(290 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found". The devices described are physical clamps and mounts used in conjunction with computer-assisted surgery systems, but the devices themselves do not contain AI.
No
These devices are described as rigid fixation devices for surgical navigation, providing attachment between the patient and a reference frame, rather than directly treating a medical condition or disease.
No
These devices are described as spine referencing devices and shank mounts that provide rigid fixation and attachment to a patient for the duration of surgery when used with computer-assisted surgery systems. Their function is to facilitate stereotactic surgery or aid in navigation, not to diagnose a medical condition.
No
The device is described as "Stealth™ Spine Clamps" and "ModuLeX™ Shank Mounts" which are clearly physical hardware devices intended for rigid fixation and attachment to the patient and reference frame during surgery. The description of performance studies also lists mechanical robustness, functional verification, and biocompatibility, which are all characteristics of hardware devices, not software. The input imaging modality and anatomical site also point to a system that interacts with the physical body, not just software.
No.
The device descriptions and intended uses clearly indicate that these are surgical instruments designed for rigid fixation during spine surgery, used in conjunction with computer-assisted surgery systems. They are not used to perform tests on specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
Stealth™ Spine Clamps
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
- The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
- The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- The Stealth™ spine clamps are indicated for skeletally mature patients.
ModuLeX™ Shank Mounts
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
- The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
- The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
- The ModuLeX™ shank mounts are indicated for skeletally mature patients.
Product codes
OLO
Device Description
The Stealth™ Spine Clamps are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.
The ModuLeX™ Shank Mounts are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.
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 of the anatomy.
Anatomical Site
Vertebra, Spine
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)
Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows:
- Mechanical Robustness and Navigation Accuracy
- Functional Verification
- Useful Life Testing
- Packaging Verification
- Design Validation
- Summative Usability
- Biocompatibility
Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1 and the FDA Guidance Document on Use of ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", indicates that the subject devices are non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic and pose a negligible risk of adverse biological effects to patients when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 - K242464
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 5, 2025
Medtronic Navigation, Inc.
Victoria Baldock
Senior Regulatory Affairs Specialist
200 Medtronic Drive
Lafayette, Colorado 80026
Re: K242464
Trade/Device Name: Stealth™ Spine Clamps; ModuLeX™ Shank Mounts
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: June 2, 2025
Received: June 2, 2025
Dear Victoria Baldock:
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.
Page 2
K242464 - Victoria Baldock Page 2
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).
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-
Page 3
K242464 - Victoria Baldock Page 3
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).
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
FORM FDA 3881 (6/20) Page 1 of 1
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): K242464
Device Name:
Stealth™ Spine Clamps
ModuLeX™ Shank Mounts
Indications for Use (Describe)
Stealth™ Spine Clamps
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
- The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
- The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- The Stealth™ spine clamps are indicated for skeletally mature patients.
ModuLeX™ Shank Mounts
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
- The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
- The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
- The ModuLeX™ shank mounts are indicated for skeletally mature patients.
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
August 19, 2024
I. Company:
Medtronic Navigation, Inc.
200 Medtronic Drive
Lafayette, CO 80026
Telephone Number: (720) 890-3160
Contact: Victoria Baldock
Senior Regulatory Affairs Specialist
Telephone Number: (423) 863-5907
Email: tori.a.baldock@medtronic.com
Kyle Hoefling (Alternate)
Regulatory Affairs Director
Telephone Number: (760) 207-2432
Email: kyle.d.hoefling@medtronic.com
II. Proprietary Trade Name:
Stealth™ Spine Clamps
ModuLeX™ Shank Mounts
III. Common Name:
Orthopedic Stereotaxic Instrument
IV. Classification Name:
Stereotaxic Instrument (21 CFR 882.4560)
V. Classification:
Class II
VI. Product Code:
OLO (Stereotaxic Instrument)
VII. Predicate Devices:
The legally marketed predicate devices are identified below:
| Subject Device | Predicate Device |
|---|---|
| Stealth™ Spine Clamps | StealthStation™ Spinous Process Clamps K211442 S.E. July 8, 2021 |
| ModuLeX™ Shank Mounts | Rod Clamps cleared as an accessory to the Navigated CAPSTONE® Trials, CLYDESDALE® Trials, and CAPSTONE® & CLYDESDALE® Inserter K131425 S.E. August 14, 2013 |
K242464 - Page 1 of 4
Page 6
VIII. Product Description:
The Stealth™ Spine Clamps are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.
The ModuLeX™ Shank Mounts are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.
