OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141

K092836 · Depuy Mitek, A Johnson & Johnson Company · MBI · Feb 4, 2010 · Orthopedic

Device Facts

• Record ID: K092836
• Device Name: OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL REPAIR SYSTEM/12 DEGREE, MODEL 228141
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MBI · Orthopedic
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.

Device Story

OMNISPAN Meniscal Repair System facilitates arthroscopic meniscal repair; consists of two PEEK implants connected by sliding loop and fixed leg of absorbable #2-0 Orthocord suture; includes sterile, disposable deployment gun with malleable graft retractor. Implants and suture provide compression across meniscal tear. Used by surgeons in arthroscopic procedures. Benefits include secure soft tissue fixation to promote healing.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: PEEK (polyetheretherketone) implants, absorbable #2-0 Orthocord suture. Components: Deployment gun, malleable graft retractor. Principle: Mechanical fixation via sliding loop and suture compression. Form factor: Sterile, disposable arthroscopic instrumentation.

Indications for Use

Indicated for arthroscopic soft tissue fixation, specifically meniscal 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

• Mitek Fapidloc Meniscal Repair Device (K002406)
• Mitek PDS Rapidloc Meniscal Repair Device (K023388)

Reference Devices

• Mini Quickanchor and Quickanchor Plus with Size #2-0 Orthocord (K071257)
• Double Armed Meniscal Needles with Size #2-0 Orthocord (K080918)
• Smith & Nephew Ultra Fast-Fix Device (K072322)
• Arthrex Meniscal Cinch (K073149)

Submission Summary (Full Text)

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K092836 p. 10f 2

## SECTION 2 – 510(%) SUMMARY

| | FEB - 4 2010<br>OMNISPAN Meniscal Repair System |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
| Contact Person | Ruth C. Forstadt, RAC<br>Manager, Regulatory Affairs<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6955<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name: Smooth or threaded metallic bone fixation<br>fastener |
| | Common/Usual Name: Bone Fixation Fastener |
| | Proprietary Name: OMNISPAN Meniscal Repair System |
| Device Classification | This device carries FDA product codes MBI, NEW and GAT, and is<br>classified as Smooth or threaded metallic bone fixation fastener under<br>21 CFR 888.3040. |
| Device Description | The proposed OMNISPAN Meniscal Repair System consists of two<br>sterile PEEK (polyetheretherketone) implants connected by a sliding<br>loop and fixed leg of absorbable size #2-0 Orthocord suture, a sterile,<br>disposable Deployment Gun with malleable Graft Retractor. The<br>implants together with the suture provide compression across the tear in<br>the meniscus. |
| Indications for Use | The proposed OMNISPAN Meniscal Repair System is intended for<br>use in the arthroscopic fixation of soft tissue procedures such as<br>meniscal repair. |

Premarket Notification: Traditional
Omnispan Meniscal Repair System

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Substantial Equivalence

The proposed OMNISPAN Meniscal Repair System is substantially equivalent to:

- K002406 Mitek Fapidloc Meniscal Repair Device 8 (February 15, 2001);
- K023388 Mitek PDS Rapidloc Meniscal Repair Device (December 27, 2002).

The size #2-0 Orthocord suture provided with the proposed OMNISPAN Meniscal Repair System is identical to the size #2-0 Orthocord in:

- K071257 Mini Quickanchor and Quickanchor Plus with Size #2-0 Orthocord (June 29, 2007);
- 트 K080918 Double Armed Meniscal Needles with Size #2-0 Orthocord (April 23, 2008).

The proposed OMNISPAN Meniscal Repair System is also similar to:

- 트 K072322 Smith &: Nephew Ultra Fast-Fix Device (September 18, 2007);
- K073149 Arthrex Meniscal Cinch (February 11, 2008).

## Safety and Performance

Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.

Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed OMNISPAN Meniscal Repair System has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Depuy Mitek c/o Ms. Ruth Forstadt Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

FEB - 4 2010

Re: K092836

Trade/Device Name: OMNISPAN Meniscal Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastner Regulatory Class: Class II Product Code: MBI, NEW, GAT . Dated: January 29, 2010 Received: February 1, 2010

Dear Ms. Forstadt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Ruth Forstadt

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 go to http://www.fdg.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Barbara Buell

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

Enclosure

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## Indications for Use

510(k) Number (if known): K.092834

Device Name: OMNISPAN Meniscal Repair System

Indications for Use:

The proposed OMNISPAN Meniscal Repair System is intended for use in the arthroscopic fixation of soft tissue procedures such as meniscal repair.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Barbara Buell Dorman

Division Sign-O Division Sign-Only
Division of Surgical, Orthopedic, Division of Storative Devices

510(k) Number K092836