Who is the manufacturer of Integrity Implants Navigated Instruments?

Integrity Implants, Inc. filed the 510(k) submission for Integrity Implants Navigated Instruments (K212088).

What is the FDA product code for Integrity Implants Navigated Instruments?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Integrity Implants Navigated Instruments?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Integrity Implants Navigated Instruments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Integrity Implants Navigated Instruments

Q: What are the predicate devices for Integrity Implants Navigated Instruments?

Navigated CD Horizon Solera Screwdriver/Taps (K140454).

K212088 · Integrity Implants, Inc. · OLO · Dec 23, 2021 · Neurology

Device Facts

Record ID	K212088
Device Name	Integrity Implants Navigated Instruments
Applicant	Integrity Implants, Inc.
Product Code	OLO · Neurology
Decision Date	Dec 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's 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 vertebra, can be identified relative to a CT or MR-based model, finages, or digitized landmarks of the anatomy.

Device Story

Integrity Implants Navigated Instruments consist of non-sterile stainless steel and Radel surgical instruments, including screw drivers, cannulated/solid taps, probes, and awls. These instruments are designed to interface with the Medtronic StealthStation System and NavLock Tracker. During spinal surgery, the instruments provide navigation data to the StealthStation, allowing the surgeon to track the instrument tip relative to patient anatomy (CT/MR models or digitized landmarks). The system assists in the precise preparation and placement of spinal implants. Used in OR settings by surgeons; the device provides visual guidance on the StealthStation display, aiding in accurate anatomical targeting and implant positioning. Benefits include improved surgical precision and navigation during spinal procedures.

Clinical Evidence

Bench testing only. Accuracy testing performed per ASTM F2554-18 to verify positional accuracy with the Medtronic StealthStation System and NavLock Tracker. Registration testing confirmed instrument compatibility. Dimensional analysis demonstrated equivalence to predicate. Cleaning and sterilization validation leveraged from K190360.

Technological Characteristics

Materials: Stainless steel and Radel. Components: Cannulated/solid taps (4.0-10.5 mm), probes, awls, screw drivers. Navigation: Compatible with Medtronic StealthStation System and NavLock Tracker. Sterilization: Non-sterile (intended for reprocessing). Accuracy testing: ASTM F2554-18.

Indications for Use

Indicated for use during spinal surgery to assist surgeons in precisely locating anatomical structures for the preparation and placement of Integrity Implants spinal implants in open or minimally invasive procedures. Designed for use with Medtronic StealthStation System in conditions where stereotactic surgery is appropriate and rigid anatomical structures (vertebrae) can be referenced to CT/MR models or digitized landmarks.

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

Navigated CD Horizon Solera Screwdriver/Taps (K140454)

Reference Devices

LineSider® Spinal System (K190360)
LineSider® Spinal System (K203367)

