T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button

Q: Who is the manufacturer of T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

Healthium Medtech Limited filed the 510(k) submission for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (K231404).

Q: What is the FDA product code for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

Q: What is the regulatory pathway for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

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

Q: Who can help prepare an FDA 510(k) submission like T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

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.

K231404 · Healthium Medtech Limited · MBI · Aug 4, 2023 · Orthopedic

Device Facts

Record ID	K231404
Device Name	T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
Applicant	Healthium Medtech Limited
Product Code	MBI · Orthopedic
Decision Date	Aug 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction.

Device Story

Cortical tibial suspension fixation device; used for ligament/tendon repair and reconstruction (ACL/PCL). Components include PEEK button and UHMWPE adjustable loop. Closed button version preloaded with loop; open button version non-preloaded. Implanted by orthopedic surgeons via endoscopic or open surgical approaches. Functions as fixation post or distribution bridge to secure soft tissue to bone. Provides mechanical fixation for graft healing. Benefits include biocompatible PEEK material with modulus of elasticity similar to cortical bone, reducing potential for graft damage compared to metallic alternatives.

Clinical Evidence

Bench testing only. No clinical data. Testing included pull-out strength, cyclic loading, biocompatibility (sensitization, reactivity, pyrogenicity, systemic toxicity, cytotoxicity), and implantation studies (bone/intramuscular). Results demonstrate performance statistically equivalent to predicate devices.

Technological Characteristics

Materials: PEEK (button), UHMWPE (loop), Loctite 4014 (additive in open button suture button). Principle: Cortical suspension fixation. Form factor: 16mm diameter x 7.5mm height buttons. Sterilization: ETO. Single-use, non-absorbable.

Indications for Use

Indicated for fixation of bone to bone or soft tissue to bone in knee ligament repair and reconstructive procedures, specifically ACL/PCL repair and reconstruction.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II (K221128)

Reference Devices

ANCHORMAN Tibial Ligament Fixation Device (K170388)

