Who is the manufacturer of IBS System?

Innobiosurg Co., Ltd. filed the 510(k) submission for IBS System (K220517).

What is the FDA product code for IBS System?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for IBS System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IBS System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IBS System

K220517 · Innobiosurg Co., Ltd. · DZE · Dec 20, 2022 · Dental

Device Facts

Record ID	K220517
Device Name	IBS System
Applicant	Innobiosurg Co., Ltd.
Product Code	DZE · Dental
Decision Date	Dec 20, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Device Story

Endosseous dental implant system comprising fixtures and abutments; used to replace missing teeth and restore chewing function. Fixtures (Magicore/Magicore II) are surgically placed into jawbone; abutments connect to fixtures to support dental prostheses. Operated by dental professionals in clinical settings. Fixtures are provided sterile; abutments are non-sterile and require end-user sterilization. System utilizes internal hex, non-hex, and Morse taper bevel connections. Output is a stable foundation for dental restorations. Benefits include restoration of oral function and aesthetics. Device design and material properties facilitate osseointegration and prosthetic support.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing: biocompatibility (ISO 10993 series), sterilization validation (ANSI/AAMI ST79, ISO 17665), fatigue testing (ISO 14801), and surface characterization (SEM, roughness, composition analysis). Human factors usability evaluation for aseptic presentation was also conducted.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F-136) and Co-Cr-Mo alloy. Surface treatments: RBM (Resorbable Blasted Media) and SLA (sand-blasted, large-grit, acid-etched). Connection: Internal hex, non-hex, Morse taper. Sterilization: Gamma (fixtures), moist heat/autoclave (abutments). Dimensions: Fixture diameters 7.0-8.0mm, lengths 7.0-13.0mm.

Indications for Use

Indicated for patients requiring replacement of missing teeth to restore chewing function, including single or multiple-unit restorations (cement/screw-retained or overdentures) and terminal or immediate abutment support for fixed bridgework. Suitable for one or two-stage surgical procedures with delayed loading.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

Magicore System (K212517)

Reference Devices

Magicore System (K152520)
CCM Abutment System (K173120)
CMI Implant IS System (K181138)
AnyRidge Octa 1 Implant System (K182448)
Magicore II System (K192197)
IBS Implant System II (K200753)

