(268 days)
The Karma® Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.
The Karma® Fixation System is a system that provides adjunctive fixation. The system consists of a PEEK band. The Karma band consists of a strap manufactured from PEEK compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip of the device contains a tantalum insert for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taut by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the bony structures. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded. An instrument, Tensioner, is provided and can be used fully tension the implant.
The provided FDA 510(k) clearance letter and summary for the Karma® Fixation System is for a medical device (spinal fixation system), not a software device or AI-powered system that would typically have acceptance criteria focused on algorithm performance metrics like sensitivity, specificity, or AUC. Therefore, the questions related to AI performance, such as sample size for test sets, expert adjudication, MRMC studies, standalone performance, and training set details, are not applicable to this submission.
The "acceptance criteria" for a medical device like the Karma® Fixation System are typically related to:
- Mechanical and Biomechanical Performance: Ensuring the device can withstand expected physiological loads and perform its intended structural function.
- Biocompatibility: Verifying that the materials used are safe for implantation in the human body.
- Sterilization: Confirming the device can be effectively sterilized.
- Labeling and Packaging: Ensuring proper information is provided.
- Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.
The study that proves the device meets its acceptance criteria (i.e., its safety and effectiveness compared to a predicate) is discussed under "Performance Data" and "Clinical Data."
Here's an interpretation based on the information provided, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a spinal fixation system, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to a predicate device in terms of safety and effectiveness. The "reported device performance" refers to the studies conducted to support this equivalence. Specific numerical acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) are often part of the detailed testing protocols submitted to the FDA but are not explicitly listed in this summary.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Biomechanical Stability | Demonstrated through biomechanical cadaveric testing. |
| Durability/Fatigue Life | Demonstrated through Finite Element Analysis (FEA). |
| Material Compatibility/Wear | Demonstrated through cadaveric abrasion testing. |
| Functional Equivalence | Usability studies conducted to evaluate operating principle. |
| Clinical Safety and Effectiveness | Evaluated using CT evaluations at 12 and 24 months, adverse event data, and patient-reported outcomes (ODI, VAS for back/leg pain). |
| Design, Material, Manufacturing Equivalence | Claimed to be identical to the reference device (K180728 / K190289). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Biomechanical studies: Not specified, but typically involves a small number of cadaveric spines.
- Clinical Data: Not specified, but includes CT evaluations, adverse event data, and patient-reported outcomes at 12 and 24 months. The specific number of patients is not mentioned.
- Data Provenance: Not explicitly stated (e.g., country of origin). The nature of the clinical data (CT evaluations, adverse events, patient-reported outcomes at specific follow-up points) suggests a prospective or retrospective clinical study, but this is not definitively stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of device submission. The "ground truth" for a spinal fixation system is typically established through objective measurements in mechanical/biomechanical testing and clinical outcomes, rather than expert consensus on image interpretation. Clinical assessments would be performed by qualified medical professionals (e.g., surgeons, radiologists), but their specific number or qualifications for "ground truth establishment" are not relevant in the context of AI model evaluation.
4. Adjudication Method for the Test Set
This question is not applicable as it pertains to expert disagreement resolution in AI model evaluation, which is not relevant for musculoskeletal implants.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. MRMC studies are specific to evaluating AI-assisted diagnostic or interpretative devices, not spinal fixation systems.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Karma® Fixation System is a physical implant, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance assessment relies on a combination of:
- Biomechanical Data: Objective measurements from cadaveric testing (e.g., stability, stiffness).
- Computational Modeling: Results from Finite Element Analysis (FEA) predicting stress distribution and fatigue.
- Clinical Outcomes Data:
- Imaging: CT evaluations at 12 and 24 months.
- Adverse Event Data: Reported complications.
- Patient-Reported Outcomes (PROs): Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain.
8. The Sample Size for the Training Set
This question is not applicable. The Karma® Fixation System is a physical medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no "training set" for this type of device.
FDA 510(k) Clearance Letter - Karma® Fixation System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 21, 2025
Spinal Elements, Inc.
Cheryl Allen
Associate Director, Regulatory Affairs
3115 S. Melrose Suite 200
Carlsbad, California 92010
Re: K242527
Trade/Device Name: The Karma® Fixation System
Regulatory Class: Unclassified
Product Code: MRW
Dated: April 23, 2025
Received: April 23, 2025
Dear Cheryl Allen:
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).
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K242527 - Cheryl Allen
Page 2
Your device is also subject to, among other requirements, the Quality System (QS) 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K242527 - Cheryl Allen
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Sincerely,
Maziar Shah Mohammadi
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
Page 4
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K242527
Device Name: Karma® Fixation System
Indications for Use (Describe)
The Karma Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.
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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Page 5
510(k) Summary
Karma® Fixation System
Date: May 13, 2025
I. SUBMITTER
Company Information:
Spinal Elements, Inc.
3115 Melrose Dr., Suite 200
Carlsbad, CA 92010
Contact Information:
Cheryl Allen
Associate Director,
760-607-1840
callen@spinalelements.com
II. DEVICE
Proprietary Name: Karma® Fixation System
Common Name: Facet Fixation System
Device Classification: unclassified
Proposed Regulatory Class: unclassified
Device Product Code: MRW
Primary Predicate Device: zLOCK Lumbar Facet Fixation System (K240085)
Reference Device: Karma Fixation System (K180728 / K190289)
III. DEVICE DESCRIPTION
The Karma® Fixation System is a system that provides adjunctive fixation. The system consists of a PEEK band. The Karma band consists of a strap manufactured from PEEK compounded with 7.5% barium sulphate for radiopacity. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap around the bony structures to be secured. The spherical tip of the device contains a tantalum insert for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taut by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the bony structures. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded. An instrument, Tensioner, is provided and can be used fully tension the implant.
IV. INDICATION FOR USE
The Karma Fixation System is intended for bilateral facet stabilization for fusion as an adjunct to a 1-level interbody lumbar fusion from L1 to L5 with autogenous and/or allogenic bone graft. The Karma Fixation System must be accompanied by an FDA cleared intervertebral body fusion device implanted at the same spinal level. The Karma Fixation System is indicated for the treatment of patients with lumbar degenerative disc disease at a single level from L1 to L5 in skeletally mature patients who have failed conservative care.
K242527- Page 1 of 2
Page 6
VII. TECHNOLOGICAL CHARACTERISTICS OF DEVICE
Karma Fixation System is identical to the reference device regarding device design, device description, technological characteristics (design, components, material, chemical composition, manufacturing, labeling, sterility, etc). The Karma Fixation System has similar indications to the primary predicate.
VIII. PERFORMANCE DATA
The subject device has the same performance characteristics as the previously cleared reference devices. Usability studies were conducted to evaluate the Karma Fixation System operating principle. Biomechanical cadaveric, Finite Element Analysis, cadaveric abrasion testing were also performed.
IX. CLINICAL DATA
Clinical performance data for intra-laminar placement was evaluated using CT evaluations at 12 and 24 months, adverse event data, and patient reported outcomes (Oswestry Disability Index and visual analog scale for back and leg pain).
X. SUBSTANTIAL EQUIVALENCE
Karma Fixation System has been found to be substantially equivalent to the predicate device with respect to intended use/indications for use, device description, technological characteristics and performance.
K242527- Page 2 of 2
N/A