← Product Code [NDN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDN) · K080108 # CORTOSS BONE AUGMENTATION MATERIAL (K080108) _Orthovita, Inc. · NDN · Jun 5, 2009 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDN/K080108 ## Device Facts - **Applicant:** Orthovita, Inc. - **Product Code:** [NDN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDN.md) - **Decision Date:** Jun 5, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3027 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use CORTOSS® Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). ## Device Story Cortoss is an injectable, nonresorbable, resin-based bis-glycidal dimethacrylate (Bis-GMA) composite bone cement. Used by physicians in clinical settings for vertebral augmentation to treat painful vertebral compression fractures. The material is injected into the vertebral body to act as a strengthening agent for weakened bone stock or fractures. By stabilizing the fracture, the device aims to reduce pain and restore structural integrity to the vertebral body. It functions as a mechanical support material. ## Clinical Evidence Clinical safety and effectiveness evaluated in over 500 patients across 43 sites. U.S. data included two pilot studies (n=40) and one prospective, randomized, multi-center, single-blind pivotal study (n=256; 162 Cortoss, 94 control). E.U. data included a multi-center, single-arm, prospective study (n>300) with follow-up ranging from 6 months to over 3 years. ## Technological Characteristics Injectable, nonresorbable, resin-based bis-glycidal dimethacrylate (Bis-GMA) composite bone cement. Designed for vertebral augmentation. ## Regulatory Identification Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone. ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.” ## Predicate Devices - Spineplex Radiopaque Bone Cement ([K032945](/device/K032945.md)) - Spine-Fix Biomimetic Bone Cement ([K043593](/device/K043593.md)) - Staxx Fx System ([K053336](/device/K053336.md), [K063606](/device/K063606.md)) - Confidence High Viscosity Bone Cement ([K060300](/device/K060300.md)) ## 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}------------------------------------------------ ## 510(k) SUMMARY CORTOSS® Bone Augmentation Material May 28, 2009 ## 510(k) Number (if known): K080108 #### 1. Contact Person Catherine Moffa Director, Regulatory Affairs (e-mail) cmoffa@orthovita.com Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 610-640-1714 #### 2. Device Name and Classification | Product Name: | Cortoss Bone Augmentation Material | |-----------------------|------------------------------------| | Classification Name: | Cement, Bone, Vertebroplasty | | Common or Usual Name: | Vertebral Augmentation Material | | Classification Panel: | Orthopedic | | Regulation Number: | 888.3027 | | Device Class: | Class II | | Product Code: | NDN | #### 3. Substantial Equivalence Cortoss is substantially equivalent to the following medical devices in commercial distribution: | Predicate Device | Company | FDA Clearance Number | |---------------------------------------|-------------|----------------------| | Spineplex Radiopaque Bone Cement | Stryker | K032945 | | Spine-Fix Biomimetic Bone Cement | Teknimed | K043593 | | Staxx Fx System | Spine Wave | K053336, K063606 | | Confidence High Viscosity Bone Cement | Disc-O-Tech | K060300 | Cortoss has the same intended use and indications, similar technological characteristics, and similar principles of operation as its predicate devices. The minor technological differences between Cortoss and its predicate devices raise no new issues of safety or effectiveness. Performance and clinical data demonstrate that Cortoss is as safe and effective as its predicate devices. Thus, Cortoss is substantially equivalent. {1}------------------------------------------------ ## 4. Device Description Cortoss is a composite material that functions as a strengthening agent for injection into vertebral bodies with compression fractures or weakened bone stock. This injectable, nonresorbable synthetic material is generically referred to as a resin-based, bis-glycidal dimethacrylate (Bis-GMA) composite. ## 5. Indications for Use CORTOSS Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). #### 6. Performance Data Performance testing was conducted to ensure that Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices. In all instances, Cortoss functioned as intended. ## 7. Clinical Data Human clinical studies were conducted in over 500 patients at 43 clinical sites to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures. In the U.S., data was collected in 40 patients in two pilot studies and in 256 patients (162 Cortoss: 94 control) in a prospective, randomized, multi-center, pivotal, single-blind pivotal study. In the E.U., data was collected in over 300 patients, including a multi-center, single arm, prospective study. These European studies were conducted in four countries (France, Italy, Sweden and the UK), with follow-up ranging from six months to over three years. {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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Orthovita, Inc. % Ms. Catherine Moffa Director, Regulatory Affairs 45 Great Valley Parkway Malvern, Pennsylvania 19355 ## JUN - 5 2009 Re: K080108 Trade/Device Name: CORTOSS® Bone Augmentation Material Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: March 31, 2009 Received: April 1, 2009 #### Dear Ms. Moffa: 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Ms. Catherine Moffa 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information.regarding.the reporting of adverse events, please go.to http://www.fda.gov/cdrh/mdr/. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 510(k) Number (if known): K080108 ## Device Name: CORTOSS® Bone Augmentation Material # INDICATIONS FOR USE: CORTOSS® Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). Prescription 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) /// Page 1 of 1 (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K080108 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDN/K080108](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NDN/K080108) **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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