(67 days)
No
The document describes a physical intervertebral body fusion device and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an intervertebral body fusion device used to facilitate fusion in the lumbar spine for patients with degenerative disc disease, which addresses a medical condition.
No
Explanation: The device is an intervertebral body fusion device (an implant) and its purpose is to facilitate fusion, not to diagnose a medical condition. While degenerative disc disease confirmed by radiographic studies is part of the indication for use, the device itself is a treatment, not a diagnostic tool.
No
The device description clearly states it is comprised of physical implants (intervertebral body fusion devices) made of specific lengths, heights, and lordosis, and describes mechanical bench testing. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The TELIX K Interbody System is a physical implant designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not in vitro (in a test tube or lab setting).
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by implanting a device into the spine.
- Performance Studies: The performance studies described are mechanical bench tests evaluating the physical properties and strength of the implant, not diagnostic tests on biological samples.
Therefore, the TELIX K Interbody System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).
Patients should have six months of non-operative treatment prior to surgery.
These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.
These implants are intended for use with Biedermann Motech supplemental internal fixation products.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants:
The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm.
Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis.
The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation.
The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
lumbar region (L2-L5) and sacral region (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)
Non-Clinical Test Summary
The TELIX K Interbody System was evaluated per the FDA Guidance Document for Industry and FDA Staff; Class II Special Controls Guidance Document Intervertebral Body Fusion Device.
The following testing was done to show substantial equivalence of our system:
Bench testing - mechanical
Mechanical testing according to ASTM F2077-14 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 standard (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) was performed in order to provide data to support a substantial equivalence determination. These tests were performed to support system related performance under consideration of well-established acceptance criteria. Performance testing included:
- Static Compression
- Dynamic Compression
- Static Torsion
- Static Compression-Shear ■
- Dynamic Compression-Shear ■
- Subsidence
Result: The results of the worst case biomechanical testing of the TELIX K Interbody System indicate that the system is substantially equivalent to the identified predicate/reference devices.
Clinical Test Summary
No clinical tests were performed.
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.
Depuy Spine Devex System - DePuy Spine, Inc (K081917)
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.
Aleutian IBF System – K2M, Inc. (K082698), MectaLIF - Medacta International (K110927), T-PAL Spacer System - Synthes USA Products LLC (K162358)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biedermann Motech GmbH & Co. KG Mr. Gerd Federle Director of Quality Management Bertha-von-Suttner-Str. 23 78054 Villingen-Schwenningen GERMANY
June 2, 2017
Re: K170890
Trade/Device Name: TELIX K Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 24, 2017 Received: March 27, 2017
Dear Mr. Federle:
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 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.
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) K170890
Device Name TELIX K Interbody System
Indications for Use (Describe)
The TELIX K Interbody System is intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).
Patients should have six months of non-operative treatment prior to surgery.
These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.
These implants are intended for use with Biedermann Motech supplemental internal fixation products.
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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Image /page/3/Picture/2 description: The image shows a logo with the word "BIEDERMANN" on the top line and "MOTECH" on the bottom line. The letters in "MOTECH" are spaced out. There is a black square in the upper right corner of the logo.
510(k) Summary
1. Submitter, Correspondent and Manufacturer
| Submitter Name: | Biedermann Motech GmbH & Co. KG |
|---|---|
| Submitter Address: | Bertha-von-Suttner-Str. 23 |
| 78054 Villingen-Schwenningen | |
| Germany | |
| Contact Person: | Gerd Federle |
| Director of Quality Management | |
| Phone: +49 7720 8510-545 | |
| Fax: +49 7720 8510-66 | |
| gfe@biedermann.com | |
| Date of Submission: | 03/24/2017 |
| Manufacturer Name: | Biedermann Motech GmbH & Co. KG |
| Manufacturer Address: | Bertha-von-Suttner-Str. 23 |
| 78054 Villingen-Schwenningen | |
| Germany |
2. Device Identification
| Device Trade Name: | TELIX K Interbody System |
|---|---|
| Device Common Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification Name: | Intervertebral Body Fusion with Bone Graft, Lumbar |
| Classification Code: | MAX, Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3080 |
| Regulation Name: | Intervertebral body fusion device |
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Image /page/4/Picture/2 description: The image shows a logo with the text "BIEDERMANN" on one line and "MOTECN" on the line below. The text is located in the bottom left corner of a square. A black square is located in the upper right corner of the larger square, partially obscuring the text.
3. Predicate Device
| Predicate Device: | Depuy Spine Devex System - DePuy Spine, Inc (K081917) |
|---|---|
| Reference Devices: | Aleutian IBF System – K2M, Inc. (K082698) |
| – MectaLIF - Medacta International (K110927) |
- | T-PAL Spacer System - Synthes USA Products LLC (K162358)
4. Device Description
The TELIX K Interbody System is intended for use as an intercorporal fusion cage in the lumbar region (L2-L5) and sacral region (S1). Therefore, the system includes the following implants:
The TELIX K Interbody System is comprised of slightly curved implants in lengths of 28, 32 and 36mm and heights ranging from 7 to 17mm.
Devices that are 7mm in thickness are only available with 0-degrees of lordosis and all other implants possess 5-degrees of lordosis.
The implants are introduced via a TLIF approach using autogenous bone. The TELIX K Interbody System must only be implanted in combination with supplemental fixation.
The implants of the TELIX K Interbody System are single-use only and the system is provided non sterile.
5. Material
The implants are manufactured from ASTM F 136 implant grade titanium alloy Ti-6AI-4V ELI.
6. Indications for Use
The TELIX K Interbody System is indicated for use as intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1).
Patients should have six months of non-operative treatment prior to surgery.
5
Image /page/5/Picture/2 description: The image shows a logo with the text "BIEDERMANN" stacked on top of "MOTEC H". The text is in a sans-serif font and is aligned to the left. There is a black square in the upper right corner of the logo, partially obscuring the top right corner of the square border around the logo.
These implants are used to facilitate fusion in the lumbar spine and are placed via a TLIF approach using autogenous bone.
These implants are intended for use with Biedermann Motech supplemental internal fixation products.
7. Technological Characteristics and Substantial Equivalence
Like the predicate device (DEVEX System – K081917) the TELIX K Interbody System consists of cages that are available in varying sizes to fit the patient's anatomical and physiological requirements.
The TELIX K cages are of a similar design and made from Titanium alloy Ti-6Al-4V, as the predicate is.
The System is intended to provide intervertebral body fusion in skeletally mature patients, as the predicate is.
8. Performance Data
8.1 Non-Clinical Test Summary
The TELIX K Interbody System was evaluated per the FDA Guidance Document for Industry and FDA Staff; Class II Special Controls Guidance Document Intervertebral Body Fusion Device.
The following testing was done to show substantial equivalence of our system:
Bench testing - mechanical
Mechanical testing according to ASTM F2077-14 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 standard (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) was performed in order to provide data to support a substantial equivalence determination. These tests were performed to support system related performance under consideration of well-established acceptance criteria. Performance testing included:
- Static Compression
- Dynamic Compression
- Static Torsion
- Static Compression-Shear ■
- Dynamic Compression-Shear ■
- Subsidence
6
Result: The results of the worst case biomechanical testing of the TELIX K Interbody System indicate that the system is substantially equivalent to the identified predicate/reference devices.
8.2 Clinical Test Summary
No clinical tests were performed.
9. Substantial Equivalence Summary and Conclusion
There are no differences between the devices which would raise new concerns regarding safety or effectiveness.
Based on available 510(k) information provided, comparison to predicate devices and performance testing, the TELIX K Interbody System can be considered substantially equivalent to the predicate/reference devices.