Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system of plates and screws for surgical fixation, with no mention of software, algorithms, or any technology related to AI or ML.

Therapeutic

Yes.
The device is intended for the osteotomy, stabilization, and rigid fixation of craniomaxillofacial and mandibular fractures and reconstruction, which actively treats a medical condition.

Diagnostic

No
The device is a system of plates and screws used for the surgical fixation and reconstruction of craniomaxillofacial and mandibular fractures, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of physical components (plates and screws made of titanium) and describes performance testing related to these physical components (torque, strength, sterilization, biocompatibility). There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The description clearly states that this device is a system of plates and screws intended for the surgical fixation and reconstruction of bones in the craniomaxillofacial region and mandible. This is a surgical implant, not a device used for testing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.

This device is a surgical implant used directly on the patient's body for structural support and fixation.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

JEY

Device Description

The subject device (combination of Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263)) consists of multiple modules including fracture and reconstruction modules. The modules consist of straight, angled, hemi/full mandible bridging, curved, and pre-bent plates. The screws in the modules include 1.2-2.7mm self-tapping, self-drilling, and locking screws that vary from 3mm-42mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Craniomaxillofacial (CMF), mandibular

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

Sterilization Validation (Pre-Vacuum) (DIN EN ISO 14937, DIN EN ISO 17665-1 and ISO/TS 17665-2.): Pass
Sterilization Validation (Flash Gravity) (DIN EN ISO 14937, DIN EN ISO 17665-1 and ISO/TS 17665-2.): Pass
Biocompatibility (ISO 10993-1) for Universal CMF Plates: Pass
Biocompatibility (ISO 10993-1) for Universal CMF Screws: Pass
Insertion Torque (ASTM F543) for Universal CMF Screws: Pass
Removal Torque (ASTM F543) for Universal Mandible and MP System: Pass
Failure Torque (shaft shear test) (ASTM F543) for Universal CMF Screws: Pass
Failure Strength (ASTM F382) for Universal CMF Mid-Face Plates: Pass

Key Metrics

Not Found

Predicate Device(s)

K022185, K014263

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

11/9/2022

Stryker Leibinger GmbH & Co. KG Amelia Kesti Staff Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, Freiburg D-79111 GERMANY

Re: K221855

Trade/Device Name: Universal CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: October 5, 2022 Received: October 7, 2022

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 (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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director 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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K221855

Device Name

Universal CMF System

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 [§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: 11/09/2022

II. DEVICE [§807.92(a)(2)]

Trade Name:	Universal CMF System
Abbreviated Name:	Universal CMF System
Common or Usual Name:	Bone Plates, Bone Fixation Fasteners
Device:	Universal CMF System
Classification Name &
Regulation Description:	Plate, Bone; per 21 CFR §872.4760
	Regulation Medical
Specialty & Review Panel:
Product Code:
Subsequent Prod. Codes:
Regulatory Device Class:	Class II

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III. PREDICATE DEVICE [§807.92(a)(3)]

A. Predicate Devices: The predicate devices for this bundled, traditional 510(k) are:
- 1. Universal CMF System K022185
  - 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
- 1. Stryker NewGen/Universal Mandibular System K014263
  - i. Submission Branch of Predicate Device- Division of Dental, Infection Control, and General Hospital Devices; Office of Device Evaluation, Center for Devices and Radiological Health
IV. DEVICE DESCRIPTION [§807.92(a)(4)]
- 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: Universal CMF System
V. The subject device (combination of Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263)) consists of multiple modules including fracture and reconstruction modules. The modules consist of straight, angled, hemi/full mandible bridging, curved, and pre-bent plates. The screws in the modules include 1.2-2.7mm self-tapping, self-drilling, and locking screws that vary from 3mm-42mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98). See Table 1 below for a summary of dimensions for the subject device and predicates. There is no change to the subject device as part of this submission, only labeling changes.

Table 1: Comparison of Size Ranges Between the Predicate And Subject Devices
Dimension
range or
attribute	Predicate Devices –
K022185 and K014263	Subject Device	Explanation
of differences
Plate Length
(straight and
3D plates
only)	Min 9.35 mm
Max 168.36 mm	Min 9.35 mm
Max 168.36 mm	No differences
in comparison
Screw
Length	Min 2.7 mm
Max 42 mm	Min 2.7 mm
Max 42 mm	No differences
in comparison
Screw	Min 0.8 mm	Min 0.8 mm	No differences

5

Diameter	Max 1.9 mm	Max 1.9 mm	in comparison
Plate Profile	Min 0.3 mm	Min 0.3 mm	No differences
Height	Max 2.85 mm	Max 2.85 mm	in comparison
Plate Main
bar width
(not
applicable
for plates
with double
strip)	Min 0.65 mm
Max 5.5 mm	Min 0.65 mm
Max 5.5 mm	No differences in
comparison
Plate Outer
diameter at
screw hole	Min 3 mm
Max 9 mm	Min 3 mm
Max 9 mm	No differences
in comparison

