(195 days)
No
The 510(k) summary describes a physical interbody spacer device and its mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a cervical interbody spacer used in spinal fusion procedures to treat degenerative disc disease, which involves a therapeutic intervention to alleviate neck pain and promote fusion.
No
The device is an interbody spacer, intended for spinal fusion procedures. This is a therapeutic device, not a diagnostic one. Its purpose is to physically treat a condition (degenerative disc disease) by fusing vertebrae, not to identify or characterize it.
No
The device description clearly states it is a "cervical interbody fusion device" with physical characteristics like "teeth" and varying "size footprints" and "heights". The performance studies also describe physical testing (compression, torsion, subsidence, expulsion, wear) which are relevant to a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Latitude-C Interbody Spacer is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebrae, not a diagnostic test.
The information provided describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Latitude-C Interbody Spacer is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C Interbody Spacer in the cervical spine.
Product codes
ODP
Device Description
DeGen Medical Latitude-C Cervical Interbody Spacer is a cervical interbody fusion device for anterior cervical fusion procedures. The Latitude-C spacer has teeth on its superior and inferior surfaces to prevent migration. The Latitude-C spacer comes in 5 different size footprints, and different heights ranging from 5mm to 14mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1)
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)
Non-clinical testing was performed to demonstrate the DeGen Medical Latitude-C Cervical Interbody Spacer is substantially equivalent to other predicate devices in accordance with “Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s”, May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 12, 2007.
The following tests were performed:
Static and dynamic compression testing per ASTM F2077 Static and dynamic torsion testing per ASTM F2077 Subsidence testing via ASTM F2267 Expulsion Testing Wear testing per ASTM F1877 Additional tests were included on the coating:
Static Tensile Strength Static Shear Strength Abrasion Resistance Shear Fatigue The results of these studies show the subject DeGen Medical Latitude-C Cervical Interbody Spacer meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K133967, K142026, K103488, P980048
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract image of a bird-like figure, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2015
DeGen Medical % Linda Braddon, Ph.D. President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K151496
Trade/Device Name: Latitude-C Cervical Interbody Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: November 12, 2015 Received: November 16, 2015
Dear Dr. Braddon:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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) K151496
Device Name Latitude-C Cervical Interbody Spacer System
Indications for Use (Describe)
The Latitude-C Interbody Spacer is indicated for spinal fusion procedures at one level in the cervical spine (C2-T1), in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies.
The Latitude-C Interbody Spacer is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.
Patients must have undergone a regimen of at least six weeks of non-operative treatment prior to being treated with the Latitude-C Interbody Spacer in the cervical spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for DeGen Medical. The logo consists of a blue abstract design on the left, resembling three curved lines emanating from three blue circles. To the right of the design is the text "DeGen" in a larger, bolder blue font, with the word "Medical" underneath in a smaller, gray font. The overall design is clean and professional.
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical LATITUDE-C is provided below.
| Date Summary Prepared | November 12, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | DeGen Medical |
| 1321-C North Cashua Drive | |
| Florence, SC 29501 | |
| Phone 877-240-7838 | |
| Fax 843-407-0545 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| LGB@SecureBME.com | |
| Trade Name | Latitude-C Cervical Interbody Spacer System |
| Latitude-C PEEK Cervical Interbody Spacer | |
| Latitude-C Porous Ti Cervical Interbody Spacer | |
| Latitude-C HA PEEK Cervical Interbody Spacer | |
| Latitude-C CFR Cervical Interbody Spacer | |
| Latitude-C Ti Cervical Interbody Spacer | |
| Common Name | Intervertebral body fusion device |
| Code -Classification | ODP |
| 21 CFR 888.3080 : Class II | |
| Primary Predicate | K142152 – CONSTRUX Mini PEEK Spacer System |
| Reference Devices | K133967 - Aurora Spine Interbody Fusion System |
| K142026 - Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device | |
| K103488 – Depuy Spine Bengal Spine System | |
| P980048 - BAK/Cervical Interbody Fusion System | |
| Device Description | DeGen Medical Latitude-C Cervical Interbody Spacer is a cervical |
| interbody fusion device for anterior cervical fusion procedures. The | |
| Latitude-C spacer has teeth on its superior and inferior surfaces to | |
| prevent migration. The Latitude-C spacer comes in 5 different size | |
| footprints, and different heights ranging from 5mm to 14mm. | |
| Indications for Use | The Latitude-C Interbody Spacer is indicated for spinal fusion procedures |
| at one level in the cervical spine (C2-T1), in skeletally mature patients | |
| with degenerative disc disease. Degenerative disc disease is defined as | |
| neck pain of discogenic origin with degeneration of the disc confirmed by | |
| patient history and radiographic studies. |
The Latitude-C Interbody Spacer is intended for use with autograft and/or
allograft comprised of cancellous and/or corticocancellous bone graft
and supplemental fixation, eg. Hyper-C Anterior Cervical Plate System.
Patients must have undergone a regimen of at least six weeks of non-
operative treatment prior to being treated with the Latitude-C Interbody
Spacer in the cervical spine. |
| Technological Characteristics | As was established in this submission, the subject Latitude-C Cervical
Interbody Spacer is substantially equivalent to other predicate devices
cleared by the FDA for commercial distribution in the United States. The
subject device was shown to be substantially equivalent and has the same
technological characteristics to its predicate devices through comparison
in areas including design, intended use, material composition, function,
and range of sizes. |
| Non-Clinical Performance Testing Conclusion | Non-clinical testing was performed to demonstrate the DeGen Medical
Latitude-C Cervical Interbody Spacer is substantially equivalent to other
predicate devices in accordance with “Guidance for Industry and FDA
Staff, Guidance for Spinal System 510(k)s”, May 3, 2004 and Class II Special
Controls Guidance Document: Intervertebral Body Fusion Device, June 12,
2007.
The following tests were performed:
Static and dynamic compression testing per ASTM F2077 Static and dynamic torsion testing per ASTM F2077 Subsidence testing via ASTM F2267 Expulsion Testing Wear testing per ASTM F1877 Additional tests were included on the coating:
Static Tensile Strength Static Shear Strength Abrasion Resistance Shear Fatigue The results of these studies show the subject DeGen Medical Latitude-C
Cervical Interbody Spacer meets or exceeds the performance of the
predicate devices, and the device was therefore found to be substantially
equivalent. |
| Substantial Equivalence
Summary (Conclusion) | Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject DeGen Medical Latitude-C Cervical Interbody Spacer has been shown to be substantially equivalent to legally marketed predicate devices. |
4
Image /page/4/Picture/0 description: The image shows the logo for DeGen Medical. The logo consists of a blue abstract design on the left and the words "DeGen Medical" on the right. The word "DeGen" is in a larger, bolder, blue font, while the word "Medical" is in a smaller, lighter gray font.
5
Image /page/5/Picture/0 description: The image shows the logo for DeGen Medical. The logo consists of a blue abstract design on the left and the words "DeGen Medical" on the right. The abstract design features three curved lines with circles at the end, and the words "DeGen Medical" are written in blue, with "Medical" in a smaller font size.