(293 days)
BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hydroxyapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.
The provided text describes a 510(k) summary for a medical device called osteoSPAN Morpheus, a resorbable calcium salt bone void filler. The submission does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on:
- Technological characteristics comparison: A table comparing osteoSPAN Morpheus to a primary predicate (osteoSPAN granules) and a material-reference predicate (Actifuse ABX E-Z-fil Putty) across several characteristics (Calcium Salt, Granule Size, Porosity, Polymer Binder, Osteoconductive).
- Safety and performance testing: "Chemical and physical testing confirmed acceptable findings and were consistent with prior osteoSPAN predicate device qualifications. Biogennix osteoSPAN Morpheus was thoroughly evaluated for biocompatibility in accordance with ISO 10993 appropriate parts and for performance, through multiple non-clinical in-vivo and ex-vivo studies."
Since this is a conventional medical device submission rather than an AI/ML device, the specific questions regarding AI/ML device performance (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this document.
Therefore, I cannot provide the requested information from the given text.
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510(K) SUMMARY
Submitted on behalf of:
BIOGENNIX, LLC Company Name: 18011 Sky Park Circle, Ste M Address: Irvine, CA 92614 949-253-0094 Telephone: Fax: 949-266-5800 Elaine Duncan, M.S.M.E., RAC by: President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 Telephone: 715-549-5380 Fax: CONTACT PERSON: Elaine Duncan May 12, 2014 DATE PREPARED: osteoSPAN Morpheus TRADE NAME: bone void filler COMMON NAME: 21 CFR 888.3045: CLASSIFICATION NAME:
PRO CODE:
Resorbable calcium salt bone void-filler device MQV
DESCRIPTION of the DEVICE:
osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hydroxyapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.
INDICATIONS FOR USE:
BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created
MAY 2 0 2014
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510(k) Summary-Continued
from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
| Product | Calcium Salt | GranuleSize | Porosity | PolymerBinder | Osteo-conductive |
|---|---|---|---|---|---|
| osteoSPANMorpheus | Calcium carbonate/calcium phosphatecomposite | 1-2mm | 65% | Yes | Yes |
| osteoSPAN(K093342) | Calcium carbonate/calcium phosphatecomposite | 1-4mm | 65% | No | Yes |
| Actifuse ABX(K071206) | Silicate substitutedcalcium phosphate | 1-2mm | 80% | Yes | Yes |
SUMMARY of HOW TECHNOLOGICAL CHARACTERISTICS COMPARE:
CONCLUSION FROM TESTING:
Chemical and physical testing confirmed acceptable findings and were consistent with prior osteoSPAN predicate device qualifications. Biogennix osteoSPAN Morpheus was thoroughly evaluated for biocompatibility in accordance with ISO 10993 appropriate parts and for performance, through multiple non-clinical in-vivo and ex-vivo studies. These studies conclusively demonstrate that osteoSPAN Morpheus is safe and performs as well as the primary predicate: osteoSPAN granules and like the material-reference: Actifuse ABX E-Z Fil Putty.
SUBSTANTIALLY EQUIVALENT TO:
The contents of this submission have demonstrated that osteoSPAN Morpheus is substantially equivalent to Biogennix osteoSPAN granules (primary predicate) (K093342) and to the material-reference predicate: Actifuse ABX E-Z-fil Putty (K071206) manufactured by Apatech, Ltd.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Flampshire Avenue Document Control Center - WO66-G609 Silver Spring, Mi) 20993-0002
May 20, 2014
Biogennix. LLC % Ms. Elaine Duncan President Paladin Medical®, Incorporated P.O. Box 560 Stillwater, Minnesota 55082
Re: K132377
Trade/Device Name: osteoSPAN Morpheus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 11, 2014 Received: April 14, 2014
Dear Ms. Duncan:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 -- Ms. Elaine Duncan
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132377
Device Name
osteoSPAN Morpheus
Indications for Use (Describe)
BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
aurence D
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§ 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.