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VI. INDICATIONS FOR USE [§807.92(a)(5)]

Table 2: Comparison of Indications for Use
	Subject Device	Predicate Device – K022185	Predicate Device – K014263	Equivalence Assessment
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. | The Stryker Leibinger Universal
CMF System is a Cranio-
maxillofacial (CMF) plate and
screw system intended for
osteotomy, stabilization and rigid
fixation of CMF fractures and
reconstruction. | The Stryker Leibinger New
Generation System is a
mandibular plate and screw
system intended for stabilization
and rigid fixation of mandibular
fractures and mandibular
reconstruction. | Similar
The K022185 and
K014263 indications are
kept the same in the new
submission. The
indications listed in the
new submission are the
same as the predicates,
but are labeled as
"Craniomaxillofacial
Implants" and "Mandible
Implants" for K022185
and K014263
respectively. |

*The use of the term "craniomaxillofacial" in the subject device's intended use and indication for use is to maintain alignment with the name of the System. Additionally, the term "craniomaxillofacial" is not intended for cramial use, but rather to address fractures where there is some overlap between the cranial and facial bones. For clinical conditions involving the cranium. Universal Neuro System (K031659) is utilized. This is a separate 510(k) cleared device specifically intended for the cranium and is not part of this K221855 submission.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [§807.92(a)(6)]

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

This submission is intended to demonstrate substantial equivalence for the following proposed changes: changing device name to Universal CMF System, merging indications for use, harmonization to add new sterilization parameters across the subject devices from previous clearances, and labeling changes.

A. Principles of Operation / Operating Principle

The operational principle of the subject device is a plate and screw system intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. The method of site preparation, implant preparation, and fixation remains the same as the predicate devices as there is no change to the device.

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B. Technological Characteristics

The technological characteristics of the subject device remain the same as the predicates. See table 3 below for a comparison of technological characteristics between the predicate and subject devices:

Similar Intended Use and Indication for Use: The K022185 and K014263 indications are kept the same. The indications listed in the subject device are the same as the predicates but are labeled as "Craniomaxillofacial Implants" and "Mandible Implants" for K022185 and K014263 respectively.
-Same Mode of Fixation: There is no change to the mode of fixation of subject device as part of this submission, only labeling changes.

8

Same Materials of Construction: There is no change to the materials of construction to the subject device as part of this submission, only labeling changes.
-Same Design: There is no change to the design of the subject device as part of this submission. This 510(k) is submitted to demonstrate substantial equivalence for the following proposed changes: changing device name to Universal CMF System, merging indications for use, harmonization to add new sterilization parameters across the subject devices from previous clearances, and labeling changes.

