(218 days)
Not Found
No
The document describes a physical implantable device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a Cervical Interbody Fusion System intended for use in patients with degenerative disc disease to facilitate fusion, which is a therapeutic intervention.
No
The device is an interbody fusion system used for treating degenerative disc disease, not for diagnosing it. Its function is to facilitate fusion, not to determine the presence or nature of a medical condition.
No
The device description explicitly states it includes 3D-Printed (3DP) titanium interbodies and titanium alloy anchors, which are physical 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Genesys Spine 3DP Cervical Interbody Fusion System is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion.
- Intended Use: The intended use describes a surgical procedure for treating degenerative disc disease, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Genesys Spine 3DP Cervical Interbody Fusion System is a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used with the internal fixation and as a stand-alone system:
The Genesys Spine 3DP Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3DP Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.
When used without the internal fixation:
The Genesys Spine 3DP Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
The Genesys Spine 3DP Cervical Interbody System includes 3D-Printed (3DP) titanium interbodies. The 3DP Cervical Interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The version that utilizes integrated fixation may be used as a stand-alone cervical device that is implanted with two (2) titanium alloy anchors. All interbodies are made from Ti-6Al-4V ELI titanium alloy. The standalone version includes an integrated locking mechanism and various sizes of anchors which are all manufactured from Ti-6Al-4V ELI titanium alloy.
The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one level from C2-T1
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)
Performance evaluations were conducted on constructs representing the worst-case components (including static compression, static torsion, static compression shear, dynamic compression, dynamic torsion, dynamic compression shear [in accordance with ASTM F2077], subsidence [in accordance with ASTM F2267], expulsion testing, and cadaver testing. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions. The Genesys Spine 3DP Cervical Interbody System was found to be substantially the same as 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.
Genesys Spine AIS-C Cervical Stand-Alone System (Genesys Spine - K181295), 3DP Lumbar Interbody System (Genesys Spine – K182987), EIT Cellular Titanium® Cervical & Lumbar Cages (Emerging Implant Technologies – K170503), Apache® Interbody Fusion System (Genesys Spine - K103034), Apache® Cervical Interbody Fusion System (Genesys Spine - K150812), LDR Spine Cervical Interbody Fusion System (LDR Spine - K091088)
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
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January 8, 2020
Genesys Spine Mr. Benjamin Keller Product Development Engineer 1250 South Capital of Texas Highway, Building 3 Suite 600 Austin, Texas 78746
Re: K191489
Trade/Device Name: Genesys Spine 3DP Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: December 11, 2019 Received: December 13, 2019
Dear Mr. Keller:
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 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
1
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 mediation-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 L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K191489
Device Name
Genesys Spine 3DP Cervical Interbody Fusion System
Indications for Use (Describe)
When used with the internal fixation and as a stand-alone system:
The Genesys Spine 3DP Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3DP Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.
When used without the internal fixation:
The Genesys Spine 3DP Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
| 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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3
Image /page/3/Picture/1 description: The image shows the logo for Genesys Spine. The word "Genesys" is in gray, with the "G" in brown and a brown arrow pointing to the right. Below the word "Genesys" is the word "spine" in brown with the registered trademark symbol.
4. 510(K) SUMMARY
| Submitter's Name: | Genesys Spine | |
|---|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway South | |
| Building Three, Suite 600 | ||
| Austin, Texas 78746 | ||
| Contact Name: | Benjamin V. Keller (Primary) | William W. Sowers (Secondary) |
| Submitter's | ||
| Telephone: | 512-381-7093 | 512-381-7080 |
| Submitter's Fax: | 800-817-4938 | 800-817-4938 |
| Date Summary was | ||
| Prepared: | December 31st, 2019 | |
| Trade or Proprietary | ||
| Name: | Genesys Spine 3DP Cervical Interbody System | |
| Common or Usual | ||
| Name: | Intervertebral Body Fusion Device, Cervical | |
| Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical | |
| Classification: | Class II per 21 CFR §888.3080 | |
| Regulation Number: | 21 CFR 888.3080 | |
| Product Codes: | OVE, ODP | |
| Classification Panel: | Orthopedic Devices Panel | |
| Legally Marketed | ||
| (unmodified) devices | ||
| to Which Substantial | ||
| Equivalence is | ||
| Claimed: | Primary Predicate: | |
| Genesys Spine AIS-C Cervical Stand-Alone System (Genesys Spine - K181295) |
Additional Predicate Devices:
3DP Lumbar Interbody System (Genesys Spine – K182987)
EIT Cellular Titanium® Cervical & Lumbar Cages (Emerging Implant
Technologies – K170503)
Apache® Interbody Fusion System (Genesys Spine - K103034)
Apache® Cervical Interbody Fusion System (Genesys Spine - K150812)
LDR Spine Cervical Interbody Fusion System (LDR Spine - K091088) | |
4
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine 3DP Cervical Interbody System includes 3D-Printed (3DP) titanium interbodies. The 3DP Cervical Interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The version that utilizes integrated fixation may be used as a stand-alone cervical device that is implanted with two (2) titanium alloy anchors. All interbodies are made from Ti-6Al-4V ELI titanium alloy. The standalone version includes an integrated locking mechanism and various sizes of anchors which are all manufactured from Ti-6Al-4V ELI titanium alloy.
The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g. anterior plate, posterior cervical screws) may be needed.
INDICATIONS FOR USE
When used with the integrated fixation and as a stand-alone system:
The Genesys Spine 3DP Cervical Interbody Fusion System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Genesys Spine 3DP Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an anterior approach.
When used without the integrated fixation:
The Genesys Spine 3DP Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
TECHNICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Genesys Spine 3DP Cervical Interbody System was compared to the predicate systems and the designs, materials, features, functions, and intended uses were found to be substantially the same.
5
NON-CLINICAL PERFORMANCE EVALUATION
Performance evaluations were conducted on constructs representing the worst-case components (including static compression, static torsion, static compression shear, dynamic compression, dynamic torsion, dynamic compression shear [in accordance with ASTM F2077], subsidence [in accordance with ASTM F2267], expulsion testing, and cadaver testing. The system was also tested to determine the force to overcome the locking mechanism under worst-case conditions. The Genesys Spine 3DP Cervical Interbody System was found to be substantially the same as predicate devices.
CONCLUSION OF NON-CLINICAL TESTS:
The overall technological characteristics and mechanical performance data demonstrate that the Genesys Spine 3DP Cervical Interbody System is substantially equivalent to the Genesys Spine AIS-C Anchored Cervical Stand-Alone System (K181295), the EIT Cellular Titanium® Cervical Cages (K170503), the Genesys Spine Apache® Cervical Interbody Fusion System (K150812), and the Genesys Spine Apache® IBFD System (K103034).