(107 days)
Not Found
No
The description focuses on the material composition and physical properties of the bone graft substitute. There is no mention of any computational or analytical functions that would typically involve AI/ML.
Yes
The device is indicated to fill bony voids or gaps resulting from traumatic injury during the healing process, and is replaced by bone, which directly treats a condition affecting the body's structure.
No
The device is described as a bone void filler and graft substitute, which is used to replace bone and facilitate healing, not to diagnose a condition.
No
The device description clearly states it is a moldable, osteoconductive bone graft substitute composed of granules and a binder, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a bone void filler to be surgically implanted into bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and physical properties of the bone graft substitute, which is consistent with a medical device used for structural support and bone regeneration.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on bone ingrowth, tissue reaction, and mechanical strength, which are relevant to the device's function as a bone graft substitute, not a diagnostic tool.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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, posterolateral spine 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. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.
Product codes
MQV
Device Description
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 hvdroxvapatite, 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 used in osteoSPAN Morpheus 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (the extremities, posterolateral spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Supplementary preclinical performance testing confirmed that osteoSPAN Morpheus has substantially equivalent bone ingrowth, tissue reaction, mechanical strength and residual material as its predicate osteoSPAN when used in a posterolateral spine model; therefore, osteoSPAN Morpheus is substantially equivalent to the predicate device osteoSPAN when used in posterolateral spinal fusion indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Biogennix, LLC % Ms. Elaine Duncan President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082
Re: K142828
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: December 18, 2014 Received: December 19, 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
1
Page 2 - Ms. Elaine Duncan
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.
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/Resourcesfor You/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/ReportaProblem/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142828
Device Name
osteoSPAN Morpheus
Indications for Use (Describe)
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, posterolateral spine 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. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.
Type of Use (Select one or both, as applicable)
2 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) (Signature)
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510(K) SUMMARY
Submitted on behalf of:
| Company Name: | BIOGENNIX, LLC |
|---|---|
| Address: | 18011 Sky Park Circle, Ste M |
| Irvine, CA 92614 | |
| Telephone: | 949-253-0094 |
| Fax: | 949-266-5800 |
| by: | Elaine Duncan, M.S.M.E., RAC |
| President, Paladin Medical, Inc. | |
| PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | January 14, 2015 |
| TRADE NAME: | osteoSPAN Morpheus |
| COMMON NAME: | bone void filler |
| CLASSIFICATION NAME: | 21 CFR 888.3045; |
| Resorbable calcium salt bone void-filler device | |
| PRO CODE: | 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 hvdroxvapatite, 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 used in osteoSPAN Morpheus 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.
This submission expands the indication for use to include posterolateral spine.
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, posterolateral spine 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
4
filler that resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.
SUMMARY of HOW TECHNOLOGICAL CHARACTERISTICS COMPARE:
The subject device is IDENTICAL to osteoSPAN Morpheus cleared under K132377, except for an expanded indication for use in posterolateral spine fusion and updated instructions for use which now include quidelines for use in posterolateral spine fusion. The osteoSPAN predicate device (K093342) is the primary component of osteoSPAN Morpheus and has not been altered in any way: therefore, both devices have identical osteoconductive potential.
| Product | Calcium Salt | Granule
Size | Porosity | Polymer
Binder | Osteo-
conductive |
|----------------------------------|------------------------------------------------------|-----------------|----------|-------------------|----------------------|
| osteoSPAN
Morpheus
K132377 | Calcium carbonate/
calcium phosphate
composite | 1-2mm | 65% | Yes | Yes |
| osteoSPAN
(K093342) | Calcium carbonate/
calcium phosphate
composite | 1-4mm | 65% | No | Yes |
SUBSTANTIALLY EQUIVALENT TO:
The contents of this submission have demonstrated that osteoSPAN Morpheus is substantially equivalent to OsteoSPAN when used as a bone graft extender in posterolateral spine cleared under K093342 (primary predicate); and is identical to the predicate osteoSPAN Morpheus cleared under K132377. This submission does not change any aspect of the osteoSPAN Morpheus. This submission only adds the additional indication for use for osteoSPAN Morpheus.
CONCLUSION FROM TESTING:
Supplementary preclinical performance testing confirmed that osteoSPAN Morpheus has substantially equivalent bone ingrowth, tissue reaction, mechanical strength and residual material as its predicate osteoSPAN when used in a posterolateral spine model; therefore, osteoSPAN Morpheus is substantially equivalent to the predicate device osteoSPAN when used in posterolateral spinal fusion indications.