears.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Smith & Nephew, ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS (K072322)

Submission Summary (Full Text)

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## 510(K) SUMMARY: A.I.M. KNOTLESS MENISCAL REPAIR DEVICE

| Submission Date: | December 11, 2013 | JUN 10 2014 |
|------------------------|-------------------|-------------|
| Submitter Information: | | |

| Company: | Anchor Innovation Medical (A.I.M.) |
|----------|------------------------------------|
| | 5410 Edson Lane |
| | Suite 308 |
| | Rockville, MD 20852 |

| Contact Person: | Cary Stalnecker |
|-----------------|-------------------------|
| | Chief Executive Officer |

## Correspondent Information:

Karen M. Becker, Ph.D. 5410 Edson Lane, Suite 308 Rockville, MD 20852

Phone: [phone] Fax: [phone] Email: [e-mail]

## Device Information:

,

| Trade Name: | A.I.M. Knotless Meniscal Repair Device |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Name: | Suture, non-degradable |
| Classification: | 21 CFR 878.5000 |
| Product Codes: | GAT |
| Device Class: | Class II |
| Predicate Devices: | Smith & Nephew, ULTRA FAST-FIX AND ULTRA FAST-FIX<br>AB MENISCAL REPAIR SYSTEMS (K072322) |
| Intended Use: | The A.I.M. Knotless Meniscal Repair Device is an implantable<br>suture retention device which facilitates percutaneous or<br>endoscopic soft tissue repair, including the repair of meniscal tears. |

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| Device Description: | The A.I.M. Knotless Meniscal Repair Device is comprised of two implants pre-threaded with commercially available Ultra High Molecular Weight Polyethylene, USP Size 0 suture pre-loaded into a needle delivery device that will allow the surgeon to repair soft tissue, including a meniscal repair. The needle tip may be available straight, curved, and/or reverse-curved. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence Summary: | The A.I.M. Knotless Meniscal Repair Device is substantially equivalent to the cited predicate, Smith & Nephew's Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems (K072322), having the same, or similar, intended use, indications for use, and fundamental scientific technology. |
| | The A. I.M. Knotless Meniscal Repair Device employs a different method for deploying the implants, and for tensioning and locking the suture. These differences do not raise new questions of safety or effectiveness. |
| Performance Testing: | Bench testing was conducted to confirm that the A.I.M. Knotless Meniscal Repair Device performs as well or better than the predicate on pull-out performance and cyclic loading. |
| Safety Testing: | The A.I.M. Knotless Meniscal Repair Device was determined to be biocompatible based on the component materials, conformity with recognized standards, and testing consistent with the requirements of ISO 10993. Sterilization and packaging validation are consistent with product labeling. |
| Conclusion: | Based on the similarity in intended use, materials, and fundamental scientific technology, performance testing and safety testing, the A.I.M. Knotless Meniscal Repair Device is as safe and effective, and performs as well or better than, the predicate. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2014

Anchor Innovation Medical % Karen M. Becker, Ph.D. 5410 Edson Lane, Suite 308 Rockville, Maryland 20852

Re: K133770

Trade/Device Name: A.I.M. Knotless Meniscal Repair Device Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: May 20, 2014 Received: May 21, 2014

Dear Dr. Becker:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Karen M. Becker, Ph.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Lori A. Wiggins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K133770 Page 1 of 1

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known): K 133770

Device Name:

A.I.M. Knotless Meniscal Repair Device

Indications for Use:

The A.I.M. Knotless Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repair, including the repair of meniscal tears.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -A

(Division Sign-Off) Division of Orthopedie Devices 510(k) Number: K133770

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