K Number

Device Name

GBR System

Manufacturer

JEIL MEDICAL CORPORATION

Date Cleared

2015-06-10

(163 days)

Product Code

JEY DZL

Regulation Number

872.4760

Intended Use

The GBR System is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

Device Description

The GBR System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The GBR System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V). The device screw is available in three different types, Auto Screw, Tenting Screw and GBR Screw. The device plate is provided in two different types, mesh plate and GBR mesh plate. The device system also includes various manual surgical instruments, such as mesh puncher, screwdriver handle, screw block, driver shaft and drill bit. The GBR System is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The GBR System is provided as silver color which is casted according to the anodizing technique while apply 5 V ~ 10 V electric energy to the titanium.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K050669

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.

Therapeutic

No
The device, the GBR System, is intended for stabilizing and fixating bone filling material and barrier membranes for guided bone/tissue regeneration. This is a structural support function, not a direct therapeutic action to treat or cure a disease or condition.

Diagnostic

The device description indicates it is a system of plates, screws, and surgical instruments used for stabilizing and fixating bone filling material and barrier membranes, which are interventional actions, not diagnostic.

SaMD (Software as a Medical Device)

The device description explicitly details physical components made of titanium (plates, screws, surgical instruments) and mentions sterilization requirements, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
GBR System Function: The GBR System is a surgical device intended for stabilizing and fixating bone filling material and barrier membranes within the oral cavity during guided bone/tissue regeneration procedures. It is a physical implant/fixation system, not a device that analyzes biological samples.
Device Description: The description clearly outlines plates, screws, and surgical instruments used for physical fixation, not for laboratory testing.

The intended use and device description clearly indicate that this is a surgical device used directly on the patient's anatomy, not a device used to perform tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The GBR System is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

The GBR System is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

Product codes (comma separated list FDA assigned to the subject device)

JEY, DZL

Device Description

The GBR System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The GBR System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The GBR System is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery.

The device screw is available in three different types: Auto Screw, Tenting Screw, and GBR Screw.

The Auto Screw is for stabilizing the mesh plate.
The GBR Auto Screw has a wide head design which is well suited for GBR mesh. It is provided with head diameter 2.5 mm or 3.0 mm, thread diameter 1.4 mm, and length from 3.0 mm to 12.0 mm.
The Auto Screw is provided with head diameter 2.0 mm or 2.5 mm, thread diameter 1.4 mm or 1.6 mm, and length from 3.0 mm to 12.0 mm.
The Tenting Screw is comprised of a body and a cap. It is effective in maintaining the space between the mesh and the bone. The Tenting Screw is provided with head diameter 2.7 mm, thread diameter 1.4 mm and length 10.0 mm.

The device plate is provided in two different types: mesh plate and GBR mesh plate.

The Mesh Plate is very thin, soft and elastic but has a strong membrane with good suture retention. The extremely high flexibility of this mesh plate allows free fitting, even to irregular surfaces.
The GBR Mesh Plate is suited for horizontal and vertical bone volume augmentation of implant sites using guided bone. The GBR Mesh Plate is suitable for multi-case situations; the product allows bone formation and spatial retention for stable implant. The GBR Mesh Plate has flexibility with thin thickness, and the pre-cut design makes the desired shape form easier.

The device system also includes various manual surgical instruments, such as mesh puncher, screwdriver handle, screw block, driver shaft and drill bit.

The GBR System is provided as silver color which is casted according to the anodizing technique while apply 5 V ~ 10 V electric energy to the titanium.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A non-clinical evaluation, based on ASTM F543-13, has been done. The following tests were performed with the predicate devices:

Driving torque test per ASTM F543-13
Axial pull-out test per ASTM F543-13
Torsion test per ASTM F543-13
Tensile Strength - Plate

The results of this testing indicate that the GBR System is equivalent to the predicate device. No clinical studies were considered necessary and performed.

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.

K050669

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

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

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2018

Jeil Medical Corporation Ms. Hyeroung Lee RA Manager 702-706, 804, 805,807, 812-HO, 55, Digital-ro34-gil, Guro-gu, Seoul, 152-728 Korea

Re: K143730

Trade/Device Name: GBR System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: May 8, 2015 Received: May 11, 2015

Dear Ms. Lee:

This letter corrects our substantially equivalent letter of June 10, 2015

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.

Page 2 - Ms. Lee

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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K143730

Device Name

GBR System

Indications for Use (Describe) Indications for Use (Describe)

The GBR System is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

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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Image /page/3/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by the address and contact information. The address is 5, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea. The phone number is +82 2 850 3500, and the fax number is +82 2 850 3535.

