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K Number
K080511
Device Name
PLEXUR-P
Manufacturer
OSTEOTECH, INC.
Date Cleared
2008-04-21

(56 days)

Product Code
MQV
Regulation Number
888.3045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.
Device Description
PLEXUR P is bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Plexur P mav also be used as a bone graft extender in the spine. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.
More Information

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No
The summary describes a bone void filler material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.

Yes
The device is used to fill bony voids or gaps and acts as a bone graft extender, which are therapeutic interventions aimed at promoting healing and restoring bone structure.

No

Explanation: The device, PLEXUR P, is described as a bone void filler and bone graft extender used in the skeletal system. Its intended use is to fill bony voids or gaps and support bone in-growth and new bone formation, which are therapeutic and reconstructive functions, not diagnostic ones. Diagnostic devices are used to identify or characterize medical conditions.

No

The device description clearly states that PLEXUR P is a bone void filler containing processed human allograft bone tissue and a resorbable polymer, indicating it is a physical material, not software.

Based on the provided information, PLEXUR P is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use of PLEXUR P is to fill bony voids or gaps in the skeletal system and act as a bone graft extender. This is a therapeutic and structural application within the body.
  • Device Description: The device is described as a bone void filler containing human allograft bone tissue and a resorbable polymer, intended for direct implantation into the body.
  • Lack of Diagnostic Function: There is no mention of PLEXUR P being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

IVD devices are specifically designed to perform tests on samples taken from the body (like blood, urine, tissue) to diagnose diseases, monitor conditions, or determine compatibility. PLEXUR P's function is to physically fill and support bone healing within the body.

N/A

Intended Use / Indications for Use

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

Product codes

MQV

Device Description

PLEXUR P is bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Plexur P mav also be used as a bone graft extender in the spine. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skeletal System (spine, pelvis, extremities)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
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.(b)
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.

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VII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Mar. 31. 2008

    1. Submission Applicant & Correspondent:
      APR 2 1 2008
Name:Osteotech, Inc.
Address:51 James Way
Eatontown, NJ 07724
Phone No .:(732) 542-2800
Contact Person:Chris Talbot
    1. Name of Product:
Trade/Proprietary/Model Name:PLEXUR P
Common or Usual Name:Bone Void Filler
Classification Name:Resorbable Bone Void Filler
    1. Devices to Which New Product is Substantially Equivalent:
      PLEXUR P is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use.
    1. Device Description:
      PLEXUR P is bone void filler that contains as its principal constituents processed human allograft bone tissue and a resorbable polymer. PLEXUR P is produced in various physical forms/shapes/geometries and may be further shaped or cut by the surgeon to meet the particular needs and preferences of the surgeon. PLEXUR P is intended for use as bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities) not intrinsic to the stability of the bony structure. Plexur P mav also be used as a bone graft extender in the spine. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use.
    1. Intended Use/Indications
      PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, 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 resulting from traumatic injury to the bone. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.

1

6. Technical Comparison

PLEXUR P is substantially equivalent to one or more of the predicate devices with respect to materials. PLEXUR P contains human allograft bone tissue and polymer that are resorbed and/or remodeled into new host bone. The predicate devices also contain materials that are resorbed and /or remodeled into new host bone. Moreover, like the predicate devices, PLEXUR P is provided ready-to-use in various forms that can be cut or shaped by the user into various shapes or sizes.

    1. Performance Data
      The results of studies in animal showed that PLEXUR P supports bone in-growth and new bone formation to an extent at a rate at least comparable to predicate devices.
    1. Viral Inactivation
      In the production of Plexur P, the allograft bone is subjected to processing steps that have been shown to inactivate viruses, including HIV, hepatitis B and C and CMV.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 2 1 2008

Re: K080511

Trade/Device Name: PLEXUR P Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 22, 2008 Received: February 25, 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). and coosine . For ( roy ) rest the device, subject to the general controls provisions of the Act. The r ou may, attrefere, missions 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has Intact a and regulations administered by other Federal agencies. You must or any I oderal states and see and see and the best he 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.

3

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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millican

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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Indications for Use - Statement V.

K080511 510(k) Number (if known):_

Device Name: PLEXUR P

Indications for Use:

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

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden facnxm

Division of General, Restorative, and Neurological Devices

510(k) Number K080511