(56 days)
Not Found
No
The summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is specifically indicated for intervertebral body fusion of the lumbar spine to treat degenerative disc disease, which is a therapeutic intervention.
No
Explanation: The device is an intervertebral body fusion device used for treatment (fusion of the lumbar spine), not for diagnosing a condition. Its indication for use explicitly defines it as a treatment for degenerative disc disease.
No
The device description explicitly states it is comprised of "additively manufactured lumbar intervertebral body fusion devices" made from "titanium Ti-6AL-4V ELI alloy," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as an additively manufactured lumbar intervertebral body fusion device made of titanium. This is a physical implant, not a diagnostic tool.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device's purpose is therapeutic (to facilitate fusion).
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral body fusion devices. Numerous styles, footprints, and sizes of interbodies are offered including PLIFs, TLIFs, ALIFs, and LLIFs. The 3DP Lumbar Interbody System implants are manufactured from titanium Ti-6AL-4V ELI alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to 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)
Not Required. Engineering analyses were performed on the Subject Devices and it was determined that a new worst-case was not created, therefore additional testing was not required. The instrument additions mimic previously cleared instruments with minor alterations.
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.
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.
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March 9, 2022
Genesys Spine Chloe Lance Ouality Assurance Engineer 1250 South Capital of Texas Highway, Building 3 Suite 600 Austin, Texas 78746
Re: K220096
Trade/Device Name: Genesys Spine 3DP Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 25, 2022 Received: February 28, 2022
Dear Ms. Lance:
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
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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,
for
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
Enclosure
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Indications for Use
510(k) Number (if known) K220096
Device Name
Genesys Spine 3DP Lumbar Interbody System
Indications for Use (Describe)
The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.
| 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/1 description: The image contains the logo for Genesys Spine. The logo is composed of the word "Genesys" in a sans-serif font, with a stylized "G" that resembles a series of concentric arcs. Below "Genesys" is the word "spine" in a smaller, also sans-serif font, with a registered trademark symbol next to it. The logo is presented in a grayscale color scheme.
| Submitter's Name: | Genesys Spine | |
|---|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway South | |
| Building Three, Suite 600 | ||
| Austin, Texas 78746 | ||
| Contact Name: | Chloe Lance | |
| (Primary) | William W. Sowers | |
| (Secondary) | ||
| Submitter's Telephone: | 512-381-7089 | 512-381-7080 |
| Submitter's Fax: | 512-381-7076 | 512-381-7076 |
| Date Summary was | ||
| Prepared: | January 10, 2022 | |
| Trade or Proprietary | ||
| Name: | Genesys Spine 3DP Lumbar Interbody System | |
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Lumbar | |
| Classification Name: | Intervertebral Body Fusion Device | |
| Classification: | Class II | |
| Regulation Number: | 21 CFR 888.3080 | |
| Product Codes: | MAX | |
| Classification Panel: | Orthopedic Devices Panel | |
| Legally Marketed | ||
| (unmodified) devices to | ||
| Which Substantial | ||
| Equivalence is Claimed: | Predicate: | |
| 3DP Lumbar Interbody System (Genesys Spine – K182987) |
510(K) SUMMARY 4.
Purpose of the 510(k)
The intent of this Special 510(k) is to:
-
- Expand the offering of 3DP PLIFs to the 3DP Lumbar Interbody System
-
- Add system instrumentation
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine 3DP Lumbar Interbody System is comprised of additively manufactured lumbar intervertebral body fusion devices. Numerous styles, footprints, and sizes of interbodies are offered including PLIFs, TLIFs, ALIFs, and LLIFs. The 3DP Lumbar Interbody System implants are manufactured from titanium Ti-6AL-4V ELI alloy.
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INDICATIONS FOR USE
The Genesys Spine 3DP Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is designed for use with supplemental fixation and with autograft to facilitate fusion.
TECHNOLOGICAL COMPARISON TO PREDICATE
The Genesys Spine 3DP Lumbar Interbody System Line Extension was compared to the predicate system and the designs, materials, features, functions, and intended uses were found to be substantially the same.
PERFORMANCE DATA
Not Required. Engineering analyses were performed on the Subject Devices and it was determined that a new worst-case was not created, therefore additional testing was not required. The instrument additions mimic previously cleared instruments with minor alterations.
CONCLUSION
The technology and characteristics of the 3DP Lumbar Interbody System remains unchanged. Finite Element Analysis (FEA) surface area analyses, graft space evaluations, and risk assessments were performed and lead to the conclusion that the 3DP Lumbar Interbody Line Extension additions are substantially equivalent to the Genesys Spine 3DP Lumbar Interbody System (Genesys Spine -K182987).