SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

K260571 · Life Spine, Inc. · OLO · Jun 2, 2026 · Neurology

Device Facts

• Record ID: K260571
• Device Name: SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
• Applicant: Life Spine, Inc.
• Product Code: OLO · Neurology
• Decision Date: Jun 2, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Indications for Use

The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are intended to be used during the preparation and placement of the SIMPACT Sacroiliac Joint Fixation System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S7 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 the pelvis or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy

Device Story

Reusable stainless steel surgical instruments (screwdrivers, drills, taps, pin guides) designed for use with Medtronic StealthStation S7 navigation system; instruments facilitate precise anatomical localization during spinal surgery; surgeon uses instruments in conjunction with navigation system to track position relative to patient anatomy (pelvis/vertebra) via CT/MR models or fluoroscopy; assists in preparation and placement of SIMPACT Sacroiliac Joint Fixation System; intended for open or minimally invasive procedures; provides visual guidance to surgeon for improved placement accuracy.

Clinical Evidence

No clinical data. Bench testing only, including design validation, dimensional comparison, and tolerance analysis to ensure functionality and compatibility with the Medtronic StealthStation S7 system.

Technological Characteristics

Reusable surgical instruments manufactured from Stainless Steel (ASTM F899). System includes screwdrivers, drills, taps, and pin guides. Designed for integration with Medtronic StealthStation S7 navigation system. Non-sterile.

Indications for Use

Indicated for adult patients undergoing spinal surgery requiring preparation and placement of the SIMPACT Sacroiliac Joint Fixation System; assists surgeons in locating anatomical structures during open or minimally invasive procedures using stereotactic navigation.

Regulatory Classification

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.

Predicate Devices

• Orthofix Firebird SI Navigation System (K252088)
• Medtronic Rialto Navigation (K251395)
• Medtronic Rialto Navigation (K161210)
• Life Spine GX Navigation Instruments (K202836)
• Life Spine Simpact Sacroiliac Joint Fixation System (K212903)
• Life Spine Simpact Sacroiliac Joint Fixation System (K201538)
• Life Spine Simpact Sacroiliac Joint Fixation System (K180749)
• Life Spine Simpact Sacroiliac Joint Fixation System (K141246)

Submission Summary (Full Text)

{0}

**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION

June 2, 2026

Life Spine, Inc.
Angela Batker
Director of RA/QA & Corporate Compliance Officer
13951 Quality Dr.
Huntley, Illinois 60142

Re: K260571

Trade/Device Name: SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

Regulation Number: 21 CFR 882.4560

Regulation Name: Stereotaxic Instrument

Regulatory Class: Class II

Product Code: OLO

Dated: May 4, 2026

Received: May 4, 2026

Dear Angela Batker:

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'

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
www.fda.gov

{1}

K260571 - Angela Batker

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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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 ([e-mail]) or phone [phone] or 301-796-7100).

{2}

K260571 - Angela Batker

Page 3

Sincerely,

**STEPHANIE SMITH -S**

For 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

{3}

# Indications for Use

| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K260571 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | | | |
| Please provide your Indications for Use below. | | | ? |
| The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are intended to be used during the preparation and placement of the SIMPACT Sacroiliac Joint Fixation System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S7 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 the pelvis or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |

{4}

K260571
Page 1 of 2

# **510(k) Summary**
**Life Spine SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments**

**Submitted By:**
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: [phone]
Fax: [phone]

**510(k) Contact:**
Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: [phone]
Fax: [phone]

**Date Prepared:**
April 20th, 2026

**Trade Name:**
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

**Common Name:**
Sacroiliac Joint Fixation

**Classification:**
OLO, CFR 882.4560, Class II

**Primary Predicate:**
Orthofix Firebird SI Navigation System K252088

**Additional Predicates:**
Medtronic Rialto Navigation K251395 & K161210
Life Spine GX Navigation Instruments K202836
Life Spine Simpact Sacroiliac Joint Fixation System K212903, K201538,
K180749 & K141246

# **Device Description:**

The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are manufactured from Stainless Steel as specified in ASTM F899, non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® S7 System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use.

The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are for use with systems, specifically:

- Screwdriver
- Non-Cannulated Drills
- Cannulated Drills
- Non-Cannulated Taps
- Cannulated Taps
- Steinmann Pin Guide

{5}

K260571
Page 2 of 2

### **Indications for Use:**

The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments are intended to be used during the preparation and placement of the SIMPACT Sacroiliac Joint Fixation System during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation® S7 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 the pelvis or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

### **Material:**

This submission seeks clearance of a device made from Stainless Steel (SS) described by ASTM F899. This is the same material used in the predicate devices.

### **Non-Clinical Testing:**

Design validation, including dimensional comparison and tolerance analysis, was performed to ensure the Simpact Sacroiliac Joint Fixation System GX Navigation Instruments are acceptable for its intended use, to ensure functionality and compatibility with the Medtronic® StealthStation® S7 System using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instrument systems.

### **Substantial Equivalence:**

The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

### **Conclusion:**

The information presented demonstrates the substantial equivalency of The SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments.