ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART

K082999 · Arthrex, Inc. · MAI · Dec 30, 2008 · Orthopedic

Device Facts

• Record ID: K082999
• Device Name: ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Dec 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex Meniscal Dart and Arthrex Meniscal Dartstick are intended to be use for the repair of meniscal tears. The Arthrex Chondral Dart is intended to be used for the fixation of small bone fragments. The Arthrex Meniscal Dart System is intended for the repair of Meniscal tears that would otherwise be considered for standard repair using suture. The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).

Device Story

Arthrex Meniscal Dart, Meniscal Dartstick, and Chondral Dart are biodegradable fixation devices; used for orthopedic repair of meniscal tears or small bone fragments. Devices function as mechanical fasteners; intended to replace or supplement traditional suture repair. Used by surgeons in clinical/OR settings. Output is physical fixation of tissue or bone fragments; aids in stabilization during healing process. This submission specifically addresses extended shelf life for these devices.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Biodegradable fixation pins/darts. Dimensions and materials are identical to previously cleared predicate devices. No software or electronic components.

Indications for Use

Indicated for patients requiring repair of meniscal tears (Meniscal Dart/Dartstick) or fixation of small bone fragments including apical, osteochondral, and cancellous fragments (Chondral Dart).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Arthrex Meniscal Dart System (K983577)
• Arthrex Chrondral Dart (K991971)

Submission Summary (Full Text)

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### DEC 3 0 2008

Arthrex SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral Dats

## 4 510(k) Summary of Safety and Effectiveness

| Manufacturer/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Nancy Hoft<br>Regulatory Affairs Associate<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1113<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral<br>Dart |
| Common Name | Pin, Dart |
| Product Code -<br>Classification Name | HTY-Pin, fixation, smooth MAI-Fastener, Fixation, Biodegradable, Soft Tissue |
| Predicate Devices | K983577, Arthrex Meniscal Dart System<br>K991971, Arthrex Chrondral Dart |
| Device Description<br>and Intended Use | The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex<br>Chondral Dart are identical to the predicate devices. The Arthrex<br>Meniscal Dart and Arthrex Meniscal Dartstick are intended to be use<br>for the repair of meniscal tears. The Arthrex Chondral Dart is<br>intended to be used for the fixation of small bone fragments. See the<br>Indications for Use statements for specific indications. |
| Substantial<br>Equivalence<br>Summary | The Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex<br>Chondral Dart are identical to the predicates Arthrex Meniscal Dart<br>System and Arthrex Chondral Dart in which the basic features and<br>intended uses are the same. Any differences between the Arthrex<br>Meniscal Dart, Arthrex Meniscal Dartstick, and Arthrex Chondral Dart<br>in comparison to the cleared devices in K983577 and K991971 are<br>considered minor and do not raise questions concerning safety and<br>effectiveness. Based on the information submitted, Arthrex, Inc. has<br>determined that the Arthrex Meniscal Dart, Arthrex Meniscal<br>Dartstick, and Arthrex Chondral Dart are substantially equivalent to<br>the currently marketed predicate devices. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2008

Arthrex, Inc. % Ms. Nancy Hoft Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K082999 Trade/Device Names: Arthrex Menical Dart System Arthrex Chondral Dart Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, IITY Dated: October 6, 2008 Received: October 8, 2008

Dear Ms. Hoft:

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. Nancy Hoft

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 100-100.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and this, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH)'s) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millerson

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

Enclosure

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Arthrex

AND THE THE SECTION CONSULTER COLLECTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION C

Arthree SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral Darts

# Indications for Use Form

### Indications for Use

510(k) Number:

K082999

Device Name:

Arthrex Menical Dart System

The Arthrex Meniscal Dart System is intended for the repair of Meniscal tears that would otherwise be considered for standard repair using suture.

Prescription Use _ X _ AND/OR Over-The-Counter Use _ er 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

Page 7 of 133

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Arthrex SPECIAL 510(k): Extended Shelf Life for Meniscal and Chondral DartsIndications for Use

| 510(k) Number: | K082999 |
|----------------|-----------------------|
| Device Name: | Arthrex Chondral Dart |

The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).

Prescription Use __ X_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
| | PAGE 1 of 1 |

(Division Signature)

Division of General, Restorative

and Neurology Devices

| 510(k) Number | K062999 |
|---------------|---------------|
| | Page 8 of 133 |