K143730 510(k) Summary

[As required by 21 CRF 807.92]

1. Date Prepared: 4 June 2015

2. Submitter's Information

• Name of Sponsor:	Jeil Medical Corporation
- Address:	702•703•704•705•706•804•805•807•812-ho,
55, Digital-ro34-gil, Guro-Gu, Seoul, 152-728,
Korea
• Contact Name:	Hyeroung LEE (Ms.) / RA Manager

+82 2 850 3535

carine@jeilmed.co.kr

Telephone: +82 2 850 3500 -
- Fax:
- Email Address: -
. Registration Number: 3004049923
Name of Manufacturer: Same as Sponsor
- Same as Sponsor i Address:

3. Trade Name, Common Name, Classification

Trade Name: GBR System .
Common Name: Bone Screw, Bone Plate .

Product Code	Device Name	Device Classification	Regulation Number	Regulation Description
JEY	Plate, Bone	2	872.4760	Bone Plate
DZL	Screw, Fixation
Intraosseous	2	872.4880	Intraosseous Fixation
Screw or Wire

4. Identification of Predicate Device(s)

The identified predicate device within this submission is shown as follows:

510(k) Number: ● K050669
. Applicant: Jeil Medical Corporation
Common Name: Bone Screw, Bone Plate ●
Device Name: Jeil Bone Fixation System

There are no significant differences between the Model GBR System and the predicate

device that would adversely affect the use of the proposed device. It is equivalent to the predicate in design, function, materials, and operational principles as internal fixation components.

5. Description of the Device

The GBR System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follows:

	Screw		Plate
	Auto
Screw	GBR Auto
Screw	Tenting
Screw	Mesh Plate	GBR
Mesh
Type/
Configuration	14-AT-003,
14-AT-004,
14-AT-005,
14-AT-006,
14-AT-008,
14-AT-010,
14-AT-012,
16-AT-003,
16-AT-004,
16-AT-005,
16-AT-006,
16-AT-008,
16-AT-010,
16-AT-012	14-AT-003G,
14-AT-004G,
14-AT-005G,
14-AT-006G,
14-AT-008G,
14-AT-010G,
14-AT-012G,
14-AT-003G-25,
14-AT-004G-25,
14-AT-005G-25,
14-AT-006G-25,
14-AT-008G-25,
14-AT-010G-25,
14-AT-012G-25	16-TT-010	12-ME-001-01,
12-ME-001-02,
12-ME-002-01,
12-ME-002-02,
12-ME-003-01,
12-ME-003-02,
12-GM-001-01,
12-GM-001-02,
12-GM-002-01,
12-GM-002-02	12-GM-P01,
12-GM-P02,
12-GM-J01,
12-GM-L01
Material	ASTM F136, Titanium Alloy (Ti-6Al-4V)		ASTM F67, Unalloyed Titanium

The GBR System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67. Standard Specification for Unalloved Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surqical implants with well-known biocompatibility.

The device screw is available in three different types, Auto Screw, Tenting Screw and GBR Screw. The Auto Screw is for stabilizing the mesh plate. The GBR Auto Screw has wide head design which is well suited for GBR mesh. The Tenting Screw is comprised with a body and a cap. It is effective in maintaining the space between the mesh and the bone.

The GBR Auto Screw is provided with head diameter 2.5 mm or 3.0 mm, thread diameter . 1.4 mm, and length from 3.0 mm to 12.0 mm.
. The Auto Screw is provided with head diameter 2.0 mm or 2.5 mm, thread diameter 1.4 mm or 1.6 mm, and length from 3.0 mm to 12.0 mm
. The Tenting Screw is proved with head diameter 2.7 mm, thread diameter 1.4 mm and length 10.0 mm.

The device plate is provided in two different types, mesh plate and GBR mesh plate.

. The Mesh Plate is very thin, soft and elastic but has strong membrane with good suture retention. The extremely high flexibility of this mesh plate allows free fitting, even to irreqular surfaces.
. The GBR Mesh Plate is suited for horizontal and vertical bone volume augmentation of implants sites using guided bone. The GBR Mesh Plate is suitable for multi-case situations; the product allows bone formation and spatial retention for stable implant. The GBR Mesh Plate has flexibility with thin thickness, and the pre-cut design makes the desired shape form easier.

The device system also includes various manual surgical instruments, such as mesh puncher, screwdriver handle, screw block, driver shaft and drill bit.

The GBR System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The GBR System is provided as silver color which is casted according to the anodizing technique while apply 5 V ~ 10 V electric energy to the titanium.

