(127 days)
Universal CMF System K221855, MP LeFort I Plates K171364, Stryker Upper-Face AXS Screws and Mid-Face AXS Screws - K172572, Stryker MP, Mandible, HMMF, and MMF AXS Screws - K231599, Stryker Universal Orbital Floor System -K133461, Howmedica and Howmedica Leibinger Bone Screw Washers - K980364, Stryker Universal SMARTLock Hybrid MMF System - K122313, Stryker MMF Screw K050535
No
The summary describes a system of plates and screws for skeletal fixation and focuses on changes related to MRI compatibility. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is intended for stabilization and rigid fixation of bones, fractures, and for reconstruction, which are structural and mechanical functions, not therapeutic. The 'temporary stabilization' and 'indirect stabilization' mentioned are means to facilitate healing, but the device itself does not actively administer therapy or treat a disease state.
No
The device is intended for stabilization and rigid fixation of the craniomaxillofacial skeleton and fractures, which are therapeutic and reconstructive functions, not diagnostic.
No
The device description and intended use clearly describe physical implants (plates and screws) used for stabilization and fixation of the craniomaxillofacial skeleton. The submission focuses on adding MR Conditional status to these physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications for use consistently describe the device as a system of plates and screws for the stabilization and rigid fixation of the craniomaxillofacial skeleton, including fractures and reconstruction. This is a surgical implant used in vivo (within the body) for structural support.
- Device Description: The device description confirms it's a system of implants (plates and screws) and the change is related to their MR conditional status.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the Universal CMF System and its related components described are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Universal CMF System Intended use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for use Craniomaxillofacial Implants The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Mandible Implants The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. MP Lefort I Plates Intended Use The Stryker Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Indications for Use The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy, stabilization, and rigid fixation of LeFort I fractures of the maxillofacial skeleton. Stryker Upper-Face AXS Screws And Mid-Face AXS Screws Indications for Use The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Stryker MP, Mandible, HMMF And MMF AXS Screws -Universal CMF System: Intended Use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for Use
Craniomaxillofacial Implants
The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction.
Mandible Implants
The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.
-Stryker Universal SMARTLock Hybrid MMF System:
Intended Use
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
Indications for Use
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
-Stryker MMF Screw
Intended use
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Indications for use
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Stryker Universal Orbital Floor System
Intended Use
The Stryker Universal Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
Indications for Use
The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.
Stryker Universal Smartlock Hybrid MMF System
Intended use
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
Indications for use
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
Stryker MMF Screw Intended use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Indications for use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Type of Use: Prescription Use (Part 21 CFR 801 Subpart D)
Product codes
JEY, DZL
Device Description
This Bundled. Traditional 510(k) is for a single change the MR status that affects multiple devices and can be assessed during one review. There are no changes to the predicate devices themselves, just the addition to allow MR Conditional use of the implants in scope after MRI compatibility testing was completed. Associated labeling for each Predicate Device is also updated to reflect the MR conditional use of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniomaxillofacial (CMF) skeleton, mandibular, maxillary, maxillofacial skeleton, orbital floor and/or medial wall.
Indicated Patient Age Range
adults and adolescents (age 12 and higher) to patients 15 years of age and older.
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 Bench Testing: Performance testing for displacement force, induced torque, and image artifacts were performed on reference devices that were identified as representative for all devices in scope of this submission. The testing was performed, and the labeling information was derived following ASTM F2503-23, ASTM F2213-17, ASTM F2052-21, and ASTM F2182-19.
A simulation study was performed covering all devices in scope of this submission to determine appropriate scanning times and wait times regarding RF induced heating. The simulation study was performed following ASTM F2182-19 and an additional Human Body Model simulation was conducted for the worst case construct.
All other mechanical performance testing of the devices in scope of this submission are not impacted by the changes in scope of this submission.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Universal CMF System K221855, MP LeFort I Plates K171364, Stryker Upper-Face AXS Screws and Mid-Face AXS Screws - K172572, Stryker MP, Mandible, HMMF, and MMF AXS Screws - K231599, Stryker Universal Orbital Floor System -K133461, Howmedica and Howmedica Leibinger Bone Screw Washers - K980364, Stryker Universal SMARTLock Hybrid MMF System - K122313, Stryker MMF Screw K050535
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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.
Stryker Leibinger GmbH & Co. KG Amelia Kesti Staff Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, D-79111 GERMANY
July 12, 2024
Re: K240651
Trade/Device Name: MRI Universal Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: June 12, 2024 Received: June 12, 2024
Dear Amelia Kesti:
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.
