(56 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 described as a "posterior, non-pedicle supplemental fixation device" intended for use in the spine to achieve "supplemental fusion" for conditions like degenerative disc disease, spondylolisthesis, trauma, tumor, and lumbar spinal stenosis, which are all medical conditions that the device aims to treat or alleviate.
No
Explanation: The device is described as a "posterior, non-pedicle supplemental fixation device" and a "bilateral locking plate system intended for fixation to the spinous process for the purpose of achieving supplemental fusion." Its indications for use are for conditions like degenerative disc disease, spondylolisthesis, trauma, tumor, and/or lumbar spinal stenosis, all of which describe pathological states that the device is intended to treat, not diagnose. There is no mention of the device being used to identify, detect, or monitor a medical condition.
No
The device description clearly states it is a "bilateral locking plate system" consisting of "longitudinal member/anchor components" and an "interconnection component," indicating it is a physical implantable device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The primaLOK™ SP Interspinous Fusion System is a physical implantable device (a plate system) intended for surgical fixation to the spinous process in the spine.
- Intended Use: Its purpose is to provide supplemental fixation for achieving spinal fusion, not to analyze biological samples.
The provided information clearly describes a surgical implant, not a device used for testing biological specimens.
N/A
Intended Use / Indications for Use
The primaLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The primaLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.
Product codes
PEK
Device Description
The primaLOK™ SP Interspinous Fusion System is a bilateral locking plate system intended for fixation to the spinous process for the purpose of achieving supplemental fusion. It is available in various interspinous heights and can accommodate a variety of spinous process widths. The device, as a system, consists of longitudinal member/anchor components (base and polyaxial locking plates) and an interconnection component (connecting post).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1)
Indicated Patient Age Range
Not Found
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
A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence of the primaLOK™ SP System to the predicate devices cited within this Traditional 510(k).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
August 15, 2023
Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wenzel Spine, Inc. % Justin Eggleton Vice President, Head of Musculoskeletal Regulatory Affairs Mcra LLC 803 7th Street NW, Third Floor Washington, District of Columbia 20001
Re: K231807
Trade/Device Name: primaLOK™ SP Interspinous Fusion System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: June 20, 2023 Received: June 20, 2023
Dear Justin Eggleton:
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 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,
Colin O'neill -S
Colin O'Neill, M.B.E. 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
Indications for Use
510(k) Number (if known) K231807
Device Name primaLOKTM SP Interspinous Fusion System
Indications for Use (Describe)
The primaLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The primaLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.
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
510(k) Summary
| Device Trade Name: | primaLOK™ SP Interspinous Fusion System |
|---|---|
| Manufacturer: | Wenzel Spine, Inc. |
| 1130 Rutherford Ln #200 | |
| Austin, TX 78753 | |
| Contact: | William Wilson |
| Chief Executive Officer (CEO) | |
| Wenzel Spine, Inc. | |
| 1130 Rutherford Lane, Suite 200 | |
| Austin, TX 78753 | |
| wwilson@wenzelspine.com | |
| Prepared by: | Justin Eggleton |
| Vice President, Head of Musculoskeletal Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| jeggleton@wenzelspine.com | |
| Office: 202.552.5800 | |
| Secondary | |
| Correspondent: | Michael Coladonato |
| Manager, Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street, NW | |
| Washington, DC 20001 | |
| mcoladonato@mcra.com | |
| Office: 202.552.5800 | |
| Date Prepared: | August 9, 2023 |
| Classifications: | 21 CFR §888.3050 |
| Class: | II |
| Product Codes: | PEK |
| Primary Predicate: | K213266, LESpine Innovations, Inspan® ScrewLES® Fusion |
| Additional Predicate: | K100354, Wenzel Spine Inc., primaLOK™ SP Interspinous Fusion |
| System |
4
The purpose of this Traditional 510(k) is to expand the Indications for Use to include lumbar spinal stenosis for the primaLOK™ SP Interspinous Fusion System, for commercial distribution within the United States of America.
Indications For Use:
The primaLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), tumor, and/or lumbar spinal stenosis. The primaLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.
Device Description:
The primaLOK™ SP Interspinous Fusion System is a bilateral locking plate system intended for fixation to the spinous process for the purpose of achieving supplemental fusion. It is available in various interspinous heights and can accommodate a variety of spinous process widths. The device, as a system, consists of longitudinal member/anchor components (base and polyaxial locking plates) and an interconnection component (connecting post).
Predicate Device:
Wenzel Spine Inc, submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, primaLOK™ SP Interspinous Fusion System is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to predicate devices:
Primary Predicate: Inspan ScrewLES Fusion System, LESpine Innovations (K213266)
Additional Predicate: primaLOK™ SP Interspinous Fusion, Wenzel Spine, Inc. (K100354)
Performance Testing Summary:
A variety of clinical data and biomechanical evaluations have been conducted in order to support the substantial equivalence of the primaLOK™ SP System to the predicate devices cited within this Traditional 510(k).
Substantial Equivalence:
It has been determined that the primaLOK™ SP System is substantially equivalent to the predicate devices based upon indications, intended use, technological characteristics, principles of operation, materials, biocompatibility, sterility, shelf-life, and packaging.
Conclusion:
The primaLOK™ SP System is substantially equivalent to the cited predicate devices.