Screw
Type	Catalog Number	510(k) Number
Auto
Screw	14-AT-003,
14-AT-004,
14-AT-006,
14-AT-008,
14-AT-010,
14-AT-012,
16-AT-004,
16-AT-006,
16-AT-008,
16-AT-010,	K050669
	14-AT-005,
16-AT-003,
16-AT-005,
16-AT-012	K143730

Image /page/6/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic with blue, green, and orange elements, followed by the text "JEIL" in a bold, orange font. To the right of "JEIL" is the text "MEDICAL CORPORATION" in a smaller, gray font.

-ro34-gil, Guro-gu, Seoul, Tel : +82 2 850 3500 / Fax : +82 2 850

| GBR Auto
Screw | 14-AT-003G,
14-AT-004G,
14-AT-005G,
14-AT-006G,
14-AT-008G,
14-AT-010G,
14-AT-012G,
14-AT-003G-25,
14-AT-004G-25,
14-AT-005G-25,
14-AT-006G-25,
14-AT-008G-25,
14-AT-010G-25,
14-AT-012G-25 | K143730 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Tenting
Screw | 16-TT-010 | K143730 |
| Plate | | |
| Type | Catalog Number | 510(k) Number |
| Mesh
Plate | 12-ME-001-01,
12-ME-001-02, | K050669 |
| | 12-ME-002-01,
12-ME-002-02,
12-ME-003-01,
12-ME-003-02,
12-GM-001-01,
12-GM-001-02,
12-GM-002-01,
12-GM-002-02 | K143730 |

The GBR System is consisted of a previously cleared screw and plate (K050669) as well as new screws and plates with different lengths and sizes.

The new types of Auto Screw include different lengths for user's convenience. For 14-ATseries, we added a new product with a length of 5mm. For 16-AT-series, we added products with lengths of 3mm, 5mm, and 12mm. Also, for the new type of GBR Auto Screw, the diameter of the screw head was extended so that it would improve the stability when fixing the mesh plate. The new type of Tenting Screw is for implanting the screw body during Guided Bone Regeneration procedure and it is also for fixing the Plate through the Cap Screw in order to maintain enough space for bone graft materials.

General Information

Image /page/7/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea. The phone and fax numbers are also listed: Tel: +82 2 850 3500 / Fax: +82 2 850 3535.

The new types of mesh plates include various products with different sizes, thickness, and pore sizes for the user's convenience. 12-GM-P01 and 12-GM-P02 of the new types of GBR Mesh Plates are designed to be used together when Guided Bone Regeneration procedure is needed during dental implant surgery. 12- GM-J01 and 12-GM-L01 are the new types with slots for easy modification to suit the surgical site.

6. Intended Use

The GBR System is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

7. Technological Characteristics

The GBR System is a rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follows:

				Unit (mm)
Type		Head Diameter	Thread Diameter	Length
Auto Screw		Ø 2.0, 2.5	Ø 1.4, 1.6	3, 4, 5, 6, 8, 10, 12
GBR Auto Screw		Ø 2.5, 3.0	Ø 1.4	3, 4, 5, 6, 8, 10, 12
Tenting	Body	Ø 2.7	Ø 1.6	10
Screw	Cap	Ø 2.5	Ø 1.4	1.6

· Screw

• Plate

Unit (mm)

Type	Size	Thickness
Mesh
Plate	ME	37.0 * 24.0
49.0 * 37.0
99.0 * 74.0	0.1
0.2	Ø 1.48 ~ 1.88
	GM	37.0 * 25.1
75.0 * 51.0	0.1
0.2	Ø 0.8
GBR Mesh Plate		16.6 * 10.0
28.0 * 10.0
53.0 * 29.0
41.0 * 21.9	0.15	Ø 0.8

Non-Clinical Test Summary:

A non-clinical evaluation, based on ASTM F543-13, has been done. The evaluation of the applicable market data showed that the bone screw does not pose known or new clinical concerns from the similar medical devices that are currently on the market. Based on those results clinical test have not been executed.

The following tests were performed with the predicate devices:

Driving torque test per ASTM F543-13 . Screws
- Axial pull-out test per ASTM F543-13
  - Torsion test per ASTM F543-13
Tensile Strength . Plate

The results of this testing indicate that the GBR System is equivalent to the predicate device.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

8. Substantial Equivalence

	Proposed	Predicate
Parameter	GBR System	Jeil Bone Fixation
System	Remark
510(k) Number	K143730	K050669	-
Manufacturer	Jeil Medical Corporation	Jeil Medical Corporation	-
Indications for Use	The GBR System is
intended for use in stabilizing
and fixating bone grafts,
bone filling material and/or
barrier membranes used for
guided bone/tissue
regeneration in the oral
cavity.	The Jeil Bone Fixation
System is intended for use in
stabilizing and fixating bone
grafts, bone filling material
and/or barrier membranes
used for guided bone/tissue
regeneration in the oral
cavity.	Same
Parameter	Proposed		Predicate	Remark
	GBR System		Jeil Bone
Fixation
Catalog Number	Bone Plate
12-ME-001-01,
12-ME-001-02,
12-ME-002-01,
12-ME-002-02,
12-ME-003-01,
12-ME-003-02,
12-GM-001-01,
12-GM-001-02,
12-GM-002-01,
12-GM-002-02,

