(147 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, the Endoskeleton® TO Interbody Fusion Device (IBD). This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through clinical trials with defined acceptance criteria and human performance metrics.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable to this type of submission. The information provided primarily details mechanical testing to ensure the new manufacturing process (additive manufacturing) does not compromise the device's structural integrity compared to its predicate devices.
However, I can extract information related to the performance testing and its conclusions:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | The additively manufactured Endoskeleton® TO Interbody Fusion Device implants must demonstrate mechanical strength equivalent to the predicate devices (Endoskeleton® TO IBD (K102067) and Endoskeleton® TO IBD with nanoLOCK® (K141953)) when subjected to various loading conditions according to relevant ASTM standards. | All mechanical testing (Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, Dynamic Compression Shear, Static Torsion per ASTM F2077; Subsidence per ASTM F2267, and Expulsion) supported that the Endoskeleton® TO devices are adequate for the intended use and substantially equivalent to the predicate systems. |
| Biocompatibility | The device must be biocompatible according to international standards (ISO 10993). | Biocompatibility validations were completed in compliance with ISO 10993. |
| Cleaning Validation | The sterilization and cleaning process must be validated. | Cleaning validations were completed in compliance with ISO 10993. |
| Bacterial Endotoxin | The device must meet bacterial endotoxin limits according to AAMI ST72. | Bacterial endotoxin testing was conducted compliant to AAMI ST72. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each mechanical test. However, it indicates these were bench tests (mechanical, biocompatibility, cleaning, endotoxin) performed on physical device samples. Therefore, the "data provenance" is derived from these laboratory tests rather than patient data (e.g., country of origin of data, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as the submission relies on objective mechanical and material science testing against established standards, not interpretation by clinical experts to establish a "ground truth."
4. Adjudication Method
This is not applicable for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or mentioned. This type of study is typically relevant for diagnostic imaging devices where human interpretation is a key component. This device is an implantable surgical device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This is not applicable. The device is an implantable medical product, not an algorithm, and does not involve human-in-the-loop performance in the context of its function.
7. Type of Ground Truth Used
The "ground truth" used for this submission is based on:
- Established ASTM (American Society for Testing and Materials) standards for mechanical testing.
- ISO (International Organization for Standardization) standards (ISO 10993) for biocompatibility and cleaning validation.
- AAMI (Association for the Advancement of Medical Instrumentation) standard (AAMI ST72) for bacterial endotoxin testing.
The "ground truth" is that the new, additively manufactured device performs mechanically and biologically equivalently to the predicate devices as demonstrated by adherence to these industry and regulatory standards.
8. Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an implantable medical device submission of this nature. Machine learning or AI models, which would require training sets, are not involved.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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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
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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, LLC6140 W. Executive Drive, Suite AMequon, WI 53092, USA |
|---|---|
| EstablishmentRegistration: | 3006340236 |
| Primary Contact: | Christine ScifertPhone: 901-831-8053 |
| Company/SecondaryContact: | Jane RoddPhone: 866-822-7800Fax: 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® SpineSystem (P960025)Surgical Dynamics Ray Threaded Fusion Cage (P950019) |
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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).
§ 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.