Related Devices

K152520 — Magicore System · Innobiosurg Co., Ltd. · Jan 25, 2016
K220079 — Magicore Narrow System · Innobiosurg Co., Ltd. · Dec 14, 2022
K153350 — IBS Implant System · Innobiosurg Co., Ltd. · May 9, 2016
K192197 — Magicore II System · Innobiosurg Co., Ltd. · Apr 28, 2020
K190637 — Fit & Brilliant Dental Implant System · F&B Technology Co., Ltd. · Jun 19, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620 12/20/22 Re: K220517 Trade/Device Name: IBS System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 21, 2022 Received: November 21, 2022 Dear April Lee: 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220517 Device Name IBS System Indications for Use (Describe) The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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." {3}------------------------------------------------ #### 510(K) Summary #### Submitter InnoBioSurg Co., Ltd. Ga Yun Kim 44-19. Techno 10-ro. Yuseong-gu Daejeon, 34027 Republic of Korea Email: gykim1@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881 #### Device Information - Trade Name: IBS System . - . Common Name: Endosseous Dental Implant - Classification Name: Implant, Endosseous, Root-Form . - Product Code: DZE - . Secondary Product Code: NHA - . Panel: Dental - . Regulation Number: 872.3640 - . Date prepared: 12/20/2022 #### Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate K212517, Magicore System by InnoBioSurg Co., Ltd. # Reference Device K152520, Magicore System by InnoBioSurg Co., Ltd. K173120, CCM Abutment System by InnoBioSurg Co., Ltd. K181138, CMI Implant IS System by Neobiotech Co. Ltd. K182448, AnyRidge Octa 1 Implant System by MegaGen Implant Co. Ltd. K192197, Magicore II System by InnoBioSurg Co., Ltd. K200753, IBS Implant System II by InnoBioSurg Co., Ltd. #### Indication for Use: The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading. #### Official Correspondent Withus Group Inc April Lee 106 Superior Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122 {4}------------------------------------------------ #### Device Description The fixtures and abutments in this system are below: 1) Fixture - Magicore (RBM) - Magicore (RBM Cutting Edge) - Magicore II (SLA) . - Magicore II (SLA Cutting Edge) - 2) Abutment - Magic Angled Abutment (Screw type _Hex, Non-Hex) ● - Magic Motion - Magic Motion Housing ● - Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ● - Magic Multiunit Abutment (Cement type Hex, Non-Hex) - Magic Multiunit Cap . An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched). Below is the fixture dimension range: | Fixture | Platform Diameters (Ø) | Fixture Diameters (Ø) | Cuff Lengths (mm) | Implantable Lengths (mm) | |----------------------------------------------------------|---------------------------|--------------------------|-----------------------|------------------------------------------| | Magicore (RBM) | 5.7 | 7.0 | 1.0, 2.0, 3.0, 4.0 | 11.0 ,12.0 ,13.0 | | Magicore (RBM _ Cutting Edge) | | 7.5 | | 10.0, 11.0, 12.0, 13.0 | | | | 8.0 | | 9.0, 10.0, 11.0, 12.0, 13.0 | | Magicore II (SLA) Magicore II (SLA _ Cutting Edge) | 5.7 | 7.0, 7.5, 8.0 | 1.0, 2.0, 3.0, 4.0 | 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 13.0 | The subject fixtures are provided sterile. #### Below is the abutment dimension range: | Abutments | Uses | Diameter (Ø) | Total Length (mm) | Angle(°) | Surface | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------------------------------|----------|----------| | Magic Angled Abutment (Screw type _Hex, Non-Hex) | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 5.3 | 8.45, 8.96, 9.45, 9.96, 10.45, 10.96, 11.45, 11.96 | 15, 23 | machined | | | | 6.3 | 8.68, 9.32, 9.68, 10.32, 10.68, 11.32, 11.68, 12.32 | | | | Magic Motion | The Magic Motion Abutment is connected with fixture and replace missing teeth to restore chewing function. | 4.0 | 10.61, 11.11, 11.56, 12.06, 12.11, 13.06, 13.11, 14.06, 14.11, 15.06 | - | machined | | Magic Motion Housing | The Magic Motion Housing is connected with magic motion and replace missing teeth to restore chewing function. | 5.16 | 3.3 | - | machined | {5}------------------------------------------------ | Magic Abutment (Screw type _ Hex, Non-Hex) | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 5.2, 5.7, 6.2, 6.7 | 4.51, 5.51, 6.51, 7.51, 8.51 | - | RBM (Blasting) | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|------------------------------------|----------|-------------------| | Magic Abutment (Cement type _ Hex, Non-Hex) | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 5.2, 5.7, 6.2, 6.7 | 6.5, 7.5, 8.5, 9.5, 10.5 | - | RBM (Blasting) | | Magic Multiunit Abutment (Cement type _ Hex, Non-Hex) | The Abutment is connected with fixture and it supports prosthesis which restores tooth function. | 4.8 | 5.7, 6.7, 7.7, 8.7 | 0, 5, 10 | RBM (Blasting) | | | | | 5.66, 6.66, 7.66, 8.66 | 15 | | | | | | 6.0, 7.0, 8.0, 9.0 | 20 | | | | | | 6.237, 7.237, 8.237, 9.237 | 25 | | | | | 5.8 | 5.76, 6.76, 7.76, 8.76 | 0, 5, 10 | | | | | | 5.69, 6.69, 7.69, 8.69 | 15 | | | | | | 5.96, 6.96, 7.96, 8.96 | 20 | | | | | | 6.344, 7.334, 8.334, 9.344 | 25 | | | Magic Multiunit Cap | Caps lead to accurate closure of soft tissue surrounding implant and provide a definite shape and form to gingiva which is aesthetically close to natural look. | 5.4, 6.4 | 4.3 | - | RBM (Blasting) | The abutments are provided non-sterile and packaged separately. The abutments should be sterilized before use by End User sterilization. #### Materials: - The Magicore, Magicore II fixtures, Magic Angled Abutment, Magic Motion Housing, Magic . Abutment, Magic Multiunit Abutment and Magic Multiunit cap are made of Ti-6Al-4V ELI - . The Ball Pin of the Magic Motion is made of Ti-6Al-4V ELI and the body of the Magic Motion is made of Co-Cr-Mo Alloy. {6}------------------------------------------------ ## Summaries of Technological Characteristics & Substantial Equivalence Discussion | 1) Magicore and Magicore II Fixtures | | | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device | Primary predicate | Reference predicate | | Manufacturer | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd | | Device Name | IBS System | Magicore System | Magicore II System | | 510(k) No. | K220517 | K212517 | K192197 | | Indications for use | The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant System can be placed in support of single or multiple- unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading. | The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple- unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate Abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading. | The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multipleunit restorations including; cement retained screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading | | Design | Image: Magicore | Image: Magicore II | Image: Magicore II | | | Cutting Edge Non-Cutting Edge | Cutting Edge Non-Cutting Edge | Cutting Edge Non-Cutting Edge | | Material | Ti-6Al-4V Eli | Ti-6Al-4V Eli | Ti-6Al-4V Eli | | Connection | Internal Hex Non - Submerged | Internal Hex Non - Submerged | Internal Hex Non - Submerged | | Endosseous Implant | Tapered, macro threads | Tapered, macro threads | Tapered, macro threads | | Platform Diameters (Ø) | 5.7 | 5.2 | 4.7, 5.2, 5.7 | | Fixture Diameters (Ø) | 7.0, 7.5, 8.0 | 5.0, 5.5, 6.0, 6.5 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | | Cuff Lengths (mm) | 1.0, 2.0, 3.0, 4.0 | 1.0, 2.0, 3.0, 4.0 | 0, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 | | Implantable Lengths (mm) | 11.0, 12.0, 13.0 10.0, 11.0, 12.0, 13.0 9.0, 10.0, 11.0, 12.0, 13.0 | 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 13.0 | 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 13.0 | | Surface | R.B.M | S.L.A | S.L.A | | Treatment | | R.B.M | | | Surgical Technique | 1 and 2 stage, self-tapping | 1 and 2 stage, self-tapping | 1 stage and 2 stage, self tapping | | Gamma Sterilization | Yes | Yes | Yes | | SE Discussion | The subject IBS System has same indications for Use, material, surface treatment, connection, general shape (Design), surface structure, applied production method and surgical technique as the Primary Predicate, K212517. For SLA surface treatment and Magicore II fixture's design of the subject device, K192197 was added as a reference device. Therefore, subject device and predicate devices are substantially equivalent. | | | # 1) Magicore and Magicore II Fixtures {7}------------------------------------------------ 2) Abutment <Magic Angled Abutment (Screw type _Hex, Non-Hex)> | | Subject Device | Reference Device | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | Neobiotech Co., Ltd. | | Device Name | IBS System | CMI Implant IS System | | Abutment Name | Magic Angled Abutment | IS Angled Abutment | | 510(k) No. | K220517 | K181138 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: [Subject Device Design] | Image: [Reference Device Design] | | Diameter(⌀) | 5.3 6.3 | 4.5, 5.2, 5.7, 6.5 | | Length(mm) | 7.5, 8.03 7.73, 8.37 | 7.0, 8.0 | | Angle (°) | 15, 23 | 15, 25 | | Surface Treatment | Machine- | Tin Coating | | Sterilization | End User Sterilization | End User Sterilization | | SE Discussion | The subject device is similar in indications for Use, fundamental scientific technology, principle of operation, technology, functions, and materials with the identified reference device. The difference between the subject and reference device is the general