OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM

K051656 · Osteobiologics, Inc. · HRX · Oct 25, 2005 · Orthopedic

Device Facts

• Record ID: K051656
• Device Name: OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
• Applicant: Osteobiologics, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OCT (Osteochondral Transplant) Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.

Device Story

OCT Comprehensive System is a kit of manual orthopedic surgical instruments; includes drill sleeve caps, drills, toothed core sleeves, plungers, obturators, sizers, drill handles, rulers, and sterilization trays. Instruments range from 3 to 11 mm. Used by surgeons in OR settings for osteochondral grafting procedures. Instruments facilitate the preparation of graft sites and delivery of osteochondral grafts to treat cartilage defects. System provides mechanical tools for site measurement, drilling, and graft placement. No electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual orthopedic surgical instruments. Materials: stainless steel and injection molded plastic. Dimensions: 3 to 11 mm. Sterilization: provided via sterilization tray. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring arthroscopic or open osteochondral grafting for the treatment of osteochondral (cartilage) defects in the knee or ankle.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Acufex MosaicPlasty Comprehensive System (K964215)

Submission Summary (Full Text)

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K05/656

# OCT 2 5 2005

## 510 (k) SUMMARY

| Submitter | Contact |
|-------------------------------|--------------------------------------|
| Image: OBI Logo | Gabriele G. Niederauer, Ph.D. |
| OsteoBiologics, Inc. | Director of Research and Development |
| 12500 Network, Suite 112 | Phone: [phone] (ext. 228) |
| San Antonio, Texas 78249, USA | Fax: [phone] |
| | E-mail: [e-mail] |

| Date of Summary: | June 16, 2005 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Drill Sleeve Caps, Drills, Obturators, Sizers, Handle, Ruler,<br>Drill Sleeves, Sterilization Tray, Delivery Device with<br>Measuring Tamp |
| Proprietary Name: | OCT (Osteochondral Transplant) Comprehensive System |
| Device Classification: | Orthopedic Manual Surgical Instruments, Template Surgical<br>Instruments Motors Accessories |
| 510(k) Number: | |
| Description of Device: | The OCT (Osteochondral Transplant) Comprehensive<br>System is a kit composed of several orthopedic surgical<br>instruments. These instruments include Drill Sleeve Cap,<br>Drills, Toothed Core Sleeve and Plunger, Obturators, Sizers,<br>Drill Handle, Ruler and Drill Sleeves and Sterilization Tray.<br>All instruments are composed of stainless steel and/or<br>injection molded plastic. The instruments range in size<br>from 3 to 11 mm. |
| Intended Use: | The OCT (Osteochondral Transplant) Comprehensive<br>System is indicated for arthroscopic (knee and ankle) and<br>open osteochondral grafting for the treatment of<br>osteochondral (cartilage) defects. |
| Substantial Equivalence: | The OCT (Osteochondral Transplant) Comprehensive<br>System is substantially equivalent in design, function and<br>performance to the Acufex " MosaicPlasty" Comprehensive<br>System cleared as K964215 on December 20, 1996. |

510(k) Premarket Notification: OCT (Osteochondral Transplant) Comprehensive System Confidential

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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, USA. The seal features a circular design with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of three abstract shapes, possibly representing human figures or birds in flight.

OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gabriele G. Niederauer, Ph.D. Director of Research and Development OsteoBiologics, Inc. 12500 Network, Suite 112 San Antonio, Texas 78249-3300

Re: K051656

K031030
Trade/Device Name: OCT (Osteochondral Transplant) Comprehensive System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: October 14, 2005 Received: October 17, 2005

Dear Dr. Niederauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 5 ro(x) proxice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manated posice Amendments, or to commerce provide to May 20, 1778, the enaochines with the provisions of the Federal Food. Drug. devices that have been reclassined in abost approval of a premarket approval application (PMA). and Cosmelle Act (Act) mat do not require approval controls provisions of the Act. The You may, ulcretore, market the det res, ocurements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of th thay be subject to such additional commons, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of I casral negerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not nean Please oc advised that I Dri 3 issuation of a device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I caeral statutes and regulations and using, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 607), and img (21 (OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2-Gabriele G. Niederauer, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow your o ocg... maing of substantial equivalence of your device to a legally prematics notification. The starsification for your device and thus, 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 If you desire specific at notier J - 4 [phone]. Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buend

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

Enclosure

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#### Indications for Use (Form) 2.4

#### INDICATIONS FOR USE

05 1656 510(k) Number (if known):

OCT (Osteochondral Transplant) Comprehensive System Device Name:

Indications For Use:

The OCT (Osteochondral Transplant) Comprehensive System is indicated for arthroscopic (Knee and The OCT (Osteochondral Transpian) Octopher Controllation of osteochondral (cartilage) defects.

Preseription 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harbare Bneem
Division Sign Off

. Restorative. Division of Ger and Neurological Devices

**510(k) Number** 2051654

540(k) Premarket Notification: (XT (Osteochondral Transplant) Comprehensive System Confidential