(412 days)
Not Found
No
The summary describes a physical interbody fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for use in treating degenerative disc disease, which involves alleviating pain and restoring spinal stability, thus serving a therapeutic purpose.
No
This device is an interbody fusion device, indicated for treating degenerative disc disease by providing spinal stability. It is a therapy device, not a diagnostic tool.
No
The device description explicitly states it is comprised of physical implants and associated instrumentation made of titanium alloy and PEEK, which are hardware components.
Based on the provided information, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Frontier LLC Interbody Fusion Device is an implantable device used in spinal surgery to treat Degenerative Disc Disease. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the Frontier LLC Interbody Fusion Device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Frontier LLC is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. The body of the implant includes size ranges of 8-16mm wide, 18mm high and lengths of 40-60mm. There are five sizes of locking plates and 5 sizes of corresponding screws. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and PEEK Optima LT1. The implant is available with no lordosis built into the implant design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-L5
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)
Static and dynamic axial compression, static and dynamic compression shear, and static torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Frontier LLC Interbody Fusion Device indicated that the Frontier LLC Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.
Cadaveric testing was conducted to demonstrate implantation safety, stability, and freedom from loosening or dislodgement of the implant.
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.
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
KII2700
NOV 1 200
510(k) SUMMARY Frontier Medical's Lateral Locking Cage (LLC) Interbody Fusion Device
Date: Contact: Trade Name: Product Class: Classification: Product Codes:
May 31, 2012 Matthew Songer, M.D. Frontier Medical, LLC President 512 Fourth Streets 906-232-1200 Gwinn, MI 49841 Frontier LLC Interbody Fusion Device Class II 21 CFR §888.3080 Orthosis, intervertebral body fusion device OVD 87
Name of Device and Name/Address of Sponsor
Frontier Medical, LLC 512 Fourth Street Gwinn, MI 49841
Panel Code:
Common or Usual Name Intervertebral body fusion device
Predicate Devices
The Frontier LLC was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices are the CoRoent XL-Keeled Device (K081611), and the Medtronic Clydesdale (K100175).
Intended Use / Indications for Use
The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
Technological Characteristics
The Frontier LLC is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. The body of the implant includes size ranges of 8-16mm wide, 18mm high and lengths of 40-60mm. There are five sizes of locking plates and 5 sizes of corresponding screws. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) and PEEK Optima LT1. The implant is available with no lordosis built into the implant design.
Performance Data
Static and dynamic axial compression, static and dynamic compression shear, and static torsion were completed following ASTM F2077-03. Subsidence was tested following ASTM F2267-04. Expulsion testing was conducted following a recognized protocol to allow comparison evaluation of intervertebral
•
2
1
body fusion device assemblies, and characterize their resistance to expulsion. The above pre-clinical testing performed on the Frontier LLC Interbody Fusion Device indicated that the Frontier LLC Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use.
Cadaveric testing was conducted to demonstrate implantation safety, stability, and freedom from loosening or dislodgement of the implant.
Summary:
The Frontier LLC Interbody Fusion Device and predicate devices have intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Frontier LLC Interbody Fusion Device are the same as the predicate devices. Moreover, the device is very similar in its size to the predicate device. The materials used are also the same as in the predicate device. Furthermore, bench testing and cadaveric demonstrates that these differences do not adversely impact device performance.
Conclusion:
Frontier Medical Devices concludes that the LLC Interbody Fusion Device is substantially equivalent to the predicate devices.
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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 consists of a stylized representation of a human figure embracing the world, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the emblem. The emblem is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Letter Date: November 1, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Frontier Medical Devices, Incorporated % Silver Pine Consulting, LLC Mr. Rich Jansen, Pharm. D. Regulatory Consultant 13540 Guild Avenue Apple Valley, Minnesota 55124
Re: K112700
Trade/Device Name: Frontier Lateral Locking Cage (Frontier LLC) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: October 19, 2012 Received: October 19, 2012
Dear Mr. Jansen:
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
3
Page 2 - Mr. Rich Jansen, Pharm. D.
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 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/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
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K112700 Device Name: Frontier Lateral Locking Cage (Frontier LLC)
Indications for Use:
The Frontier LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-L5. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation (i.e. lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
Prescription Use V (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)
Concurrenee of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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