design. However, it does not affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | ### <Magic Motion> | | Subject Device | Reference Device | Reference Device | |--------------|---------------------------------------------------|------------------------------------|--------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd | InnoBioSurg Co., Ltd. | | Device Name | IBS System | CCM Abutment System | IBS Implant System II | | Product Name | Magic Motion | UCLA Abutment | Magic motion | | 510(k) No. | K220517 | K173120 | K200753 | | Material | Ball Pin (TI-6AL-4V ELI) Body (Co-Cr-Mo Alloy) | POM(Poly Acetal) Co-Cr-Mo Alloy | Titanium Alloy (ASTM F 136) | | Design | Image: Subject Device Design | Image: Reference Device Design | Image: Reference Device Design | {8}------------------------------------------------ | Diameters ( $ø$ ) | 4.0 | 4.0, 4.5, 5.0, 5.5 | 4.0 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------| | Total Length (mm) | 10.61, 11.11, 11.56, 12.06, 12.11, 13.06, 13.11, 14.06, 14.11, 15.06 | 14.0, 15.0, 16.0, 17.0 | 10.05~16.05 | | Surface Treatment | Machine- | N/A | Machine- | | Sterilization | End User Sterilization | End User Sterilization | End User Sterilization | | SE Discussion | The subject device is similar in indications for Use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials (Ball pin) with the identified reference device. The difference between the subject and reference device is the head(Ball Pin) shape changed to more round. This difference is to improve the connection of Magic Motion and Magic Motion Housing and doesn't impact product's substantial equivalence. And the Body materials changed Co-Cr-Mo Alloy. To support the materials, K173120 was added as a reference device. This difference is to improve strength doesn't affect device's fundamental functions and safety; therefore, it is substantial equivalent. | | | ### <Magic Motion Housing> | | Subject Device | Reference Device | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | IBS System | IBS Implant System II | | Product Name | Magic Motion | Magic motion | | 510(k) No. | K220517 | K200753 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: Subject Device Design | Image: Reference Device Design | | Diameters (⌀) | 5.16 | 5.3 | | Total Length (mm) | 3.3 | 3 | | Surface Treatment | Machine- | Machine- | | Sterilization | End User Sterilization | End User Sterilization | | SE Discussion | The subject device is same in indications for Use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials with the identified reference device. The difference between the subject and reference device is diameters and length. The height and diameter are changed from K200753 however, it doesn't impact product's safety and effectiveness. Therefore, it is substantially equivalent. | | {9}------------------------------------------------ | | Subject Device | Primary Predicate | Reference Device | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | InnoBioSurg Co., Ltd. | | Device Name | IBS System | Magicore System | Magicore System | | Product Name | Magic Abutment | Magic Abutment | Magicore | | 510(k) No. | K220517 | K212517 | K152520 | | Material | TI-6AL-4V ELI | TI-6AL-4V ELI | TI-6AL-4V ELI | | Design | Image: Hex design Image: Non-Hex design | Image: Hex design Image: Non-Hex design | Image: Screw design | | Diameters (Ø) | 5.2, 5.7, 6.2, 6.7 | 5.2, 5.7, 6.2, 6.7 | 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 | | Total Length(mm) | 4.51, 5.51, 6.51, 7.51, 8.51 | 4.51, 5.51, 6.51, 7.51, 8.51 | 7.0~13.0 | | Surface Treatment | RBM(Blasting) | Machine- | RBM | | Sterilization | End User Sterilization | End User Sterilization | Gamma Sterilization | | SE Discussion | | | | | The subject device is same in fundamental scientific technology, technology, materials, dimensions, and design with the primary predicate. The difference between the subject and primary device is the surface treatment and sterilization. To support these discrepancies, K152520 was added as reference device. The surface treatment between the subject device and K152520 is exactly same. This surface change is intended to only improve scanning surface area and does not affect the actual equivalence of the product. Therefore, it is substantially equivalent. | | | | <Magic Abutment (Screw type _ Hex, Non-Hex)> | <Magic Abutment (Cement type _ Hex, Non-Hex)> Subject Device | | | Primary Predicate | | Reference Device | |-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------|-----------------------|------------------------------| | Manufacturer | InnoBioSurg Co., Ltd. | | InnoBioSurg Co., Ltd. | | InnoBioSurg Co., Ltd. | | Device Name | IBS Implant System | | Magicore System | | Magicore System | | Product Name | Magic Abutment…