12-GM-P01,
12-GM-P02,
12-GM-J01,
12-GM-L01 | | Bone Plate
12-ME-001-01,
12-ME-001-02 | Performance
Testing |
| | Bone Screw
14-AT-003,
14-AT-004,
14-AT-005,
14-AT-006,
14-AT-008,
14-AT-010,
14-AT-012,
16-AT-003,
16-AT-004,
16-AT-005,
16-AT-006,
16-AT-008,
16-AT-010,
16-AT-012, | | Bone Screw
14-AT-003,
14-AT-004,

14-AT-006,
14-AT-008,
14-AT-010,
14-AT-012,

16-AT-004,

16-AT-006,
16-AT-008,
16-AT-010 | Performance
Testing |

Image /page/9/Picture/0 description: The image contains the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic with green, blue, and gray circles connected by an orange arc. To the right of the graphic, the word "JEIL" is written in orange, followed by "MEDICAL CORPORATION" in gray, stacked on top of each other.

702•703•704•705•706•804•805•807•812-ho, 55, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
Tel : +82 2 850 3500 / Fax : +82 2 850 3535

Image /page/10/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo includes a graphic of three stylized figures in green, blue, and gray, along with the company name in orange and gray. Below the logo is a series of numbers, including 702, 703, 704, 705, 706, 804, 805, 807, and 812.

702-703-704-705-704-705-706-804-805-807-812-ho,
55, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
Tel : +82 2 850 3500 / Fax : +82 2 850 3535

| Parameter | Proposed
GBR System | Predicate
Jeil Bone Fixation | Remark | |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------|------|
| | 14-AT-003G,
14-AT-004G,
14-AT-005G,
14-AT-006G,
14-AT-008G,
14-AT-010G,
14-AT-012G,
14-AT-003G-25,
14-AT-004G-25,
14-AT-005G-25,
14-AT-006G-25,
14-AT-008G-25,
14-AT-010G-25,
14-AT-012G-25,
16-TT-010 | | | |
| Plate Shape | Mesh Type | Mesh Type | Performance
Testing | |
| Plate Thickness | 12-ME/GM-Series-01
: 0.1 mm
12-ME/GM-Series-02
: 0.2 mm
12-GM-Series
: 0.15 mm | 12-ME-Series-01
: 0.1 mm
12-ME-Series-02
: 0.2 mm | Performance
Testing | |
| Screw Type | Self-Drilling,
Tenting | Self-Drilling | Performance
Testing | |
| Screw Diameter | 14-Series: 1.4 mm,
16-Series: 1.6 mm | 14-Series: 1.4 mm,
16-Series: 1.6 mm | Same | |
| Bone plates are used
with general surgical
instrumentation | Yes | Yes | Same | |
| Material | Plate | Titanium (ASTM F67) | Titanium (ASTM F67) | Same |
| | Screw | Titanium Alloy
(ASTM F136) | Titanium Alloy
(ASTM F136) | Same |
| Surface casting | | Plate - Anodizing | Plate - Anodizing | Same |

	Proposed	Predicate
Parameter	GBR System	Jeil Bone
Fixation	Remark
Sterilization	Non-sterile,
Steam sterilization prior
to use	Non-sterile,
Steam sterilization prior
to use	Same
Single Use	Yes	Yes	Same

Some of the plates and screws of the subject devices are the same with several models of predicate device (K050669), but the subject device added more types of plates and screws. When compared to the predicate devices, the GBR System presented in this submission is equivalent, in terms of the following:

Intended Use ●
Technological characteristics
. Operating principle
Design features ●
Performance
Biocompatibility ●
. Materials
Method of sterilization and sterility assurance level ●

9. Conclusion [21 CFR 807.92(b)(3)]

The GBR System is equivalent to currently marketed devices. Both the subject and the predicate devices share the same intended use. The subject device is made of the same materials and has similar dimensions and characteristics as does the predicate device. These devices are manufactured from titanium alloys used generally in this type of bone screw and bone plate device, manufactured and sold around the world. The subject device, the GBR System, is equivalent in design and uses the same principle of operation of the predicate device.

To summarize, the subject device is equivalent in design, material, intended use and function to the predicate device. It is concluded that the information included in this summary supports the substantial equivalence of the subject device.