(144 days)
No
The document describes manual surgical instruments used with a navigation system for intraoperative guidance. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the mechanical function of the instruments and their compatibility with the navigation system.
No
The device description states they are "manual surgical instruments used to facilitate placement of Stryker Spine implants," meaning they are tools for surgery, not devices that provide therapy themselves.
No
The device description clearly states that these are "manual surgical instruments (screw inserters and taps)" used to "facilitate placement of Stryker Spine implants." They are accessories to a navigation system for surgical guidance, not for diagnosing medical conditions.
No
The device description explicitly states that the devices are "nonsterile, reusable surgical instruments (screw inserters and taps)," which are physical hardware components. While they are intended to be used with a navigation system (which likely includes software), the devices themselves are not software-only.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that these are manual surgical instruments used during surgery to facilitate the placement of spinal implants within the patient's body. They do not involve testing or analyzing biological samples.
- The intended use is for surgical guidance and implant placement. The descriptions focus on their role as accessories to a surgical navigation system for intraoperative guidance and the physical act of inserting screws and taps into the spine.
- There is no mention of analyzing biological samples or providing diagnostic information. The performance studies focus on functionality, compatibility with the navigation system, and substantial equivalence to predicate surgical instruments, not on diagnostic accuracy or performance related to biological markers.
These devices are surgical instruments used in vivo (within the living body) during a surgical procedure, not in vitro (in glass or outside the living body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Navigated Everest Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Everest Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Everest Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Everest Spinal Fixation System using the Stryker Spine Navigation System.
The Navigated Mesa Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Mesa Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Mesa Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Mesa Spinal Fixation System using the Stryker Spine Navigation System.
The Navigated Yukon Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Yukon Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Yukon Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Yukon Spinal Fixation System using the Stryker Spine Navigation System.
The Navigated Xia 4.5- Xia CT Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 4.5- Xia CT Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 4.5- Xia CT Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 4.5- Xia CT Spinal Fixation System using the Stryker Spine Navigation System.
The Navigated Xia 3- Serrato Deformity Screwdriver is intended to be used as an accessory to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3- Serrato Deformity Screwdriver may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a rigid anatomical structure can be identified.
The Navigated Xia 3- Serrato Deformity Screwdriver is intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine XIA® 3 and ES2® Spinal Fixation Systems using the Stryker Spine Navigation System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Navigated Spine Instruments are nonsterile, reusable surgical instruments (screw inserters and taps) intended to be used when implanting previously cleared components of Mesa, Everest, Yukon, Xia 3, Xia 4.5, and ES2. These instruments are intended to be used with the Stryker Spine Navigation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
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)
Performance testing was conducted to ensure that the Navigated Spine Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Stryker Spine Navigation System using the Rotational Navigation Adapter and associated trackers, and to demonstrate substantial equivalence to the predicate device. The performance of Navigated Spine Instruments has met all acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
March 23, 2021
Image /page/0/Picture/1 description: The image shows 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.
Stryker Spine Megan Callanan Senior Regulatory Affairs Specialist 600 Hope Parkway SE Leesburg, Virginia 20175
Re: K203205
Trade/Device Name: Navigated Spine Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 21, 2020 Received: December 23, 2020
Dear Megan Callanan:
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.
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
1
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 mediation-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,
For: 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) K203205
Device Name Navigated Spine Instruments
Indications for Use (Describe)
Navigated Everest Instruments
The Navigated Everest Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Everest Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Everest Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Mesa Instruments
The Navigated Mesa Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Mesa Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Mesa Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Yukon Instruments
The Navigated Yukon Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Yukon Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Yukon Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Xia 4.5- Xia CT Taps
The Navigated Xia 4.5- Xia CT Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 4.5- Xia CT Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
3
The Navigated Xia 4.5- Xia CT Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 4.5- Xia CT Spinal Fixation System using the Stryker Spine Navigation System.
Navigated Xia 3- Serrato Deformity Screwdriver
The Navigated Xia 3- Serrato Deformity Screwdriver is intended to be used as an accessory to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3-Serrato Deformity Screwdriver may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.
The Navigated Xia 3- Serrato Deformity Screwdriver is intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine XIA® 3 and ES2® Spinal Fixation Systems using the Stryker Spine Navigation System.
