(147 days)
Not Found
No
The summary describes a traditional interbody fusion device made of titanium alloy, with no mention of AI or ML capabilities in its design, function, or intended use.
Yes
The device is indicated for use in treating Degenerative Disc Disease (DDD) and involves surgical implantation for fusion, which aims to alleviate pain and improve patient function by restoring structural integrity.
No
The device is an interbody fusion device, a type of implant used in spinal surgery to fuse vertebrae. Its purpose is treatment, not diagnosis, as it is implanted in patients to address Degenerative Disc Disease after diagnosis has already occurred through patient history and radiographic studies.
No
The device is a physical implant made of titanium alloy, intended for surgical implantation in the spine. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical implantation in the spine to treat Degenerative Disc Disease. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant made of titanium alloy, designed to be placed between vertebrae. This is consistent with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant used in a therapeutic procedure.
N/A
Intended Use / Indications for Use
The ENDOSKELETON® TO Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2- S1. 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 device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
This traditional 510(k) is intended to add additional products to the Endoskeleton® TO System that have been additively manufactured from titanium alloy.
The Endoskeleton® TO Interbody Fusion Device implants are available in a variety of sizes for treatment in Posterior Lumbar Interbody Fusion (PLIF) to accommodate patient anatomy and are designed with a large hollow region in the center to house autograft bone material. The Endoskeleton® TO Interbody Fusion Device is offered with or without nanoLOCK® Surface Technology. The nanoLOCK® Surface Technology is identical to the previously cleared product (K141953), which is a microscopic roughened surface with nano-scale features. The version without nanoLOCK® Surface Technology has a macro surface roughness.
The implant system must be used with supplemental fixation for stabilizing the implants when placed in the interbody space.
The implants are composed of medical grade titanium alloy (Ti 6Al-4V ELI) per ASTM F136 and ASTM F3001.
The components included in this submission for additive manufacturing are sterile only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1
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 was performed to demonstrate substantial equivalence in mechanical strength between the devices previously cleared and the subject devices that are additively manufactured. The following mechanical testing was conducted: Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, and Static Torsion per ASTM F2077; Subsidence per ASTM F2267, and Expulsion. Biocompatibility and cleaning validations were completed in compliance with ISO 10993. Finally, bacterial endotoxin testing was conducted compliant to AAMI ST72. The testing supports that the Endoskeleton® TO devices are adequate for the intended use and substantially equivalent to the predicate systems.
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.
K141953, K102067, K150481, K160125, P960025, P950019
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2017
Titan Spine, LLC % Ms. Christine Scifert Executive VP MRC/X. LLC 6075 Poplar Ave. Memphis. Tennessee 38119
Re: K170399
Trade/Device Name: Endoskeleton® TO Interbody Fusion Device (IBD) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: May 31, 2017 Received: June 5, 2017
Dear Ms. Scifert:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/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.
Vincent J. Devlin -S
for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170399
Device Name
Endoskeleton® TO Interbody Fusion Device (IBD)
Indications for Use (Describe)
The ENDOSKELETON® TO Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2?S1. 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 nor to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
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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510(k) Summary
Endoskeleton® TO Interbody Fusion Device (IBD) System July 5, 2017
| Company: | Titan Spine, LLC
6140 W. Executive Drive, Suite A
Mequon, WI 53092, USA |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration: | 3006340236 |
| Primary Contact: | Christine Scifert
Phone: 901-831-8053 |
| Company/Secondary
Contact: | Jane Rodd
Phone: 866-822-7800
Fax: 262-242-7802 |
| Trade Name: | Endoskeleton® TO Interbody Fusion Device (IBD) |
| Common Name: | Intervertebral fusion device with bone graft, lumbar |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | 87- Orthopedic |
| Product Code: | MAX |
| Primary Predicate: | Titan Spine, LLC Endoskeleton® TO Interbody Fusion Device
(IBD) (K141953) |
| Secondary Predicates: | Titan Spine, LLC Endoskeleton® TO Interbody Fusion Device
(IBD) (K102067)
K2M, Inc Cascadia Interbody System (K150481 & K160125)
DePuy Spine Brantigen Lumbar I/F Cage® with VSP® Spine
System (P960025)
Surgical Dynamics Ray Threaded Fusion Cage (P950019) |
4
Device Description:
This traditional 510(k) is intended to add additional products to the Endoskeleton® TO System that have been additively manufactured from titanium alloy.
The Endoskeleton® TO Interbody Fusion Device implants are available in a variety of sizes for treatment in Posterior Lumbar Interbody Fusion (PLIF) to accommodate patient anatomy and are designed with a large hollow region in the center to house autograft bone material. The Endoskeleton® TO Interbody Fusion Device is offered with or without nanoLOCK® Surface Technology. The nanoLOCK® Surface Technology is identical to the previously cleared product (K141953), which is a microscopic roughened surface with nano-scale features. The version without nanoLOCK® Surface Technology has a macro surface roughness.
The implant system must be used with supplemental fixation for stabilizing the implants when placed in the interbody space.
The implants are composed of medical grade titanium alloy (Ti 6Al-4V ELI) per ASTM F136 and ASTM F3001.
The components included in this submission for additive manufacturing are sterile only.
Indications for Use:
The ENDOSKELETON® TO Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2- S1. 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 device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Substantial Equivalence:
The subject Endoskeleton® TO IBD is comprised of additively manufactured implants as a line addition to Titan Spine's previously cleared Endoskeleton® TO IBD (K102067) and Endoskeleton® TO IBD with nanoLOCK®(K141953). The subject IBD implants will only be offered sterile and will have part numbers with both the manufactured macro roughened surface and nanoLOCK® Surface Technologies.
The subject components are substantially equivalent to the predicate Endoskeleton® TO System implants. The subject components are also similar in indications, geometry, and additive manufacturing to the secondary predicate K2M Cascadia Interbody System (K150481 & K160125). Additional predicates included the DePuy Spine Brantigen Lumbar I/F Cage® with VSP® Spine System (P960025) and Surgical Dynamics Ray Threaded Fusion Cage (P950019).
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Technological Characteristics
There are no changes between the predicate devices and the subject devices with respect to indications for use, overall design, and materials. The only difference to the currently marketed devices is the change in manufacturing process.
Performance Testing:
Mechanical testing was performed to demonstrate substantial equivalence in mechanical strength between the devices previously cleared and the subject devices that are additively manufactured. The following mechanical testing was conducted: Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, and Static Torsion per ASTM F2077; Subsidence per ASTM F2267, and Expulsion. Biocompatibility and cleaning validations were completed in compliance with ISO 10993. Finally, bacterial endotoxin testing was conducted compliant to AAMI ST72. The testing supports that the Endoskeleton® TO devices are adequate for the intended use and substantially equivalent to the predicate systems.
Conclusion:
The subject Endoskeleton® TO IBD is comprised of additively manufactured implants as a line addition to Titan Spine's previously cleared Endoskeleton® TO IBD (K102067) and Endoskeleton® TO IBD with nanoLOCK®(K141953). The testing supports that the Endoskeleton® TO devices are adequate for the intended use and substantially equivalent to the predicate systems. Specifically, the Endoskeleton® TO System implants were determined to be substantially equivalent the predicate Endoskeleton® TO System implants. The subject components are also similar in indications, geometry, and additive manufacturing to the secondary predicate K2M Cascadia Interbody System (K150481 & K160125). Additional predicates included the DePuy Spine Brantigen Lumbar I/F Cage® with VSP® Spine System (P960025) and Surgical Dynamics Ray Threaded Fusion Cage (P950019).