TRUESPAN Meniscal Repair System

K153667 · Medos International SARL · MBI · Mar 24, 2016 · Orthopedic

Device Facts

• Record ID: K153667
• Device Name: TRUESPAN Meniscal Repair System
• Applicant: Medos International SARL
• Product Code: MBI · Orthopedic
• Decision Date: Mar 24, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRUESPAN Meniscal Repair System is intended for use in meniscal repairs and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

Device Story

All-inside meniscal repair system; consists of two rigid backstops (absorbable PLGA or non-absorbable PEEK) connected by #2-0 Orthocord suture and UHMWPE braid. Pre-assembled implant and applier provided sterile for single-patient use. Used by orthopedic surgeons in clinical settings. Surgeon deploys backstops; compression achieved by pulling suture post to create bridge between implants, securing tissue. Facilitates meniscal repair and allograft fixation; benefits patient by providing stable fixation during healing.

Clinical Evidence

Bench testing only. Implant system strength evaluated in vitro and via cyclic bench-top testing. Biocompatibility confirmed via data and justification.

Technological Characteristics

Materials: PLGA (poly(lactide-co-glycolide)) or PEEK (polyaryletherketone) backstops; #2-0 Orthocord suture and UHMWPE braid. Mechanical fixation system. Sterile, single-use, pre-assembled applier.

Indications for Use

Indicated for meniscal repair and meniscal allograft transplant procedures, specifically for anchoring allografts to the meniscal rim.

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

• Fast-Fix 360 Meniscal Repair System (K121861, K092508)

Reference Devices

• Ultra Fast-Fix Meniscal Repair System (K121861, K072322)
• Omnispan Meniscal Repair System (K092836)

Submission Summary (Full Text)

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

March 24, 2016

Medos International SARL % Yayoi Fujimaki Regulatory Affairs Senior Associate Depuy Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K153667

Trade/Device Name: TRUESPAN™ Meniscal Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 17, 2016 Received: February 18, 2016

Dear Yayoi Fujimaki:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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,

# Mark N. Melkerson -S

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)

K153667

Device Name

Truespan Meniscal Repair System

#### Indications for Use (Describe)

The TRUESPAN Meniscal Repair System is intended for use in meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for the meniscal rim during allograft transplant procedures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The logo features a geometric design to the left of the company name, "DePuy Synthes," which is in a bold, dark blue font. Below that, "MITEK SPORTS MEDICINE" is written in a smaller, lighter blue font. Underneath the company name is the text "COMPANIES OF" followed by the Johnson & Johnson logo in red.

## 510(k) SUMMARY TRUESPAN™ Meniscal Repair System

| Date Summary<br>Prepared | December 18, 2015 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | |
| Manufacturer | Medos International SARL<br>Chemin-Blanc 38, Le Locle Neuchatel<br>CH 2400, Switzerland | |
| Contact Person | Yayoi Fujimaki<br>Regulatory Affairs Senior Associate<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA | Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Trade Name: TRUESPANTM Meniscal Repair System<br>Common Name: Fastener, fixation, degradable, soft tissue | |
| Device<br>Classification | MBI - Smooth or threaded metallic bone fixation fastener, classified as Class II, regulated per 21 CFR 888.3040. Orthopedic panel | |
| Predicate<br>Device | Predicate: Fast-Fix 360 Meniscal Repair System (K121861, K092508; Smith & Nephew) Reference: Ultra Fast-Fix Meniscal Repair System (K121861, K072322; Smith & Nephew) Reference: Omnispan Meniscal Repair System (K092836, DePuy Mitek) | |
| Indications for<br>Use | The TRUESPAN Meniscal Repair System is intended for use in meniscal repairs<br>and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair<br>System is intended to be used for anchoring the allograft to the meniscal rim<br>during allograft transplant procedures. | |
| Device<br>Description | The proposed device is an all-inside meniscal repair system. The implant<br>consists of two rigid backstops (absorbable PLGA*1 or non-absorbable PEEK*2),<br>size #2-0 Orthocord suture and UHMWPE braid. The implant system and<br>applier are pre-assembled, and the whole device is sterile, for single patient use<br>only. Compression of the fixation point is accomplished by pulling on the suture<br>post to allow the two suture strands creating the bridge between the implants to | |
| | lay tight on the surface of the fixation point.<br>*1 PLGA: Poly(lactide-co-glycolide)<br>*2 PEEK: polyaryletherketone | |
| Safety and<br>Performance | Implant system strength was evaluated in vitro and after cyclic (bench top). The<br>testing demonstrated substantial equivalence of performance to the predicate<br>device. Biocompatibility is also confirmed based on biocompatibility data and<br>justification. The proposed device has raised no new issue of safety and efficacy. | |
| Substantial<br>Equivalence | The proposed device is an all-inside meniscal repair system. The proposed<br>device consists of two rigid backstops and sutures. The technological<br>characteristics are similar to the predicate device. Implant system strength<br>demonstrated substantial equivalency of performance. Differences found<br>between the proposed and the predicate device are considered minor and do not<br>raise questions concerning safety and efficacy. The proposed device is<br>determined substantially equivalent to the predicate device. | |

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Image /page/5/Picture/0 description: The image contains the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The logo features a geometric design to the left of the text "DePuy Synthes" in a dark blue sans-serif font. Below this, "MITEK SPORTS MEDICINE" is written in a smaller, similar font. Underneath a thin line, the text "COMPANIES OF" appears above the Johnson & Johnson logo.

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