(120 days)
No
The summary describes a physical implant device (vertebral body replacement system) made of Carbon/PEEK and titanium. There is no mention of software, algorithms, image processing, or any terms related to AI/ML in the intended use, device description, or performance studies.
Yes
This device is intended to replace diseased or damaged vertebral bodies and restore spinal column integrity, which are therapeutic actions.
No
Explanation: The KONG®-C VBR System and KONG®-TL VBR System are described as vertebral body replacement systems, intended for surgical implantation to restore spinal column integrity. They are therapeutic devices, not diagnostic devices which are used to identify or detect medical conditions.
No
The device description explicitly states the device is manufactured from physical materials (carbon fiber reinforced PEEK and titanium coating) and is provided sterile, indicating it is a physical implant, 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 describes a surgical implant designed to replace damaged vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of carbon fiber reinforced PEEK and titanium, intended for surgical implantation. This is consistent with a medical device used for structural support and reconstruction, not for testing samples outside the body.
- No mention of in vitro testing: There is no mention of analyzing samples (like blood, urine, tissue) outside the body to diagnose a condition, which is the core function of an IVD.
The device is a vertebral body replacement system, which falls under the category of surgical implants.
N/A
Intended Use / Indications for Use
Cervical
KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Thoracolumbar
KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Product codes (comma separated list FDA assigned to the subject device)
MOP, PLR (from page 0)
MQP, PLR (from page 4)
Device Description
The KONG®-TL VBR System and the KONG®-C VBR System are vertebral body replacement systems designed to improve the stability of the cervical and thoracolumbar spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/ PEEK. BlackArmor®) and incorporate a rough titanium coating (Ti-TT®). The devices are intended to be used with supplemental spinal fixation.
Each implant is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (from C2 to T1), Thoracolumbar spine (T1 to L5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
The non-clinical tests performed by the company include static and dynamic compression, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing of the worst-case construct. The results of the performed tests demonstrate that the KONG®-C VBR System and the KONG®-TL VBR System are substantially equivalent to legally marketed predicate devices.
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.
Omnia Medical VBR (K191778), NuVasive Monolith Cervical Corpectomy System (K180550), Ulrich Small VBR (K192117), Solidity™ Vertebral Body Replacement (K181921), CAPRI Corpectomy Cage System (K180665), Obelisc Vertebral Body Replacement Device (K060416), Synthes CRL System (K103320)
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.
icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545), icotec Interbody Cage System (K172480)
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 29, 2020
icotec ag % Mr. Samuel Pollard Associate Director, Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K200235
Trade/Device Name: KONG-TL® VBR System, KONG-C® VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MOP, PLR Dated: May 7, 2020 Received: May 7, 2020
Dear Mr. Pollard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200235
Device Name
KONG®-TL VBR System and KONG®-C VBR System
Indications for Use (Describe)
Cervical
KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Thoracolumbar
KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
| 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) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
K200235 - 510(k) Summary
| Device Trade Name: | KONG®-TL VBR System and
KONG®-C VBR System |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | icotec ag
Industriestrasse 12
9450 Altstätten
Switzerland |
| Contact: | Ms. Marina Hess
CQO/Management Representative
icotec ag
Industriestrasse 12
9450 Altstätten, Switzerland
Phone: +41 71 757 0024
Fax: +41 71 757 0001
marina.hess@icotec.ch |
| Prepared by: | Mr. Samuel Pollard
Associate Director, Regulatory Affairs
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20005
Phone: 202.552.5819
Fax: 202.552.5798
spollard@mcra.com |
| Date Prepared: | January 30, 2020 |
| Classification:
Class: | 21 CFR §888.3060, Spinal intervertebral body fixation orthosis
II |
| Product Code: | MQP, PLR |
| Primary Predicates: | Omnia Medical VBR (K191778), |
| Additional Predicates: | NuVasive Monolith Cervical Corpectomy System (K180550), Ulrich
Small VBR (K192117), Solidity™ Vertebral Body Replacement
(K181921), CAPRI Corpectomy Cage System (K180665), Obelisc
Vertebral Body Replacement Device (K060416), Synthes CRL
System (K103320) |
| Reference Devices: | icotec VADER®one Pedicle System MIS and LightMore® Pedicle
System 6.0 (K190545), icotec Interbody Cage System (K172480) |
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Indications for Use:
Cervical
KONG®-C VBR System devices are intended for use in the cervical spine (from C2 to T1) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. KONG®-C VBR System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Thoracolumbar
KONG®-TL VBR System devices are intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). When used in the thoracolumbar spine, the KONG®-TL VBR System is intended to be used with FDA-cleared supplemental fixation appropriate for the implanted level, including icotec Pedicle Screw Systems.
These implants may be used with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft. These implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
Device Description:
The KONG®-TL VBR System and the KONG®-C VBR System are vertebral body replacement systems designed to improve the stability of the cervical and thoracolumbar spine. The devices are manufactured from high strength carbon fiber reinforced polyetheretherketone (Carbon/ PEEK. BlackArmor®) and incorporate a rough titanium coating (Ti-TT®). The devices are intended to be used with supplemental spinal fixation.
Each implant is provided sterile and is available in an assortment of heights, footprints, and lordosis angles to accommodate patient anatomy.
Primary Predicate Devices:
The KONG®-TL VBR System and the KONG®-C VBR System is substantially equivalent to the Omnia Medical VBR (K191778).
Additional Predicate Devices:
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- NuVasive Monolith Cervical Corpectomy System (K180550) ●
- Ulrich Small VBR (K192117)
- SolidityTM Vertebral Body Replacement (K181921)
- CAPRI Corpectomy Cage System (K180665)
- Obelisc Vertebral Body Replacement Device (K060416)
- Synthes XRL System (K103320)
Reference Devices:
The following devices are used as reference devices throughout this submission:
- icotec VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 0 (K190545).
- icotec Interbody Cage System (K172480)
Performance Testing Summary:
The non-clinical tests performed by the company include static and dynamic compression, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing of the worst-case construct. The results of the performed tests demonstrate that the KONG®-C VBR System and the KONG®-TL VBR System are substantially equivalent to legally marketed predicate devices.
Technological Characteristics:
the KONG®-C VBR System and the KONG®-TL VBR System possesses the same technological characteristics as one or more of the predicate devices. These characteristics include, the basic design (expanding corpectomy spacer), the carbon fiber reinforced polyetheretherketone (Carbon/PEEK, BlackArmor®) and a rough titanium coating (Ti-iT®), the endplate sizes (dimensions are comparable to those offered by predicate systems), the spiked design (the spiked feature is seen among multiple VBR system endplates) and the fundamental scientific technology.
Substantial Equivalence:
The subject devices were demonstrated to be substantially equivalent to predicates cited in the above with respect to indications, design, materials, function, manufacturing, and performance. The nonclinical tests performed by the include static and dynamic compression, static and dynamic torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing of the worst-case construct. The results of the performed tests demonstrate that the KONG®-C VBR System and the KONG®-TL VBR System is substantially equivalent to legally marketed predicate devices.
Conclusion:
The purpose of the traditional 510(k) is to receive regulatory clearance to introduce the KONG® TL VBR System and the KONG®-C VBR System to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate devices.