(266 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on reusable surgical instruments used with existing navigation systems, rather than indicating any inherent AI capabilities within the instruments themselves.
No
The device is a reusable surgical instrument system that assists surgeons in placing screws during spinal surgery, which is a tool for a procedure, not a device that provides therapy itself.
No
The device is a surgical instrument (navigation reusable instruments) intended to assist surgeons in precisely locating anatomical structures during spinal surgery when used with navigation systems. It does not perform diagnostic functions, such as identifying or confirming a medical condition or disease.
No
The device is described as a "reusable instrument" and an "adaptor," indicating physical hardware components, not purely software. Its function is to enable the navigation of physical surgical instruments with existing navigation systems.
No.
The device is a surgical instrument used to assist surgeons in precisely locating anatomical structures during spinal surgery, which is an in-vivo application, not an in-vitro diagnostic.
N/A
Intended Use / Indications for Use
The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Product codes
OLO
Device Description
The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks
Anatomical Site
rigid anatomical structure, such as a long bone, or vertebra, spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
The following testing were conducted on the SPINEART Brainlab® Navigation Adaptor (subject device) to establish substantial equivalence with the predicate devices:
- Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device).
- Accuracy in simulated use (protocol adapted from ASTM F2554-22): Verification of the Navigation adaptor with SPINEART Navigation reusable instruments and the full Brainlab® chain of the Brainlab Spine & Trauma system.
- A dimensional analysis further confirmed that adequate navigation accuracy will be maintained with the subject instruments. Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria.
No clinical testing was required for the subject device.
It has been demonstrated that the addition of the SPINEART Brainlab® Navigation Adaptor (subject device) on the SPINEART Navigation reusable instruments (predicate device) for a use with the Brainlab® Spine & Trauma System does not raise accuracy issues.
Key Metrics
accuracy
Predicate Device(s)
K241644, K210472, K183630, K212245, K242890
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - SPINEART Navigation Instrument System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 18, 2025
Spineart SA
Estelle Lefeuvre
Regulatory & Market Access Manager
3 chemin du Pré-Fleuri
Plan Les Ouates, 1228
Switzerland
Re: K242933
Trade/Device Name: SPINEART Navigation Instrument System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: September 25, 2024
Received: September 25, 2024
Dear Estelle Lefeuvre:
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"
Page 2
June 18, 2025
Spineart SA
Estelle Lefeuvre
Regulatory & Market Access Manager
3 chemin du Pré-Fleuri
Plan Les Ouates, 1228
Switzerland
Re: K242933
Trade/Device Name: SPINEART Navigation Instrument System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: September 25, 2024
Received: September 25, 2024
Dear Estelle Lefeuvre:
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"
K242933 - Estelle Lefeuvre Page 2
(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).
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
Page 3
K242933 - Estelle Lefeuvre Page 3
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumaya Ali, M.P.H.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242933
Device Name
SPINEART Navigation Instrument System
Indications for Use (Describe)
The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) Summary
510(k)#: K242933 Prepared on: 2025-06-18
Contact Details 21 CFR 807.92(a)(1)
| Applicant Name | SPINEART SA |
|---|---|
| Applicant Address | 3 chemin du Pré-Fleuri PLAN LES OUATES 1228 Switzerland |
| Applicant Contact Telephone | +41 22 570 1203 |
| Applicant Contact | Ms. ESTELLE LEFEUVRE |
| Applicant Contact Email | elefeuvre@spineart.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | SPINEART Navigation Instrument System |
|---|---|
| Common Name | Orthopedic Naviagated instruments |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code(s) | OLO |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K241644 | SPINEART Navigation Instrument System | OLO |
| K210472 | SPINEART Navigation Instrument System | OLO |
| K183630 | SPINEART Navigation Instrument System | OLO |
| K212245 | Spine and Trauma Navigation System | OLO |
| K242890 | SPINEART Navigation Instrument System | OLO |
Device Description Summary 21 CFR 807.92(a)(4)
The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
Page 6
The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Indications for Use Comparison 21 CFR 807.92(a)(5)
Compared to predicate devices (K241644, K210472, K183630) the only modification to the indications for use is to add the option of using the SPINEART Navigation Reusable Instrument system with the Brainlab® Navigation System through the introduction of a SPINEART Brainlab® Navigation Adaptor. The added SPINEART Brainlab® Navigation Adaptor does not alter the intended use of the SPINEART Navigation Reusable Instrument system.
Technological Comparison 21 CFR 807.92(a)(6)
The intended use, design features, technological characteristics, feature comparisons and performance assessment of the subject SPINEART Navigation Reusable Instrument system remain the same as predicate devices (SPINEART Navigation Reusable Instrument system K241644, K210472, K183630). It has been established that the addition of the SPINEART Brainlab® Tracker Adaptor on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System does not raise accuracy issues, and has very similar design and operation to the adapter cleared in K242890. The added SPINEART Brainlab® Navigation Adaptor does not affect the safety and effectiveness of the device relative to the predicate (SPINEART Navigation Reusable Instrument system K241644, K210472, K183630). Based on the comparison to the predicate devices and the performance testing conducted, the subject device is considered substantially equivalent to the predicate devices (K241644, K210472, K183630).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following testing were conducted on the SPINEART Brainlab® Navigation Adaptor (subject device) to establish substantial equivalence with the predicate devices:
- Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device).
- Accuracy in simulated use (protocol adapted from ASTM F2554-22): Verification of the Navigation adaptor with SPINEART Navigation reusable instruments and the full Brainlab® chain of the Brainlab Spine & Trauma system.
- A dimensional analysis further confirmed that adequate navigation accuracy will be maintained with the subject instruments. Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria.
No clinical testing was required for the subject device.
It has been demonstrated that the addition of the SPINEART Brainlab® Navigation Adaptor (subject device) on the SPINEART Navigation reusable instruments (predicate device) for a use with the Brainlab® Spine & Trauma System does not raise accuracy issues.