IX. Indications for Use:
Stealth™ Spine Clamps
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
- The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
- The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- The Stealth™ spine clamps are indicated for skeletally mature patients.
ModuLeX™ Shank Mounts
When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:
- The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
- The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
- The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
- The ModuLeX™ shank mounts are indicated for skeletally mature patients.
X. Comparison of the Technological Characteristics:
Stealth™ Spine Clamps
The subject Stealth™ Spine Clamps utilize the same fundamental scientific technology and have the same mode of operation and functionality as the predicate StealthStation™ Spinous Process Clamps (K211442). The subject devices have equivalent intended use and sterilization/reprocessing methods as the predicate. The changes in indications, configurations,
K242464 - Page 2 of 4
Page 7
and materials from the predicate do not raise any new risks, or any concerns about safety and effectiveness.
Table 1. Technological Comparison of Subject Stealth™ Spine Clamps and Predicate StealthStation™ Spinous Process Clamps
| Technological Characteristic | Stealth™ Spine Clamps (Subject) | StealthStation™ Spinous Process Clamps (Predicate, K211442) |
|---|---|---|
| Intended Use/Indications for Use | When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable: | |
| • The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. | ||
| • The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. | ||
| • The Stealth™ spine clamps are indicated for skeletally mature patients. | The navigated instruments are specifically designed for use with the StealthStation™ System, which is 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 skull, long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. |
When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. |
| Sterilization Method | Non-sterile, Steam sterilization, Reusable | Non-sterile, Steam sterilization, Reusable |
| Patient Fixation | Clamped to spinous process(es) | Clamped to spinous process(es) |
| Configurations | Straight – Short, Medium, Tall
Double – Medium
Angled – Short, Medium | Straight – Short, Medium, Tall
Double – Short, Tall |
| Materials | • Titanium 6Al-4V
• Titanium 6Al-4V with Type II Anondize
• 300 Series Stainless Steel (SS)
• 465 SS with Chrome Coat
• Nitronic 60 with Chrome Coat | • Titanium 6Al-4V
• 300 Series Stainless Steel (SS)
• 17-4 SS with Chrome Coat |
ModuLeX™ Shank Mounts
The subject ModuLeX™ Shank Mounts utilize the same fundamental scientific technology and have similar functionality as the predicate Rod Clamps (K131425). The subject devices have equivalent and sterilization/reprocessing methods as the predicate (K131425). The changes in indications, design, and materials from the predicate do not raise any new risks, or any concerns about safety and effectiveness.
Table 2. Technological Comparison of Subject ModuLeX™ Shank Mounts and Predicate Rod Clamps
| Technological Characteristic | ModuLeX™ Shank Mounts (Subject) | Rod Clamps (Predicate, K131425) |
|---|---|---|
| Indications for Use | When used with Medtronic computer assisted surgery systems, defined as including the | The spine referencing fixation devices are intended to provide rigid attachment |
K242464 - Page 3 of 4
Page 8
| | Stealth™ System, the following indications of use are applicable:
• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
• The ModuLeX™ shank mounts are indicated for skeletally mature patients. | between patient and patient reference frame for the duration of the surgery when used with a Medtronic computer-assisted surgery system. A Medtronic computer-assisted surgery system is defined as including StealthStation™ and/or Mazor™ systems. The devices are intended to be reusable.
The navigated instruments are specifically designed for use with all Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. |
|---|---|---|
| Sterilization Method | Non-sterile, Steam sterilization, Reusable | Non-sterile, Steam sterilization, Reusable |
| Patient Fixation | Attached to the CD Horizon™ ModuLeX™ implanted screw and stabilization pin driven into the patient's body anatomy | Attached to and implanted rod (not implant specific) |
| Materials | • Titanium 6Al-4V
• 465 Stainless Steel (SS)
• 465 SS Chrome Coat
• 300 Series SS | • Titanium 6Al-4V
• 17-4 Stainless Steel |
XI. Discussion of the Performance Testing:
Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows:
- Mechanical Robustness and Navigation Accuracy
- Functional Verification
- Useful Life Testing
- Packaging Verification
- Design Validation
- Summative Usability
- Biocompatibility
Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1 and the FDA Guidance Document on Use of ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", indicates that the subject devices are non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic and pose a negligible risk of adverse biological effects to patients when used as intended.
XII. Conclusion:
The subject Stealth™ Spine Clamps and ModuLeX™ Shank Mounts have shown through comparison to be substantially equivalent to the identified predicate.
K242464 - Page 4 of 4