Related Devices

K241082 — INNOVERSE Navigation Instruments · Innosys Co., Ltd. · Jun 14, 2024
K202956 — Erisma LP Navigated Instruments · Clariance, Sas · Feb 26, 2021
K200719 — NuVasive Navigation.S Instruments · Nu Vasive, Incorporated · Dec 2, 2020
K172517 — SeaSpine Navigation System · SeaSpine Orthopedics Corporation · May 11, 2018
K190881 — Spinal Elements Navigated Instruments · Spinal Elements, Inc. · Dec 19, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 23, 2021 Integrity Implants Inc. % Roshana Ahmed Sr. Regulatory Specialist TELOS Partners, LLC 571 Christina Lake Drive Lakeland, Florida 33813 Re: K212088 Trade/Device Name: Integrity Implants Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 22, 2021 Received: November 24, 2021 Dear Roshana Ahmed: 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. {1}------------------------------------------------ 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 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. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212088 ## Device Name Integrity Implants Navigated Instruments ## Indications for Use (Describe) Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's 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 vertebra, can be identified relative to a CT or MR-based model, finages, or digitized landmarks of the anatomy. Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### I. Submitter Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens, FL 33418 Phone: 561-529-3861 Contact Person: Roshana Ahmed, M.A., RAC, Senior Regulatory Specialist, Telos Partners LLC Secondary Contact Person: Lauren Kamer, Sr. Director of Reg Affairs, Integrity Implants Inc. Date Prepared: December 22, 2021 #### II. Device | Device Proprietary Name: | Integrity Implants Navigated Instruments | |--------------------------|------------------------------------------| | Common or Usual Name: | Navigation Instruments | | Classification Name: | Stereotaxic Instruments | | Regulation Number: | 21 CFR 882.4560 | | Product Code: | OLO | | Device Classification: | II | #### III. Predicate Device Substantial equivalence is claimed to the following primary predicate devices: - Navigated CD Horizon Solera Screwdriver/Taps, K140454, Medtronic Sofamor Danek ● USA, Inc. The following secondary predicate devices are cited within the submission: - LineSider® Spinal System, K190360, Integrity Implants, Inc. ● - LineSider® Spinal System, K203367, Integrity Implants, Inc. ● #### IV. Device Description The Integrity Implants Navigated Instruments include non-sterile screw drivers, cannulated and solid taps (4.0 - 10.5 mm), probes, and awls designed to function with the Medtronic StealthStation® System and NavLock® Tracker. The subject devices are for use with the Integrity Implants LineSider® Spinal System (K190360 and K203367). The instruments are manufactured from stainless steel and Radel. {4}------------------------------------------------ #### V. Indications for Use Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. #### VI. Comparison of Technological Characteristics The navigated instruments are identical to the predicate navigated instruments in that they are both intended to be used during the preparation and placement of implants during spinal surgery. incorporate the same design features to ensure navigation and compatibility with the Medtronic StealthStation® System and NavLock® Tracker to precisely locate anatomical structures, are made from the same materials, and utilize the same sterilization methods. The devices are equivalent in dimensions to the predicate instruments. The table below compare the indications for use and key technological features between the subject and predicate device. | Parameter | Subject Device | Navigated CD Horizon Solera Screwdriver/Taps (K140454) | Analysis | | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Manufacturer | Integrity Implants Inc. | Medtronic Sofamor Danek USA, Inc. | N/A | | | Indications for Use | Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Integrity Implants Navigated Instruments are specifically | Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are | Substantially Equivalent | | | Parameter | Subject Device | | Navigated CD Horizon Solera Screwdriver/Taps (K140454) | Analysis | | Probes and Awls | | designed for use with Medtronic's 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. | 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASET™ System. | | | | Tip Geometry | Trocar tip (Awl) Tapered Straight Probe Duckbilled Straight Probe | Trocar tip (Awl), Tapered (aka Thoracic) Probe Duckbilled (aka Lumber) Probe | Substantially equivalent | | | Materials | Stainless Steel | Stainless Steel | | | Taps | Diameter | 4.0 - 8.5 mm | 3.75 - 8.5 mm | Substantially equivalent | | | Design | Solid or cannulated Dual Lead, Quad Lead | Solid or cannulated Dual Lead | | | | Materials | Stainless Steel | Stainless Steel | | | Drivers | Diameter | 5.5 - 6.0 mm | 5.5 - 6.0 mm | Substantially equivalent | | | Materials | Stainless Steel and Radel | Stainless Steel | Substantially equivalent | | Sterilization | | Non-Sterile | Non-Sterile | Substantially equivalent | {5}------------------------------------------------ {6}------------------------------------------------ #### VII. Performance Data Performance testing of the subject devices, including accuracy testing in accordance with ASTM F2554-18, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems, was completed to ensure the functionality and compatibility of the Integrity Implants Navigated Instruments with the Medtronic StealthStation® Surgical System and the NavLock® Tracker. Registration testing was performed to ensure the instruments can be registered with the StealthStation System. A dimensional analysis was conducted to demonstrate that the subject devices are substantially equivalent to the predicate devices. Cleaning and sterilization validation data from K190360 were leveraged in support of the substantial equivalence determination. ## VIII. Conclusion The information provided above supports that the Integrity Implants Navigated Instruments are as safe and effective as the predicate device. Although minor differences in design and technology exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the Integrity Implants Navigated Instruments are substantially equivalent to the predicate device.