Genesys Spine 3DP AIS-C II Cervical Interbody System

K233594 · Genesys Spine · OVE · Dec 13, 2023 · Orthopedic

Device Facts

Record IDK233594
Device NameGenesys Spine 3DP AIS-C II Cervical Interbody System
ApplicantGenesys Spine
Product CodeOVE · Orthopedic
Decision DateDec 13, 2023
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3080
Device ClassClass 2
AttributesTherapeutic

Intended Use

When used with the integrated fixation and as a stand-alone system: The Genesys Spine 3D Printed AIS-C II 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 3D Printed AIS-C II 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 3D Printed AIS-C II 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 discogenc 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.

Device Story

3D-printed titanium interbody fusion system for anterior cervical spine; used as stand-alone with integrated fixation anchors or with supplemental plating. Device inputs: autogenous bone graft (placed in interbody). Operation: interbody inserted into disc space; integrated titanium anchors deployed into vertebral bodies; cam lock mechanism (titanium alloy with PEEK washer) rotated counterclockwise to secure anchors and prevent back-out. Used in clinical/surgical settings by surgeons. Output: stabilized intervertebral space to facilitate fusion. Benefits: provides structural support and stability for spinal fusion; improved anchor push-out strength and tactile feedback compared to predicate; accommodates varied patient anatomy via 10-degree lordotic option.

Clinical Evidence

Bench testing only. Performance evaluated via static torsion, static compression shear, dynamic compression, dynamic torsion, and dynamic compression shear per ASTM F2077. Anchor push-out testing demonstrated superior results to predicates. Finite Element Analysis (FEA) confirmed mechanical stresses for the 10-degree lordotic interbody are within safe limits. Biocompatibility and sterilization/cleaning analyses performed for titanium and PEEK components.

