(29 days)
Not Found
No
The 510(k) summary describes a system of screws and plates for cranial reconstruction and fixation, with modifications focused on the dimensions of the screw and screwdriver blade. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is described as being for "reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures," which describes a structural repair/support function rather than a therapeutic or healing one.
No
Explanation: The device is intended for "reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures," which are therapeutic or reconstructive purposes, not diagnostic.
No
The device description explicitly states the system consists of an implant module containing screws and plates, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures". This describes a surgical implant used directly on the patient's body.
- Device Description: The description details "an implant module... containing various screw, and plate versions and shapes". This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not implanted within the body for structural support or reconstruction.
N/A
Intended Use / Indications for Use
The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
Product codes (comma separated list FDA assigned to the subject device)
HBW, GWO, GXR
Device Description
The Stryker Universal Neuro III System (UN III) is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 or higher). The UN III System consists of an implant module for the respective anatomical and indicated areas with each containing various screw, and plate versions and shapes. This special 510(k) is being submitted due to dimensional modifications to the screw and screwdriver blade. There have been no modifications to the plates, meshes, or other accessory devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non load-bearing bony areas subsequent to craniectomy and cranial fractures
Indicated Patient Age Range
adults and adolescents (age 12 and higher)
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)
Bench testing was performed in support of the substantial equivalence determination.
Performance Bench Tests:
- Self-Retention Test
- Screw Insertion Test
- Life Cycle Test Fatigue (Screwdriver Blade)
- Torque to Failure Test Quasi Static (Screwdriver Blade)
- End User / End Product Test
Key results: The subject device met all pre-defined acceptance criteria. Overall, the results of the performance bench tests support the proposed substantial equivalence of the subject device.
Animal testing was not required.
Clinical testing was not required.
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.
Not Found
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
§ 882.5360 Cranioplasty plate fastener.
(a)
Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of a human figure, represented by three overlapping profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2015
Stryker Craniomaxillofacial Mr. Jonathan Schell Senior Regulatory Compliance Specialist 750 Trade Centre Way, Suite 200 Portage, Michigan 49002
Re: K151387
Trade/Device Name: Stryker Universal Neuro III System: UN III AXS Screw. UN III AXS Screwdriver Blade Regulation Number: 21 CFR 882.5360 Regulation Name: Cranioplasty Plate Fastener Regulatory Class: Class II Product Code: HBW, GWO, GXR Dated: Mav 22, 2015 Received: May 26, 2015
Dear Mr. Schell:
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. 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 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -SFD/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
Indications for Use (Describe)
The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Section 5. 510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER
| 510(k) Owner: | Stryker Leibinger GmbH& Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/ Contact
Person: | Jonathan Schell
Sr. Regulatory Affairs Specialist
Stryker Craniomaxillofacial
750 Trade Centre Way
Portage, MI 49002
Phone: 269-389-5596
Fax: 877-648-7114 |
| Date prepared: | May 22, 2015 |
| II.
DEVICE | |
| Trade Name: | Stryker Universal Neuro III System (also referred to as Universal
Neuro 3 System): UN III AXS Screw, UN III AXS Screwdriver Blade |
| Common or Usual
name: | Neuro Plating System |
| Classification
name: | Cranioplasty Plate Fastener 21 CFR §882.5360
Preformed alterable cranioplasty plate 21 CFR §882.5320
Burr hole cover 21 CFR §882.5250 |
| Regulatory Class: | Class II |
| Product Code: | HBW, GWO, GXR |
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III. PREDICATE DEVICE
Predicate: Stryker Universal Neuro III System - K112557
This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Stryker Universal Neuro III System (UN III) is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 or higher). The UN III System consists of an implant module for the respective anatomical and indicated areas with each containing various screw, and plate versions and shapes. This special 510(k) is being submitted due to dimensional modifications to the screw and screwdriver blade. There have been no modifications to the plates, meshes, or other accessory devices. The following Table 5-1 lists the devices subject to this Special 510(k):
| Article Number | Description |
|---|---|
| 62-15035 | AXS Screwdriver Blade Long |
| 62-15036 | AXS Screwdriver Blade Short |
| 56-15034 | |
| 56-15035 | |
| 56-15036 | |
| 56-15933 | |
| 56-15934 | |
| 56-15935 | |
| 56-17334 | AXS Screw |
| 29-56034 | |
| 29-56035 | |
| 29-56933 | |
| 29-56934 | |
| 29-56935 | Preloaded AXS Screw Disc |
TABLE 5-1 - LIST OF SUBJECT DEVICES
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V. INDICATIONS FOR USE
The Stryker Universal Neuro III System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
The proposed modifications do not alter the Indications for Use statement for the proposed device. The Indications for Use is identical to the predicate device Stryker Universal Neuro III System (K112557).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The modified Universal Neuro III System is compared to its predicate device for substantial equivalence of technological characteristics based on the following criteria:
- A. Principle of Operation
- B. Technological Characteristics
A. Principle of Operation
The basic operational principle of the Stryker Universal Neuro III System (UN III) remains the same: the operating principle for the UN III system is to reconstruct, stabilize and/or provide rigid fixation of non load-bearing areas. Subsequently, the principle of operation of the modified screw device and the screwdriver blade accessory remain the same as the predicate device.
B. Technological Characteristics
The dimensional modification described in this special 510(k) is to the UN III System screw and screwdriver blade accessory. However, the modifications to the UN III screw and screwdriver blade accessory do not alter the technological and operational characteristics of the screw and the screwdriver blade accessory. The technological characteristics remain the same:
- Same operating principle: reconstruct, stabilize and/or provide rigid fixation of non । load-bearing bony areas
- Same mode of fixation: plate fixation with screws -
- Same area of contact and contact duration: the screws have contact to tissue/bone with a duration greater than 30 days; the blades, at worst, may contact breached or compromised surface for less than 24 hours
- Same material: Screw made from titanium alloy (ASTM F136) the blades are made from stainless steel (ASTM F899),
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- -Similar design: The modifications to the UN III screw and screwdriver blade accessory are dimensional specifications.
VII. PERFORMANCE DATA
Based on the Risk Analysis performed on the modifications to the UN III screw device and the modification to the screwdriver blade accessory, bench testing was performed in support of the substantial equivalence determination.
Biocompatibility and sterility testing was not required as a basis for substantial equivalence. There is no change in the material, manufacturing process, duration or location of contact, or reprocessing methods.
Performance Bench Testing
The following performance bench tests were completed.
- -Self-Retention Test
- Screw Insertion Test -
- Life Cycle Test Fatigue (Screwdriver Blade) -
- Torque to Failure Test Quasi Static (Screwdriver Blade) -
- -End User / End Product Test
The subject device met all pre-defined acceptance criteria. Overall, the results of the performance bench tests support the proposed substantial equivalence of the subject device.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
VIII. CONCLUSIONS
The results of the non-clinical data demonstrate that the modified UN III screw and screwdriver blade will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.