PLEXUR M

K081227 · Osteotech, Inc. · MQV · Jul 22, 2008 · Orthopedic

Device Facts

• Record ID: K081227
• Device Name: PLEXUR M
• Applicant: Osteotech, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Jul 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.

Device Story

PLEXUR M is a bone void filler composed of processed human bone particles and resorbable/biodegradable non-tissue components. Provided sterile for single use; requires heating via a compact single-use heater or water bath to achieve a moldable state. Surgeon packs or shapes material into osseous defects; material hardens upon cooling to body temperature. Can be further shaped, cut, or ground using conventional surgical instruments in its hardened state. Device is resorbed and replaced by host bone during healing. Used by surgeons in clinical settings to fill skeletal voids; supports bone in-growth and new bone formation.

Clinical Evidence

No human clinical data provided. Evidence consists of animal studies demonstrating that PLEXUR M supports bone in-growth and new bone formation at a rate at least comparable to predicate devices.

Technological Characteristics

Bone void filler containing processed human allograft bone and resorbable/biodegradable polymers. Provided sterile. Thermally activated (heated to become moldable, hardens at body temperature).

Indications for Use

Indicated for filling non-structural bony voids or gaps in the skeletal system (extremities and pelvis) resulting from surgery or traumatic injury. Also indicated for use as a bone void filler in the spine when used in conjunction with autograft.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Submission Summary (Full Text)

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K081227

7.0 510 (K) Summary of Safety and Effectiveness

July 14, 2008

- 1. Submission Applicant & Correspondent:
IJUL 2 2 2008

| Name: | Osteotech, Inc. |
|-----------------|---------------------|
| Address: | 51 James Way |
| | Eatontown, NJ 07724 |
| Phone No.: | [phone] |
| Contact Person: | Chris Talbot |

- 2. Name of Product:

| Trade/Proprietary/Model Name: | PLEXUR M ™ |
|-------------------------------|-----------------------------|
| Common or Usual Name: | Bone Void Filler |
| Classification Name: | Resorbable Bone Void Filler |

- 3. Devices to Which New Product is Substantially Equivalent:
PLEXUR M is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use.

- 4. Device Description:
PLEXUR M is a bone void filler product that contains, as a key constituent, processed human bone particles that are mixed with resorbable/biodegradeable non-tissue components. It is intended to be heated at the time of use, whereupon it becomes moldable, thus allowing the surgeon to pack it into the implant site or shape it to accommodate variations in the geometry and size of the particular implant site. As it cools down, the PLEXUR M returns to its normal hardened/rigid state and remains this way at body temperature. The surgeon may further shape, cut or grind PLEXUR M in the hardened state using conventional surgical instruments.

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PLEXUR M is packaged/provided for single use in a sterile form. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process. A compact, single use heater is available as a means to heat the PLEXUR M at the time of use to make it pliable. Alternatively, PLEXUR M may be heated in a water bath.

## 5. Intended Use/Indications

PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.

## 6. Technical Comparison

PLEXUR M is substantially equivalent to one or more of the predicate devices with respect to materials. PLEXUR M contains human allograft bone tissue, as does one or more of the predicate devices. PLEXUR M also contains resorbable polymer of the same type as those in one or more of the predicate devices. Also, like one or more of the predicate devices, PLEXUR M is provided sterile in various sizes that, upon heating (using a compact, single use sterile heater to be marketed by Osteotech), it is made moldable and can be cut or shaped by the user into various shapes or sizes. It may be further shaped by the surgeon in its hardened state using conventional surgical instruments.

## 7. Performance Data

The results of studies in animal showed that PLEXUR M supports bone in-growth and new bone formation to an extent at a rate at least comparable to predicate devices.

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K081227 (pg. 3 of 3)

- 8. Viral Inactivation
In the production of PLEXUR M, the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis B and C and CMV.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osteotech, Inc. % Mr. Chris Talbot 51 James Way Eatontown, NJ 07724

JUL 2 2 2008

Re: K081227 Trade/Device Name: PLEXUR MTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 29, 2008 Received: April 30, 2008

Dear Mr. Talbot:

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. Iisting 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. Chris Talbot

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 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. Millen

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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## 5.0 Indications for Use Statement

K081227 510(k) Number: Device Name; PLEXUR M

Indications for Use: PLEXUR M is intended for use in filling bony voids or gaps of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. In addition, Plexur M may be used in conjunction with autograft as a bone void filler in the spine. PLEXUR M is resorbed/remodeled and is replaced by host bone during the healing process.

| 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)

Saubare buentp

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Division of General. Restorative. and Neurological Devices

**510(k) Number** K081227