1
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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-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 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.
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-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,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director
2
DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
MRI Universal
Indications for Use (Describe)
Universal CMF System Intended use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for use Craniomaxillofacial Implants The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Mandible Implants The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction. MP Lefort I Plates Intended Use The Stryker Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Indications for Use The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy, stabilization, and rigid fixation of LeFort I fractures of the maxillofacial skeleton. Stryker Upper-Face AXS Screws And Mid-Face AXS Screws Indications for Use The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Stryker MP, Mandible, HMMF And MMF AXS Screws -Universal CMF System: Intended Use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for Use
Craniomaxillofacial Implants
4
The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction.
Mandible Implants
The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.
-Stryker Universal SMARTLock Hybrid MMF System:
Intended Use
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
Indications for Use
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
-Stryker MMF Screw
Intended use
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Indications for use
The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.
Stryker Universal Orbital Floor System
Intended Use
The Stryker Universal Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
Indications for Use
The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older.
Stryker Universal Smartlock Hybrid MMF System
Intended use
The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing.
Indications for use
The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
5
Stryker MMF Screw Intended use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. Indications for use The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion. 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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6
510(k) Summary
This section provides a summary of 510(k) information in accordance with the requirements of 21 CFR 807.92.
I. SUBMITTER [§807.92(a)(1)]
| 510(k) Owner: | Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
D-79111 Freiburg, Germany |
|-------------------|---------------------------------------------------------------------------------------|
| Submitter/Contact | |
| Person: | Amelia Kesti |
Staff Regulatory Affairs Specialist Stryker Craniomaxillofacial (CMF) 1941 Stryker Way Portage, MI 49002
Phone: 269-330-5919
Date prepared: 07/11/2024
- DEVICE [§807.92(a)(2)] II.
| Trade Name: | MRI Universal |
|---|---|
| Abbreviated Name: | MRI Universal |
| Common or Usual Name: | Bone Plates, Intraosseous fixation screw or wire |
| Device: | MRI Universal |
| Classification Name & | |
| Regulation Description: | Plate, Bone; per 21 CFR §872.4760 |
| Regulation Medical | |
| Specialty & Review Panel: | Office of Ophthalmic, Anesthesia, Respiratory, ENT and |
| Dental Devices, Office of Product Evaluation and Quality | |
| (OHT1) / Division of Dental Devices (DHT1B) | |
| Product Code: | Primary product code JEY, Secondary product code DZL |
| Regulatory Device Class: | Class II |
| *Note the company Stryker or legacy name Stryker Leibinger precedes the product/trade name and | |
| predicate device in some documentation. |
7
III. PREDICATE DEVICE [§807.92(a)(3)]
- A. Predicate Devices: The predicate devices for this Bundled, Traditional 510(k) are:
-
- Primary Predicate: Universal CMF System K221855
- i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health
-
- Reference Predicate: MP LeFort I Plates K171364
- i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health
-
- Reference Predicate: Stryker Upper-Face AXS Screws and Mid-Face AXS Screws - K172572
- i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health
-
- Reference Predicate: Stryker MP, Mandible, HMMF, and MMF AXS Screws - K231599
- i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health
-
- Reference Predicate Device: Stryker Universal Orbital Floor System -K133461
- i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health
-
- Reference Predicate Device: Howmedica and Howmedica Leibinger Bone Screw Washers - K980364
- i. Submission Branch of Predicate Device- Division of General and Restorative Devices, Office of Device Evaluation Center for Devices and Radiological Health.
-
- Reference Predicate Device: Stryker Universal SMARTLock Hybrid MMF System - K122313
- i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health
-
- Reference Predicate Device: Stryker MMF Screw K050535
-
8
- i. Submission Branch of Predicate Device- Division of Anesthesiology, General Hospital, Infection Control and Dental Devices; Office of Device Evaluation, Center for Devices and Radiological Health
DEVICE DESCRIPTION [§807.92(a)(4)] IV.
- A. Submission Branch of Subject Device: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Office of Product Evaluation and Quality (OHT1) / Division of Dental Devices (DHT1B)
- B. Subject Device: MRI Universal
This Bundled. Traditional 510(k) is for a single change the MR status that affects multiple devices and can be assessed during one review. There are no changes to the predicate devices themselves, just the addition to allow MR Conditional use of the implants in scope after MRI compatibility testing was completed. Associated labeling for each Predicate Device is also updated to reflect the MR conditional use of the implants.
