← Product Code [MBP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBP) · K061982 # PLEXUR P (K061982) _Osteotech, Inc. · MBP · Feb 7, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBP/K061982 ## Device Facts - **Applicant:** Osteotech, Inc. - **Product Code:** [MBP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBP.md) - **Decision Date:** Feb 7, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3045 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, 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 is resorbed/remodeled and is replaced by host bone during the healing process. ## Device Story PLEXUR P is a bone void filler composed of processed human allograft bone tissue and a resorbable polymer. Provided in various ready-to-use physical forms/geometries; surgeon may cut or shape device to fit specific defect. Intended for single patient use in filling non-structural bony voids or gaps (extremities, pelvis) caused by surgery or trauma. Device acts as a scaffold; resorbed and remodeled by host bone during healing. Processing includes viral inactivation steps for HIV, hepatitis B/C, and CMV. ## Clinical Evidence Animal studies demonstrated that PLEXUR P supports bone ingrowth and new bone formation. No human clinical data provided. ## Technological Characteristics Composition: processed human allograft bone tissue and resorbable polymer. Form: various ready-to-use geometries, shapeable/cuttable by user. Single patient use. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K061982 # VI. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS Jan. 31. 2007 7 2007 FEB 1. Submission Applicant & Correspondent: | Name: | Osteotech, Inc. | |-----------------|-------------------------------------| | Address: | 51 James Way
Eatontown, NJ 07724 | | Phone No .: | (732) 542-2800 | | Contact Person: | Chris Talbot | - 2. Name of Product: | Trade/Proprietary/Model Name: | PLEXUR P | |-------------------------------|-----------------------------| | Common or Usual Name: | Bone Void Filler | | Classification Name: | Resorbable Bone Void Filler | - 3. 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. - 4. Device Description: PLEXUR P is a 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 a bone void filler in bony voids or gaps of the skeletal system (i.e., extremities, pelvis) not intrinsic to the stability of the bony structure. PLEXUR P is provided in ready-to-use form in various package sizes by volume or dimension and is intended for single patient use. - 5. Intended Use/Indications PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, 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 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, as does one or more of the predicate devices. PLEXUR P 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 P is provided ready-touse in various forms that can be cut or shaped by the user into various shapes or sizes. ## 7. Performance Data The results of studies in animals showed that PLEXUR P supports bone ingrowth and new bone formation. ## 8. 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 symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle symbol is composed of three curved lines that form the shape of an eagle's head and wing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Osteotech, Incorporated c/o Mr. Christopher W. Talbot Director of Regulatory Affairs 51 James Way Eatontown, New Jersey 07724 7 2007 FEB Re: K061982 Trade Name: Plexur P Regulation Number: 21 CFR 888:3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MQV Dated: November 17, 2006 Received: November 20, 2006 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, 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. {3}------------------------------------------------ # Page 2 – Mr. Christopher W. Talbot 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. 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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Barbara Muchw Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ V. Indications for Use - Statement 510(k) Number (if known): K061982 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., extremities, 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 is resorbed/remodeled and is replaced by host bone during the healing process. Prescription Use × (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) Barbara Melum (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K061982 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBP/K061982](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MBP/K061982) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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