| Table 3: Comparison of Technological Characteristics Between the Predicate And Subject Devices | | Predicate Device –
K014263 | Subject Device | Explanation of differences |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate
Device –
K022185 | | | |
| Mode of
fixation | Fixated to bone | Fixated to bone | Fixated to bone | No differences in
comparison |
| Operating
Principle | The operating principle of
the Universal CMF
System is to stabilize or
rigidly fixate bone during
osteotomy for fractures
and reconstruction using
plates and screws. | The operating principle of the
Universal CMF System is to
stabilize or rigidly fixate
mandibular fractures during
mandibular reconstruction
using plates and screws. | The operating principle of
the Universal CMF
System to stabilize or
rigidly fixate
craniomaxillofacial
(CMF) skeleton for
fractures and
reconstructive surgeries
using plates and screws. | This is only a
labeling change,
there is no change
to the product
design or use. The
two prior 510(k)s
are being
combined under
one brand-
Universal CMF
System. |
| Device
materials | Commercially pure
titanium (ASTM F
67-95) and
titanium alloy
(ASTM F136-98) | Commercially pure
titanium (ASTM F 67-
95) and titanium alloy
(ASTM F136-98) | Commercially
pure titanium
(ASTM F 67-95)
and titanium alloy
(ASTM F136-98) | No differences in
comparison |
| Device
design | The Universal
CMF System
(K022185) is a
comprehensive
craniomaxillofacial
titanium plating
system and
includes a wide
selection of
implants for bone
fixation of
craniomaxillofacial
fractures and
reconstruction. The
system consists of
multiple modules
including: 1.2mm
Upperface Plating,
1.7mm Midface
Plating,
Orthognathic
Fixation, and
2.0mm Mini
Plating Modules.
The modules
consist of straight,
angled, curved, | The NewGen/Universal
Mandibular System
(K014263) is a
mandibular plate and
screw system intended
for stabilization and
rigid fixation of
mandibular fractures and
mandibular
reconstruction. The
system consists of
modules including:
2.0mm and 2.3mm
Fracture and
Reconstruction
Modules. The 2.0 and
2.3mm
Fracture/Reconstruction
Modules consist of
straight, angled, curved
plates, and pre-bent
plates for fractures and
hemi/full mandible
bridging plates for
reconstruction. The
screws in the modules
include 2.0mm | The subject device
(combination of
Universal CMF
System (K022185)
and
NewGen/Universal
Mandibular
System
(K014263))
consists of
multiple modules
including fracture
and reconstruction
modules. The
modules consist of
straight, angled,
hemi/full mandible
bridging, curved,
and pre-bent
plates. The screws
in the modules
include 1.2-2.7mm
self-tapping, self-
drilling, and
locking screws
that vary from
3mm- 42mm in | The subject device
is a combination of
the two predicate
devices (Universal
CMF System
(K022185) and
NewGen/Universal
Mandibular
System
(K014263). |
| | plates. The screws
in the modules
include 1.2-2.7mm
diameter self-
tapping, self-
drilling, and
locking screws that
vary from 3mm-
20mm in length.
The plates and
screws are made of
commercially pure
titanium (ASTM F
67-95) and
titanium alloy
(ASTM F136-98). | lag, and locking screws
that vary from 4mm-
42mm in length. The
plates and screws are
made of commercially
pure titanium (ASTM F
67-95) and titanium
alloy (ASTM F136-98). | and screws are
made of
commercially pure
titanium (ASTM F
67-95) and
titanium alloy
(ASTM F136-98). | |
| Size ranges | Screws from
0.8mm to 1.9mm
in diameter and
2.7mm to 42mm in
length.
Plates from
9.35mm to
168.36mm in
length. | Screws from 0.8mm to
1.9mm in diameter and
2.7mm to 42mm in
length.
Plates from 9.35mm to
168.36mm in length. | Screws from
0.8mm to 1.9mm
in diameter and
2.7mm to 42mm in
length.
Plates from
9.35mm to
168.36mm in
length. | No differences in
comparison |
| Method of
sterilization | Provided non-sterile.
Sterilized by end user
using moist heat (steam)
per IFU parameters. | Provided non-sterile. Sterilized
by end user using moist heat
(steam) per IFU parameters. | Provided non-sterile.
Sterilized by end user
using moist heat (steam)
per IFU parameters. | The sterilization
parameters were
harmonized for the subject
device. The method of
sterilization remains the
same. |

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VIII. PERFORMANCE DATA [§807.92(b)(7)]

There are no modifications to the subject device as part of this submission, only labeling changes. The labeling change included a harmonization of the sterilization parameters, testing for this update is outlined below. Table 4 summarizes the sterilization testing performed on the subject device, Table 5 outlines testing conducted under prior clearances (K022185 and K014263) to demonstrate substantial equivalence.

Sterilization and Biocompatibility Testing

The subject device includes single-use medical implants provided non-sterile to the user. Although there were no modifications to the subject device as part of this submission, the sterilization parameters within the IFU (instructions for use) were harmonized. Compared to the predicate devices, the sterilization testing conducted for the subject device has the same sterilization type, source, and validation standards as the predicate devices. Although there is a change in the sterilization parameters listed in the updated IFU for some components of the subject device, the change does not affect the Sterility Assurance Level (SAL) and there is no change to the way the device is provided (device is still provided non-sterile). The change does not affect performance or biocompatibility of the device. The harmonized sterilization parameters for the subject device do not impact sterility of the final end-product, as the harmonization encompasses the previously valid sterilization parameters that were used for the components under prior clearances (K022185 and K014263). A summary of the sterilization testing for the subject device can be found in Table 4 below.

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Table 4: Sterilization Testing
Test	Conclusions
Sterilization Validation (Pre-Vacuum) (DIN EN ISO
14937, DIN EN ISO 17665-1 and ISO/TS 17665-
2.)	Pass
Sterilization Validation (Flash Gravity) (DIN EN ISO
14937, DIN EN ISO 17665-1 and ISO/TS 17665-
2.)	Pass

Performance Bench Testing

The following testing listed in Table 5 was conducted under the prior clearances (K022185, K014263) to demonstrate substantial equivalence.

Product	Test	Result
Universal CMF Plates	Biocompatibility (ISO 10993-1)	Pass
Universal CMF Screws	Biocompatibility (ISO 10993-1)	Pass
Universal CMF Screws	Insertion Torque (ASTM F543)	Pass
Universal Mandible and MP System	Removal Torque (ASTM F543)	Pass
Universal CMF Screws	Failure Torque (shaft shear test) (ASTM F543)	Pass
Universal CMF Mid-Face Plates	Failure Strength (ASTM F382)	Pass

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.

IX. 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. 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 device.