(61 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterilization, and packaging of a titanium mesh, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for reconstruction, stabilization, and rigid fixation of bones, which is a structural and supportive function, not a therapeutic one that treats disease or provides biological healing.
No
The device description indicates it is a titanium mesh used for reconstruction, stabilization, and fixation, which are therapeutic rather than diagnostic functions.
No
The device description explicitly states it consists of "an assortment of titanium meshes," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "reconstruction, stabilization, and/or rigid fixation" of the cranial and maxillofacial skeleton. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as "titanium meshes" used for surgical reconstruction.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
A. Neuro Branch Submission Device
The Universal Mesh is indicated for reconstruction, stabilization, and/or rigid fixation subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).
B. Dental Branch Submission Device
The Universal Mesh is indicated for non-load-bearing reconstruction in the maxillofacial skeleton of patients in whom skeletal growth is complete.
Product codes (comma separated list FDA assigned to the subject device)
GWO, JEY
Device Description
A. Neuro Branch Submission Device
The Universal Mesh - Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh.
The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.
B. Dental Branch Submission Device
The Universal Mesh – Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh.
The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial skeleton, Maxillofacial skeleton
Indicated Patient Age Range
Adults and adolescents (age 12 and higher) for neuro branch; patients in whom skeletal growth is complete for dental branch.
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:
- Biocompatibility Tests: EtO Residuals Test, Cytotoxicity, Endotoxin Testing, Sterilization Validation, Bioburden verification – all passed.
- Packaging Performance: Transportation Test – passed.
- User Validation: System Handling Test – passed.
The subject device met all pre-defined acceptance criteria and standards, and was not found to represent a new worst-case. The results support the proposed substantial equivalence.
Animal testing and Clinical testing were 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
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
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November 6, 2018
Stryker Leibinger GmbH & Co. KG Gregory Gohl Sr. Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, D-79111 De
Re: K182425
Trade/Device Name: Universal Mesh - Sterile Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, JEY Dated: September 5, 2018 Received: September 6, 2018
Dear Gregory Gohl:
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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Matthew C. Krueger -S
for 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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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: | Gregory Gohl
Sr. Regulatory Affairs Specialist
Stryker Craniomaxillofacial (CMF)
750 Trade Centre Way
Portage, MI 49002
Phone: 269-389-4319
Fax: 877-648-7114 |
| Date prepared: | September 5, 2018 |
II. DEVICE [§807.92(a)(2)]
- A. Neuro Branch Submission Device
| Trade Name: | Universal Mesh - Sterile |
|---|---|
| Common or Usual | |
| name: | Bone Plate |
| Classification | |
| Name: | Preformed alterable cranioplasty plate 21 CFR 882.5320 |
| Regulatory Class: | Class II |
| Product Code: | GWO |
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- B. Dental Branch Submission Device
| Trade Name: | Universal Mesh - Sterile |
|---|---|
| Common or Usual | |
| name: | Bone Plate |
| Classification | |
| Name: | Bone Plate; 21 CFR 872.4760 |
| Regulatory Class: | Class II |
| Product Code: | JEY |
*Note the company Stryker or legacy name Stryker Leibinger precedes the product/trade name and predicate device in some documentation.
PREDICATE DEVICE [§807.92(a)(3)] III.
-
A. Neuro Branch Submission Device
Stryker Universal Mesh – K161821 -
B. Dental Branch Submission Device
Stryker Universal Mesh - K170773
DEVICE DESCRIPTION [§807.92(a)(4)] IV.
- A. Neuro Branch Submission Device
The Universal Mesh - Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh.
The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.
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- B. Dental Branch Submission Device
The Universal Mesh – Sterile consists of an assortment of titanium meshes with different dimensions (small 60x60, medium 90x90, and large 120x120 mm) within the framework of the predicate Stryker Universal Mesh.
The design of the meshes is not changed. The only addition is to provide the meshes sterile in a suitable packaging system. These meshes are sterilized by exposure to Ethylene Oxide. The intended use, the principles of operation, and the materials of construction have not changed.
INDICATIONS FOR USE V.