V. INDICATIONS FOR USE [§807.92(a)(5)]
The proposed modifications do not alter the indications for use statement for the Subject Devices except for the Howmedica Leibinger Bone Washer. The washer individual indication is obsoleted and the washer is moved to the Universal CMF System under this submission. There is no change to any of the Indications for Use or Intended Uses for any of the other Predicate Devices. See Table 5-1 for the complete Indications for Use for each device.
9
K240651
TABLE 5-1: COMPARISON OF INDICATIONS FOR USE
| Aspect | Primary Predicate
Device (K221855)
Universal CMF
System | Additional Predicate
Device (K171364) MP
LeFort Plates | Additional
Predicate Device
(K172572) Stryker
Upper-Face AXS
Screws and Mid-
Face AXS Screws | Additional Predicate Device (K231599) Stryker MP,
Mandible, HMMF and MMF AXS Screws | Additional
Predicate Device
(K133461) Stryker
Universal Orbital
Floor System | Additional Predicate
Device (K980364)
Howmedica and
Howmedica
Leibinger Bone Screw
Washers | Additional Predicate
Device (K122313)
Stryker Universal
SMARTLock Hybrid
MMF System | Additional
Predicate
Device
(K050535)
Stryker MMF
Screw |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Intended Use
The Universal CMF
System is intended for
stabilization and rigid
fixation of the
craniomaxillofacial
(CMF) skeleton. | Intended Use
The Stryker Leibinger
Universal CMF and
Universal 2.0 Mini
Plating Systems are
Craniomaxillofacial
(CMF) plate and screw
systems intended for
osteotomy,
stabilization, and rigid
fixation of CMF
fractures and
reconstruction. | Intended
Use/Indications for
Use
The Stryker
Universal CMF
System is a Cranio-
maxillofacial
(CMF) plate and
screw system for
osteotomy,
stabilization, and
rigid fixation of
CMF fractures and
reconstruction. | Intended Use/Indications for Use
-Universal CMF System:
The Universal CMF System is intended for stabilization
and rigid fixation of the craniomaxillofacial (CMF)
skeleton.
-Stryker Universal SMARTLock Hybrid MMF System:
The Stryker Universal SMARTLock Hybrid MMF
System is intended to be used for temporary stabilization
of mandibular and maxillary fractures in order to
maintain proper occlusion during fracture healing.
-Stryker MMF screw:
The Stryker MMF Screw is intended for use as a bone
screw in the temporary maxillomandibular fixation to
provide indirect stabilization of fractures of the maxilla,
mandible or both, where there is sufficient occlusion. | Intended Use
The Stryker
Universal Orbital
Floor System is
intended to be used
in the reconstruction
of the floor and/or
medial wall of the
orbit. | Intended
Use/Indications for
Use
The washers are
intended to be used to
provide additional
surface area contact
between the screw
head and bone surface,
when used in
combination with bone
screws for small bone
reconstruction of the
mandible, hand, foot,
and the midfacial
skeleton where there
exists a condition of a
thin cortex
osteoporotic bone.* | Intended Use
The Stryker Universal
SMARTLock Hybrid
MMF System is intended
to be used for temporary
stabilization of
mandibular and maxillary
fractures in order to
maintain proper occlusion
during fracture healing. | Intended Use
The Stryker
MMF Screw is
intended for use
as a bone screw
in the
temporary
maxillomandib
ular fixation to
provide indirect
stabilization of
fractures of the
maxilla,
mandible or
both, where
there is
sufficient
occlusion. |
| Indications
for Use
Statement | Indications for Use
Craniomaxillofacial
Implants
The Universal CMF
System is a
Craniomaxillofacial
(CMF) plate and
screw system intended
for osteotomy,
stabilization, and rigid
fixation of CMF
fractures and
reconstruction.
Mandible Implants
The Universal CMF
System (mandible
modules) is a
mandibular plate and
screw system intended
for stabilization and
rigid fixation of
mandibular fractures
and mandibular
reconstruction. | Indications for Use
The MP LeFort I
Plates as part of the
predicate subgroup
Universal 2.0 Mini
Plating System are
implants indicated for
osteotomy stabilization
and rigid fixation of
LeFort I fractures of
the maxillofacial
skeleton. | Indications for Use
The Stryker
Universal CMF
System is a Cranio-
maxillofacial
(CMF) plate and
screw system for
osteotomy,
stabilization, and
rigid fixation of
CMF fractures and
reconstruction. | Indications for Use
-Universal CMF System:
Craniomaxillofacial Implants
The Universal CMF System is Craniomaxillofacial
(CMF) plate and screw system intended for osteotomy,
stabilization, and rigid fixation of CMF fractures and
reconstruction.
