OSTEOBOOST-BMA

K062260 · Orthos Limited · FMF · Oct 26, 2006 · General Hospital

Device Facts

• Record ID: K062260
• Device Name: OSTEOBOOST-BMA
• Applicant: Orthos Limited
• Product Code: FMF · General Hospital
• Decision Date: Oct 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only. The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects, which can occur as a result of trauma, or in skeletal defects created surgically.

Device Story

The Orthos-BMA Kit is a sterile, single-use apparatus designed for minimally invasive bone marrow aspiration. Operated by trained surgical personnel in a clinical or surgical setting, the device facilitates the collection of autologous bone marrow. The harvested marrow is subsequently combined with an osteoconductive material, such as autogenous bone or synthetic bone void fillers (e.g., ßGran), to create a graft mixture. This mixture is applied by the surgeon to treat osseous defects caused by trauma or surgical intervention. The device provides a convenient, integrated method for graft preparation, potentially improving surgical efficiency and patient outcomes in bone repair procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Piston syringe-based apparatus for bone marrow aspiration. Supplied sterile for single-patient use. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by trained surgical personnel to harvest bone marrow and combine it with osteoconductive material (e.g., bone void filler) for treating osseous defects resulting from trauma or surgical skeletal defects.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "Orthos" in a bold, sans-serif font, with a stylized graphic to the left of the word. Below "Orthos" is the word "ORTHOBIOLOGICS" in a smaller, sans-serif font. The image is in black and white.

OCT 2 6 2006

# KOE2260 510(k) Summary of Safety and Effectiveness

In accordance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the subject device.

| Submitted By: | Orthos Limited |
|------------------------------------|----------------------------------|
| Date: | July 2006 |
| Contact Person: | Alan Rorke<br>Managing Director |
| Proprietary Name: | Orthos-BMA Kit |
| Common Name: | Piston Syringe |
| Classification Name and Reference: | Piston Syringe - 21 CFR 880.5860 |
| Device Product Code: | FMF |

Orthos Limited The Stables, Leigh Court, Abbots Leigh, Bristol, BS8 3RA, UK.

T: [phone] F: [phone]

> E: [e-mail] www.orthos.com

## DEVICE INFORMATION

#### A. Device Description

The Orthos-BMA™ kit contains the apparatus required for the collection of bone marrow using a minimally invasive aspiration technique.

The Orthos-BMA™ kit provides the surgeon with a convenient method of harvesting autologus bone marrow and combining it with their choice of osteoconductive material such as autogenous bone or a bone void filler such as ßGran synthetic osteoconductive scaffold.

The Orthos-BMA kit is supplied sterile for single patient use.

### B. Intended Use and indications

The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only.

The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects, which can occur as a result of trauma, or in skeletal defects created surgically.

## C. Substantial Equivalence Rationale

The intended use, the materials and design features employed in the Orthos-BMA™ kit are equivalent to those found in the predicate devices previously cleared for market as described in the pre-market notification. The safety and effectiveness of the Orthos-BMA kit are adequately supported by the data provided within the Pre-market Notification.

Image /page/0/Picture/18 description: The image shows two logos of Lloyd's Register Quality Assurance. The top logo includes the text "ISO9001" at the bottom, while the bottom logo includes the text "ISO13485". Both logos feature a large letter "R" inside a circle, surrounded by the text "LLOYD'S REGISTER QUALITY ASSURANCE".

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2006

Orthos Limited % Mr. Alan Rorke Managing Director The Sables, Leigh Court Abbots Leights, Bristol BS8 3RA, UK

Re: K062260

Trade/Device Name: The Orthos-BMA™ kit Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: October 10, 2006 Received: October 13, 2006

Dear Mr. Rorke:

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 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.

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Page 2 - Mr. Alan Rorke

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 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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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510(k) Number (if known): K062260 Device Name: Orthos-BMA™ Kit

Indications for Use:

The Orthos-BMA™ kit is intended for use by suitable trained surgical personnel only.

The Orthos-BMA™ kit contains the apparatus required to harvest bone marrow and to combine the harvested marrow cells with an osteoconductive material such as a bone void filler for use in the treatment of osseous defects which can occur as a result of trauma or in skeletal defects created surgically.

× Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General. Rostorative, and Neurological De ces

510(a) Number / 60726