Technological Characteristics

Materials: Ti-6Al-4V ELI titanium alloy, PEEK washer. Principle: Intervertebral body fusion via anterior approach with integrated cam-locking anchor system. Dimensions: Various sizes including 10-degree lordotic option. Connectivity: None. Sterilization: Not specified. Mechanical testing: ASTM F2077.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1 with radicular symptoms, confirmed by history and radiography, following six weeks of failed non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{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. December 13, 2023 Genesys Spine Andrew Davison Senior Vice President of Quality and Regulatory 1250 S. Capital of Texas Highway Building 3, Suite 600 Austin. Texas 78746 Re: K233594 Trade/Device Name: Genesys Spine 3DP AIS-C II Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: November 8, 2023 Received: November 8, 2023 Dear Andrew Davison: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Showalter -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K233594 #### Device Name Genesys Spine 3DP AIS-C II Cervical Interbody System #### Indications for Use (Describe) When used with the integrated fixation and as a stand-alone system: The Genesys Spine 3D Printed AIS-C II 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 3D Printed AIS-C II 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 3D Printed AIS-C II 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 discogenc 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) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K233594 Page 1 of 1 #### 510(k) Summary Prepared on: 2023-11-08 21 CFR 807.92(a)(1) ## Contact Details 21 CFR 807.92(a)(1) | Applicant Name | Genesys Spine | |-----------------------------|--------------------------------------------------------------------------------------| | Applicant Address | 1250 S. Capital of Texas Highway Building 3, Suite 600 Austin TX 78746 United States | | Applicant Contact Telephone | 512-431-7255 | | Applicant Contact | Mr. Andrew Davison | | Applicant Contact Email | andrew.davison@genesysspine.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | Genesys Spine 3DP AIS-C II Cervical Interbody System | |---------------------|-----------------------------------------------------------------| | Common Name | Intervertebral body fusion device | | Classification Name | Intervertebral Fusion Device With Integrated Fixation, Cervical | | Regulation Number | 888.3080 | | Product Code | OVE | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |-------------|----------------------------------------------------------|--------------| | K191489 | Genesys Spine 3DP Cervical Interbody System | OVE | Device Description Summary 21 CFR 807.92(a)(4)#### GENERAL OVERVIEW The Genesys Spine 3DP Als-C II Cervical Interbody System includes 3D-Printed (3DP) titanium interbody System offers a stand-alone version as well as a traditional (Regular) interbody that requires supplemental fixation. The interbody that utilizes supplemental fixation may be used as a stand-alone that is implanted with two (2) titanium alloy anchors. This version includes an integrated cam lock mechanism and various The cam lock mechanism may be used as a secondary aid in keeping the anchors from backing out of the interbody and vertebral bodies after anchor deployment. After anchor deployment, in order to engage the cam lock key instrument is used to turn the lock (counterclockwise direction) from an open to closed position. When closed, the wings of the cam lock slide over the anchor channels and provide a backing cover for the anchor and anchor channels. Al interbodies and anchors are made from Ti-6Al-4V ELI titanium alloy. The cam lock is made out Ti-6Al-4V ELI titanium alloy with a PEEK washer. 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 cervical screws) may be needed. #### PRODUCT SPECIFICATIONS AND DIMENSIONS Product and engineering specifications, and engineering drawings or all implants and system specific instruments are provided as attached. {4}------------------------------------------------ #### SURGICAL TECHNIQUE A detailed surgical technique is available as attached. The surgical technique for implants, anatomical location of use, various user interfaces how the device interacts with other device interacts with the patient. ### Intended Use/Indications for Use When used with the integrated fixation and as a stand-alone system: The Genesys Spine 3D Printed AIS-C II 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 3D Printed AlS-C II 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 3D Printed AlS-C II Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with deceneration of the disc confirmed by history and radios; 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. # Indications for Use Comparison The Indications for Use remain the same. ### Technological Comparison The primary predicate device for this 510(k) is the Genesys Spine 3DP AIS-C Cervical Standalone Interbody Fusion System (K191489). Both systems offer cervical anchored interbody systems with an OVE product classification. A locking mechanism to secure the integrated fixation anchors are used in both systems. The identical to the predicate. The principles of operation are the same. The anchoring technology is identical and testing shows that the subject interbody device is as effective as the primary predicate device. The footprints, sizes, and overall geometry are the same. In addition, non-clinical performance (bench) testing shows the 3DP AlS-C II Cervical Interbody Fusion System has the equivalent or better capabilities compared to the primary predicate system or market competitors. The subject devices differ from the primary predicate Genesys Spine Interbody System in the following characteristics: - Locking Mechanism titanium alloy cam lock with PEEK washer • Interbody Lock Recess Geometry - · Addition of a 10 degree lordosis angle for the Lordotic Interbody • Anchor Geometry In order to clarify the details behind this analysis each of the differences from the primary predicate was evaluated in the following manner: - Locking Mechanism: The locking mechanism used on the 3DP AlS-C II Cervical Interbody Fusion System was modified from a titanium alloy flange lock (predicate) to a titanium alloy with PEEK washer to previous locks used on predicate interbodies the cam lock provides greater Anchor push-out strength and a more intuitive user interface. o Anchor Push-Out testing was conducted, and the results proved superior to predicates. o Biocompatibility analysis was performed for both PEEK and titanium alloy along with the mating feature of the cam lock does not introduce any new worst-case in any criteria and is safe and effective. o Sterilization/Cleaning analysis was performed on the titanium cam lock and PEEK washer. The cam lock does not introduce any new worst-case in any criteria and is deemed safe and effective. o Design Validation testing was performed, and user feedback confirmed superior usability to predicates. - Interbody Lock Recess Geometry: The recess geometry for mating the interbody was modified to allow assembly of the new locking mechanism. ### 21 CFR 807.92(a)(6) 21 CFR 807.92(a)(5) 21 CFR 807.92(a)(5) {5}------------------------------------------------ K233594 Page 1 of 3 o The mechanical performance of the system was evaluated in static torsion, static compression shear, dynamic compression, dynamic torsion, and dynamic compression shear in accordance with ASTM F2077. Test results indicated the revised interbody did not pose additional risks to safety and effectiveness of the devices. · Addition of 10 Degree Lordotic Interbody: In order range of the population and user demographic an explicit 10 degree lordotic interbody was created. o Finite Element Analysis was conducted, and the results proved that the 10 degree lorodic interbody did not introduce any new worstcase in regards to mechanical stresses and standardized testing and was still superior to predicate. o Design Validation testing was performed, and user feedback confirmed superior usability to predicates. · Anchor Geometry: The anchor geometry remains almost identical to what was released under K191489. The mochor was the addition of a small interference ramp up on the side of the anchor. This was done in order to provide perceptual indication that the anchor was secure, but also provide tactile feedback that the anchor was not loose within the interbody channel. o Anchor Push-Out testing was conducted, and the results proved superior to predicates. o Design Validation testing was performed, and user feedback confirmed superior usability to predicates. All interbody devices, which all have the same as previously cleared by the predicate 510(k) submission: K191489. The design of the integrated locking mechanism has been improved to increase anchor push-out forces and physician usbility. The cervical Anchors, which all have the GAC- prefix, have been updated slightly from the previously cleared 510(k) submission K191489. The Genesys Spine 3DP AIS-C II Cervical Interbody Fusion System was compared to the designs, materials, features, functions, intended uses and overall technology were found to be substantially equivalent. As a result of this analysis, the system differences would not impact safety or effectiveness. This analysis can be found in the substantial equivalence comparison attachment. Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) N/A
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%