A. Neuro Branch Submission Device
| Subject Device | Predicate Device – K161821 | |
|---|---|---|
| Indications for | ||
| Use | The Universal Mesh is indicated | |
| for reconstruction, stabilization, | ||
| and/or rigid fixation subsequent | ||
| to craniotomy, craniectomy, | ||
| cranioplasty, and cranial fractures | ||
| in adults and adolescents (age 12 | ||
| and higher). | The Universal Mesh is indicated | |
| for reconstruction, stabilization, | ||
| and/or rigid fixation subsequent to | ||
| craniotomy, craniectomy, | ||
| cranioplasty, and cranial fractures | ||
| in adults and adolescents (age 12 | ||
| and higher). |
TABLE 5-1: COMPARISON OF INDICATIONS FOR USE
B. Dental Branch Submission Device
| Subject Device | Predicate - K170773 | |
|---|---|---|
| Indications for | ||
| Use | The Universal Mesh is indicated | |
| for non-load-bearing | ||
| reconstruction in the | ||
| maxillofacial skeleton of patients | ||
| in whom skeletal growth is | ||
| complete. | The Universal Mesh is indicated | |
| for non-load-bearing | ||
| reconstruction in the | ||
| maxillofacial skeleton of patients | ||
| in whom skeletal growth is | ||
| complete. |
TABLE 5-2: COMPARISON OF INDICATIONS FOR USE
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The subject device is compared to its predicate device for substantial equivalence of technological characteristics based on the following criteria:
- A. Principles of Operation
- B. Technological Characteristics
A. Principles of Operation / Operating Principle
The basic operational principle of the Universal Mesh - Cranial (K161821) and the secondary predicate device Universal Mesh- Dental (K170773) remains the same: the Stryker Universal Meshes are designed to aid in the reconstruction and stabilization (plus rigid fixation for the Neuro submission) of the bony areas of the cranial skeleton. The mesh can be modified by cutting and bending instruments for anatomical adaptation. The necessary instrumentation and related product storage are provided by the Stryker Universal Meshes.
B. Technological Characteristics
The fundamental scientific technology of the Universal Mesh - Sterile has not changed. This is because the design of the meshes has not changed. The only addition is to provide the meshes sterile in a suitable packaging system for sterile delivery. The intended use and principles of operation, as well as, materials of construction and operational characteristics have not changed.
- -Intended Use: Same.
- Materials of Construction: The subject meshes are manufactured out of the same material as the predicate device.
- Mechanism of Action: Same. -
- -Mode of Fixation: Same.
- Packaging: The subject device is delivered sterile while the predicate device is dispensed non-sterile.
Overall, the change does not alter the subject device significantly and does not represent a new worst case in design.
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VII. PERFORMANCE DATA
Based on the Risk Analysis performed on the modifications to the Stryker Universal Mesh, bench testing was performed in support of the substantial equivalence determination.
There is no change in the design, material, manufacturing process, or duration/location of contact. The only change is to provide the meshes sterile by Ethylene Oxide sterilization. The performed tests were therefore designed to prove that the chosen packaging is suitable to encompass the meshes and maintain sterility. The performance of the sterilization cycle at Steris was evaluated, as well.
Performance Bench Testing
| Characteristic | Test | Result |
|---|---|---|
| Biocompatibitily | EtO Residuals Test | Passed |
| Biocompatibitily | Cytotoxicity | Passed |
| Biocompatibitily | Endotoxin Testing | Passed |
| Biocompatibitily | Sterilization Validation | Passed |
| Biocompatibitily | Bioburden verification | Passed |
| Packaging Performance | Transportation Test | Passed |
| User Validation | System Handling Test | Passed |
The following performance bench tests were completed.
The subject device met all pre-defined acceptance criteria and standards. The subject device was not found to represent a new worst-case. 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.
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VIII. CONCLUSIONS
The results of the non-clinical data demonstrate that the modified Stryker Universal Mesh resulting in Universal Mesh - Sterile will perform as intended in the specified use conditions. The intended use, principles of operation, and fundamental scientific technology of the Universal Mesh - Sterile has not changed compared to the predicate device. This is because the design of the meshes has not changed. The only addition is to provide the meshes sterile in a suitable packaging system. 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.