| 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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4
K203205
| 510(k) Summary: Navigated Spine Instruments | |
|---|---|
| Submitter: | Stryker Spine |
| 600 Hope Parkway SE | |
| Leesburg, VA 20175 | |
| Contact Person : | Name: Megan Callanan |
| Phone: (551)262-2429 | |
| Email: megan.callanan@stryker.com | |
| Date Prepared: | 10/29/2020 |
| Trade Name: | Navigated Spine Instruments |
| Common Name: | Navigation Instruments |
| Proposed Class: | Class II |
| Classification Name: | Orthopedic / Orthopedic Stereotaxic Instruments |
| Regulation Number | 21 CFR 882.4560 |
| Product Code: | OLO |
| Predicate Devices: | Primary Predicate: K172034 Spine Map 3D 3.1 |
| Additional Predicate: K192911 Brainlab Compatible K2M Navigation Instruments | |
| Reference Predicate: K183196 SpineMap Go | |
| Device Description: | Navigated Spine Instruments are nonsterile, reusable surgical instruments (screw |
| inserters and taps) intended to be used when implanting previously cleared | |
| components of Mesa, Everest, Yukon, Xia 3, Xia 4.5, and ES2. These instruments are | |
| intended to be used with the Stryker Spine Navigation System. | |
| Indications for Use: | Navigated Everest Instruments |
| The Navigated Everest Screw Inserters and Taps are intended to be used as | |
| accessories to the Stryker Spine Navigation System. They are manual surgical | |
| instruments used to facilitate placement of Stryker Spine implants. | |
| The Navigated Everest Screw Inserters and Taps may be used as part of the Stryker | |
| Spine Navigation System, which is indicated for any medical condition in which the | |
| use of computer assisted planning and surgery may be appropriate. The System can | |
| be used for intraoperative guidance where a reference to a rigid anatomical structure | |
| can be identified. | |
| The Navigated Everest Screw Inserters and Taps are intended for use with Rotational | |
| Navigation Adapter and associated trackers to facilitate the placement of screws of | |
| the Stryker Spine Everest Spinal Fixation System using the Stryker Spine Navigation | |
| System. | |
| 510(k) Summary: Navigated Spine Instruments | |
| Navigated Mesa Instruments | |
| The Navigated Mesa Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants. | |
| The Navigated Mesa Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. | |
| The Navigated Mesa Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Mesa Spinal Fixation System using the Stryker Spine Navigation System. | |
| Navigated Yukon Instruments | |
| The Navigated Yukon Screw Inserters and Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants. | |
| The Navigated Yukon Screw Inserters and Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. | |
| The Navigated Yukon Screw Inserters and Taps are intended for use with Rotational Navigation Adapter and associated trackers to facilitate the placement of screws of the Stryker Spine Yukon Spinal Fixation System using the Stryker Spine Navigation System. | |
| Navigated Xia 4.5- Xia CT Taps | |
| The Navigated Xia 4.5- Xia CT Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants. | |
| The Navigated Xia 4.5- Xia CT Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used |
5
6
| 510(k) Summary: Navigated Spine Instruments | |
|---|---|
| for intraoperative guidance where a reference to a rigid anatomical structure can be | |
| identified. | |
| The Navigated Xia 4.5- Xia CT Taps are intended for use with Rotational Navigation | |
| Adapter and associated trackers to facilitate the placement of screws of the Stryker | |
| Spine Xia 4.5- Xia CT Spinal Fixation System using the Stryker Spine Navigation | |
| System. | |
| Navigated Xia 3- Serrato Deformity Screwdriver | |
| The Navigated Xia 3- Serrato Deformity Screwdriver is intended to be used as an | |
| accessory to the Stryker Spine Navigation System. They are manual surgical | |
| instruments used to facilitate placement of Stryker Spine implants. | |
| The Navigated Xia 3- Serrato Deformity Screwdriver may be used as part of the | |
| Stryker Spine Navigation System, which is indicated for any medical condition in | |
| which the use of computer assisted planning and surgery may be appropriate. The | |
| System can be used for intraoperative guidance where a reference to a rigid | |
| anatomical structure can be identified. | |
| The Navigated Xia 3- Serrato Deformity Screwdriver is intended for use with | |
| Rotational Navigation Adapter and associated trackers to facilitate the placement of | |
| screws of the Stryker Spine XIA® 3 and ES2® Spinal Fixation Systems using the | |
| Stryker Spine Navigation System. | |
| Summary of the | |
| Technological | |
| Characteristics | The subject Navigated Spine Instruments have the same technological characteristics |
| as the predicate device including design, material composition, intended use, function, | |
| and range of sizes. Biocompatibility of patient-contacting materials was demonstrated | |
| by using well characterized materials that meet applicable standards. | |
| Summary of the | |
| Performance Data | Performance testing was conducted to ensure that the Navigated Spine Instruments |
| are acceptable for their intended use, to ensure functionality and compatibility with | |
| the Stryker Spine Navigation System using the Rotational Navigation Adapter and | |
| associated trackers, and to demonstrate substantial equivalence to the predicate | |
| device. The performance of Navigated Spine Instruments has met all acceptance | |
| criteria. | |
| Conclusion | Stryker Navigated Spine Instruments are substantially equivalent to |
| the noted predicate device as they have the same intended use, technological | |
| characteristics, safety and efficacy profile, and performance specifications. | |
| The content of this submission supports the determination of substantial | |
| equivalence. |