Mandible Implants
The Universal CMF System (mandible modules) is a
mandibular plate and screw system intended for
stabilization and rigid fixation of mandibular fractures
and mandibular reconstruction.
-Stryker Universal SMARTLock Hybrid MMF System:
The Stryker Universal SMARTLock Hybrid MMF
System is indicated for the treatment of mandibular and
maxillary fractures in adults and adolescents (age 12 and
higher) in whom permanent teeth have erupted.
-Stryker MMF screw:
The Stryker MMF Screw is intended for use as a bone
screw in the temporary maxillomandibular fixation to
provide indirect stabilization of fractures of the maxilla,
mandible or both, where there is sufficient occlusion. | Indication for Use
The Stryker
Universal Orbital
Floor System is
indicated for
the reconstructive
treatment of orbital
floor and/or medial
wall
trauma or bone
excision in patients
15 years of age and
older. | Indications for Use
The washers are
intended to be used to
provide additional
surface area contact
between the screw
head and bone surface,
when used in
combination with bone
screws for small bone
reconstruction of the
mandible, hand, foot,
and the midfacial
skeleton where there
exists a condition of a
thin cortex
osteoporotic bone.* | Indications for use
The Stryker Universal
SMARTLock Hybrid
MMF System is indicated
for the treatment of
mandibular and maxillary
fractures in adults and
adolescents (age 12 and
higher) in whom
permanent teeth have
erupted. | Indications for
use
The Stryker
MMF Screw is
intended for use
as a bone screw
in the
temporary
maxilloman-
dibular fixation
to provide
indirect
stabilization of
fractures of the
maxilla,
mandible or
both, where
there is
sufficient
occlusion. |
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE [§807.92(a)(6)]
The subject device is compared to its predicate devices 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 operating principle of the Subject Device is identical to the basic operating principle of the Predicate Devices. There are no updates to the Predicate Devices themselves, only the allowance of the MR Conditional use of the plate and screw systems in the MR environment and associated labeling updates.
The fundamental scientific technology of the Subject Device has not changed. This is because the principle of operation, the mechanism of action, the intended use, and the materials of construction have not changed as a result of the MR conditional testing of the existing Predicate Devices.
B. Technological Characteristics
There are no updates to the Predicate Devices themselves, only the allowance of the MR Conditional use of the plate and screw systems in the MR environment and associated labeling updates. The technological characteristics remain the same as the corresponding Predicate Devices:
- Same operating principle -
- -Same mode of fixation
- -Same area of contact and contact duration
- Same material -
VII. PERFORMANCE DATA [§807.92(b)(1)]
There are no modifications to the subject devices as part of this submission, only the allowance of the MR Conditional use of the plate and screw systems in the MR environment and associated labeling updates.
Biocompatibility and sterility testing are not required as a basis for substantial equivalence. There is no change in the subject device material, manufacturing process, duration or location of contact, reprocessing methods, or testing standards followed relative to the Predicate Devices cleared in K221855, K171364, K172572, K231599, K133461, K980364, K122313, and K050535. The testing was performed following ISO 10993-1, DIN EN ISO 14937, DIN EN ISO 17665-1, and ISO/TS 17665-2.
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Performance Bench Testing
Performance testing for displacement force, induced torque, and image artifacts were performed on reference devices that were identified as representative for all devices in scope of this submission. The testing was performed, and the labeling information was derived following ASTM F2503-23, ASTM F2213-17, ASTM F2052-21, and ASTM F2182-19.
A simulation study was performed covering all devices in scope of this submission to determine appropriate scanning times and wait times regarding RF induced heating. The simulation study was performed following ASTM F2182-19 and an additional Human Body Model simulation was conducted for the worst case construct.
All other mechanical performance testing of the devices in scope of this submission are not impacted by the changes in scope of this submission.
Animal Testing
Animal testing was not required as a basis for substantial equivalence.
Clinical Testing [§807.92(b)(2)]
Clinical testing was not required as a basis for substantial equivalence.
VIII. CONCLUSIONS [§807.92(b)(3)]
In summary, the subject device is substantially equivalent to its predicate device. The subject device's fundamental scientific technology, technological characteristics, and materials of construction are the same as the predicate devices. The subject device's intended use and indications for use have the same scope, content and meaning as the predicate devices. There are no new questions of safety or effectiveness. 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 to the predicate devices.