(85 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is an interbody fusion device intended to treat degenerative disc disease and facilitate fusion in the cervical spine, which is a therapeutic purpose.
No
The device is an interbody device intended for fusion in the cervical spine to treat degenerative disc disease, providing mechanical support. It does not perform diagnostic functions.
No
The device description explicitly details physical implants made from PEEK, tantalum, and titanium, along with screws, intended for surgical implantation. It also describes mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The NexGen Standalone ACDF System is a surgical implant designed to be placed within the body to facilitate fusion in the cervical spine. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory testing.
Therefore, the NexGen Standalone ACDF System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NexGen Standalone ACDF System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The NexGen implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
The NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. NexGen Interbody devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior titanium portion of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
All implantable components are made from medical grade polyetheretherketone (PEEK), tantalum, and titanium or titanium alloy as described by such standards as ASTM F2026, ASTM F560, and ASTM F136/ISO 5832-3. The products are supplied clean and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (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)
The NexGen Standalone ACDF System has been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic compression shear per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- o Subsidence per ASTM F2267
The results of this non-clinical testing show that NexGen Standalone ACDF System is sufficient for its intended use and is 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.
K132029, K173077, K102606, K152793
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
Image /page/0/Picture/0 description: The image shows 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.
January 12, 2021
Precision Spine, Inc. % Nathan Wright, MS Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K203129
Trade/Device Name: NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: October 15, 2020 Received: October 19, 2020
Dear Mr. Wright:
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.
1
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 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 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K203129
Device Name
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System Indications for Use (Describe)
The NexGen Standalone ACDF System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The NexGen implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
| 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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FORM FDA 3881 (7/17)
3
510(K) SUMMARY
| Submitter's Name: | Precision Spine, Inc. |
|---|---|
| Submitter's Address: | 2050 Executive Drive |
| Pearl, MS 39208 | |
| Submitter's Telephone: | 1-601-420-4244 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | October 15, 2020 |
| Trade or Proprietary Name: | NexGen Standalone Anterior Cervical Discectomy and |
| Fusion (ACDF) System | |
| Common or Usual Name: | Intervertebral Fusion Device with Integrated Fixation, |
| Cervical | |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE, ODP |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. NexGen Interbody devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior titanium portion of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
All implantable components are made from medical grade polyetheretherketone (PEEK), tantalum, and titanium or titanium alloy as described by such standards as ASTM F2026, ASTM F560, and ASTM F136/ISO 5832-3. The products are supplied clean and non-sterile.
INDICATIONS FOR USE
The NexGen Standalone ACDF System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The NexGen implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.
Precision Spine, Inc. NexGen Standalone ACDF System
4
TECHNOLOGICAL CHARACTERISTICS
The NexGen Standalone ACDF System is made from PEEK per ASTM F2026, tantalum per ASTM F560, and Ti-6AI-4V ELI per ASTM F136/ISO 5832-3. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture ●
- Structural support mechanism ●
- Sizes and Styles
- . Mechanical Strength
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|--------------------------------------------------------|-----------------------|-------------------|
| K132029 | Vault-C Standalone Cervical
Interbody Fusion System | Spinal USA, Inc. | Primary |
| K173077 | Cavetto®-SA Cervical
System | Neurostructures, Inc. | Additional |
| K102606 | AVS® Anchor-C Cervical
Cage System | Stryker Spine | Additional |
| K152793 | Unison-C Anterior Cervical
Fixation System | RTI Surgical | Additional |
PERFORMANCE DATA
The NexGen Standalone ACDF System has been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic compression shear per ASTM F2077
- Static and dynamic torsion per ASTM F2077
- o Subsidence per ASTM F2267
The results of this non-clinical testing show that NexGen Standalone ACDF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the NexGen Standalone ACDF System is substantially equivalent to the predicate device.