(112 days)
Not Found
Not Found
No
The summary describes a physical implant device and its intended use, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is an implantable medical device (vertebral body replacement, intervertebral body fusion device) used to replace or fuse parts of the spine, which is a structural intervention, not a therapeutic treatment using drugs, radiation, or other active agents.
No
The device is described as an implantable vertebral body replacement and intervertebral body fusion device, not a tool for diagnosis.
No
The device description clearly states that the Mosaic device is a physical implant made from titanium alloy or PEEK, and includes bone screws. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Mosaic device is a physical implant (a vertebral body replacement or intervertebral body fusion device) made of titanium alloy or PEEK. Its intended use is to be surgically implanted into the spine to replace or fuse vertebrae.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples. It is a structural implant used in surgical procedures.
Therefore, based on the provided information, the Mosaic device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used as a vertebral body replacement, the Mosaic device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft
When used as an intervertebral body fusion device, the Mosaic device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
Spinal Elements' Mosaic device is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device body has projections (or flanges) that encompass screw holes and may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).
The Mosaic system is provided with bone screws that are manufactured from titanium alloy (Ti-6Al-4V), and are available in both fixed and variable angle designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or thoracolumbar spine (T1-L5), cervical spine (C3-C7)
Indicated Patient Age Range
skeletally mature patients
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)
Mechanical testing indicates that the Mosaic device is capable of performing in accordance with its intended use.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Spinal Elements, Inc. Premarket Notification - MosuicTM
Page 1 of 2
510(k) Summary MosaicTM
510(k) Number L071833
OCT 2 3 2007
| Manufacturer Identification | |
|---|---|
| Submitted by: | Spinal Elements, Inc. |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-0121 | |
| Contact Information: | |
| Kerri DiMartino | |
| Regulatory Affairs Specialist | |
| Spinal Elements, Inc. | |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-1816 | |
| kdimartino@spinalelements.com | |
| Date Prepared: | October 16, 2007 |
| Device Indentification | |
| Proprietary Name: | Mosaic™ |
| Common Name: | Intervertebral Body Fusion Device |
| Device Classification: | 21 CFR 888.3080 (orthosis, spinal intervertebral fusion) |
Device Description
Spinal Elements' Mosaic device is a generally box-shaped device with various holes located throughout its geometry and teeth on the superior and inferior surfaces. The device body has projections (or flanges) that encompass screw holes and may be made from titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK).
The Mosaic system is provided with bone screws that are manufactured from titanium alloy (Ti-6Al-4V), and are available in both fixed and variable angle designs.
Intended Use of the Device
When used as a vertebral body replacement, the Mosaic device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and
1
rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft
When used as an intervertebral body fusion device, the Mosaic device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Substantial Equivalence
The Mosaic device was shown to be substantially equivalent through comparison to predicate intervertebral body fusion devices.
Performance Data
Mechanical testing indicates that the Mosaic device is capable of performing in accordance with its intended use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 12 2011
Spinal Elements, Incorporated % Ms. Kerri DiMartino Regulatory Affairs Specialist 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010
Re: K071833
Trade/Device Name: Mosaic™ Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: September 14, 2007 Received: September 17, 2007
Dear Ms. DiMartino:
This letter corrects our substantially equivalent letter of October 23, 2007.
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 (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 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
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K671833
Page 1 of 1
Indications for Use
1607 1833 510(k) Number (if known):
Mosaic™M Device Name:
Indications for Use:
When used as a vertebral body replacement, the Mosaic device is intended for use in the thoracic and/or thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft
When used as an intervertebral body fusion device, the Mosaic device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Millikin
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K071833