Related Devices

K150416 — ProCinch Adjustable Loop Device · Stryker Endoscopy · Apr 17, 2015
K210078 — Stryker ProCinch Adjustable Loop Device · Stryker Endoscopy · Mar 11, 2021
K070780 — CONMED LINVATEC XO BUTTON · Conmed Linvatec · Aug 21, 2007
K202291 — Button Loop · Yunyi (Beijing) Medical Device Co., Ltd. · Jan 8, 2021
K221128 — Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II · Arthrex, Inc. · Oct 5, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ August 4, 2023 Image /page/0/Picture/1 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, 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. Healthium Medtech Limited Pankaj Dawar, PhD Deputy General Manager Regulatory Affair 472-D, 13th Cross, 4th Phase, Peenya Industrial Area Bangalore, Karnataka 560058 India Re: K231404 Trade/Device Name: T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 15, 2023 Received: May 15, 2023 Dear Dr. Dawar: 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. 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 {1}------------------------------------------------ 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, # Jesse Muir -S Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ### Device Name T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button ### Indications for Use (Describe) T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button are to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------|--| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div> ☐ 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in bold, black letters, with the "O" in "SIRONIX" being a red circle. Below "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, black font. K231404 Image /page/3/Picture/3 description: The image contains the word "Healthium" in a bold, blue font. To the right of the word is a logo that consists of a blue circle with a white cross inside. The top right corner of the logo has an orange section. # T-Button® Adjustable Loop UHMWPE Suture PEEK Button ### 1. 510(k) Summary #### Submitter Information: 1.1. | Application Correspondent: | PANKAJ DAWAR Healthium Medtech Limited 472-D, 13th Cross, 4th Phase, Peenya Industrial Area, Bangalore Karnataka 560058, India | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Phone: | +91-9886529934 | | E-mail: | pankaj.d@healthiummedtech.com | | Specification Developer: | Healthium Medtech Limited 472-D, 13th Cross, 4th Phase, Peenya Industrial Area, Bangalore, Karnataka 560058, India | | Phone: | +91 - 80 - 41868000 | | Contact Person: | PANKAJ DAWAR | | E-mail: | pankaj.d@healthiummedtech.com | | Date Prepared: | 01-08-2023 | | 1.2. Device Identification: | | | Device Trade Name: | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button | | Device Common Name: | Non-Absorbable Cortical Fixation | | Classification Name: | Smooth or threaded metallic bone fixation fastener | | Device Class: | Class II | | Regulation Number: | 21 CFR 888.3040 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font. Image /page/4/Picture/2 description: The image shows the Healthium logo. The logo consists of the word "Healthium" in blue, with two overlapping circles to the right. The top circle is orange, and the bottom circle is blue. A white cross is formed where the circles overlap. #### 1.3. Predicate Devices: | Device Name | Predicate | 510(k) Number | |--------------------------------------------------------------|---------------------|---------------| | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | Primary Predicate | K221128* | | ANCHORMAN Tibial Ligament Fixation Device | Reference Predicate | K170388 | Table 1 - List of Predicate Devices ### * In K221128, Arthrex ACL TightRope® has been selected as the Primary Predicate. #### 1.4. Device Description The T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is a permanently implantable Polyether Ether Ketone (PEEK) cortical tibial suspension fixation device which provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgeries and repair. The fixation device allows for endoscopic or open ligament reconstruction approaches. The Closed button is preloaded with UHMWPE adjustable loop and in Open Button the UHMWPE adjustable loop is non preloaded. #### 1.5. Intended Use & Indications for Use The T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction. #### 1.6. Comparison of Technological Characteristics The fundamental technology characteristics such as Design and Materials of construction are compared between the T-Button® A Adjustable Loop UHMWPE Suture PEEK Button. Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button with the primary predicate device Arthrex ACL Tightrope. The Reference Predicate device (K170388) "ANCHORMAN Tibial Ligament Fixation Device" has the same material of construction as that of the subject devices i.e. PEEK Table 2 summarizes the comparison of technological characteristics between the subject and predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller font. T-Button® Adjustable Loop UHMWPE Suture PEEK Button Image /page/5/Picture/3 description: The image contains the logo for Healthium. The logo consists of the word "Healthium" in a blue sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one blue. The blue circle is positioned slightly below and to the left of the orange circle. # Table 2 – Substantial Equivalence Table | S. No | Parameters | Arthrex ACL TightRope® (K221128) (Primary Predicate) | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (Subject Device) | Comments | |-------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | 1. | Manufacturer | Arthrex Inc. | Healthium Medtech Limited | - | | 2. | Product Code | MAI (Classification Product Code) MBI (Subsequent Product Code) | MBI | As the subject device is nondegradable so only MBI code is applicable. | | 3. | Regulation Number | 21 CFR 888.3030 21 CFR 888.3040 | 21 CFR 888.3040 | Similar to primary predicate device according to MBI code. | | 4. | Classification | Class II | Class II | Similar to predicate device | | 5. | Intended Use/Indications for Use | The Arthrex ACL TightRope ®, device is intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these devices for ACL/PCL repair and | The Adjustable Loop UHMWPE Suture PEEK Button (Close Button & Open Button) are to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. This device is employed in Knee ligament repair and reconstructive procedures, specifically for ACL/PCL repair and reconstruction. | Similar to primary predicate device excluding the pediatric patient indications | | Healthium Medtech Limited | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India www.healthiummedtech.com CIN: U03311KA1992PLC013831 | Page 3 of 10 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" represented by a red circle. Below the company name, the words "Arthroscopy Solutions" are written in a smaller, lighter font. T-Button® Adjustable Loop UHMWPE Suture PEEK Button | S. No | Parameters | Arthrex ACL TightRope® (K221128) (Primary Predicate) | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (Subject Device) | Comments | |-------|-----------------|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | | | reconstruction for the adult and pediatric patient population. | | | | 6. | Button Material | Titanium | PEEK | SE Analysis 1 | | 7. | Loop Material | UHMWPE | Closed Button Loop: UHMWPE Open Button Loop: Non-absorbable, UHMWPE (UHMWPE 100.0%) + Suture Button: (Non-absorbable, UHMWPE (UHMWPE ≥ 88.0%) + Additive: Loctite 4014 (<12.0% in the Suture Button)) | SE Analysis 2 | He | Healthium Medtech Limited | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India www.healthiummedtech.com CIN: U03311KA1992PLC013831 | Page 4 of 10 | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" replaced by a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller font. T-Button® Adjustable Loop UHMWPE Suture PEEK Button Image /page/7/Picture/3 description: The image contains the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one blue, with a white plus sign where they intersect. | S. No | Parameters | Arthrex ACL TightRope® (K221128) (Primary Predicate) | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (Subject Device) | Comments | |-------|-----------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | 8. | Design Features | Arthrex ACL TightRope®: Image: Arthrex ACL TightRope | T-Button®A - Closed button preloaded with UHMWPE adjustable loop Image: Closed Button Image: Closed button preloaded with UHMWPE adjustable loop | SE Analysis 3 | | Healthium Medtech Limited | Page 5 of 10 | |-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India www.healthiummedtech.com CIN: U03311KA1992PLC013831 | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" being a red circle. Below the company name, the words "Arthroscopy Solutions" are written in a smaller, sans-serif font. T-Button® Adjustable Loop UHMWPE Suture PEEK Button | S. No | Parameters | Arthrex ACL TightRope® (K221128) (Primary Predicate) | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (Subject Device) | Comments | |-------|------------|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | | | | T-Button® S - Open button non preloaded with UHMWPE adjustable loop Image: Open Button Image: Suture Button and UHMWPE Adjustable Loop | | He | Healthium Medtech Limited | | |----------------------------------------------------------------------------------------------------|--------------| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India | Page 6 of 10 | | www.healthiummedtech.com CIN : U03311KA1992PLC013831 | | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" represented by a red circle. Below the company name, the words "Arthroscopy Solutions" are written in a smaller, lighter font. T-Button® Adjustable Loop UHMWPE Suture PEEK Button | S. No | Parameters | Arthrex ACL TightRope® (K221128) (Primary Predicate) | T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button & T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (Subject Device) | Comments | |-------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | 9. | Specifications and Dimensions | • ACL TightRope® RT, double- loaded passing sutures Button - 13mm x 3.3mm x1.5mm (Length x width x Height) Loop Length: 90 mm | • T-button A - Closed button: Button Dimension: 16mm x 7.5mm (Diameter x Height) Loop Length: 90 mm • T-button S - Open button: Button Dimension: 16mm x 7.5mm (Diameter x Height) Loop Length: 90 mm | SE Analysis 4 | | 10. | Single Use/Reuse | Single use | Single use | Similar as predicate device | | 11. | Shelf Life | 5 Years | 5 Years | Similar as predicate device | | 12. | Sterilization | ETO | ETO | Similar as predicate device | | 13. | Performance Data | • Ultimate load testing • Cyclic displacement | • Pull-Out Testing • Cyclic Loading | Similar as predicate device | | 14 | Safety Data | • Bacterial Endotoxin | • Skin Sensitization, • Intracutaneous reactivity • Material Mediated Pyrogenicity • Acute Systemic Toxicity • In vitro cytotoxicity • Bone Implantation studies • Intramuscular Implantation Study • Bacterial Endotoxin | - | Healthium Medtech Limited Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India Page 7 of 10 www.healthiummedtech.com | CIN : U03311KA1992PLC013831 {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font. Image /page/10/Picture/2 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one orange and one blue. The circles are divided into quadrants by a white cross. ### Substantial Analysis ### SE Analysis 1 Button Material The primary predicate Arthrex ACL TightRope® button is made of Titanium whereas the reference predicate ANCHORMAN Tibial Ligament Fixation Device material of construction is PEEK. The subject device material of construct for button is PEEK (Polyether Ether Ketone) which is equivalent to the reference predicate. The reference predicate has already proven safety and efficacy of PEEK material in reference to the titanium based button in their K170388 submission. PEEK is chemically inert and insoluble, has a modulus of elasticity closer to human cortical bone. Hence, PEEK represents a stable and biocompatible material that may address the issues that are present with titanium screws, such as graft damage because of material hardness and interference with imaging. PEEK has poor osseointegration. PEEK has excellent bio-compatibility and biological stability, and is a very favorable implant material. Also, the bio-compatibility testing of the subject devices has been performed to substantiate the biocompatible nature of the subject device. The summary of the biocompatibility testing performed has been shown in the below table. | Biocompatibility Test | Result | |------------------------------------------------------|-----------------------------------------| | Skin Sensitization (Guinea Pig Maximization Test) | Non-Sensitizer | | Intracutaneous Reactivity Test | Non-Reactive | | Material Mediated Pyrogenicity | Non-Pyrogenic | | Acute Systemic Toxicity Test | Did not Induce any Systemic Toxicity | | In vitro Cytotoxicity Test: Elution Method | Non-Cytotoxic | | Bone Implantation Studies (PEEK Rods) | Minimal or No Reaction | | Bone Implantation Studies (UHMWPE Suture) | Minimal or No Reaction | | Intra muscular Implant (PEEK) | Minimal or No Reaction | In reference to the above mentioned evidences the difference in the material of construction between the primary predicate and the subject device do not raise any new questions of safety and effectiveness. | Healthium Medtech Limited | | |----------------------------------------------------------------------------------------------------|--| | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India | | | www.healthiummedtech.com CIN : U03311KA1992PLC013831 | | | Page 8 of 10 | | {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "ArthroscopySolutions" in a smaller, sans-serif font. Image /page/11/Picture/3 description: The image shows the logo for Healthium. The word "Healthium" is written in a blue sans-serif font on the left side of the image. To the right of the word, there is a graphic consisting of two overlapping circles, one blue and one orange, with a white plus sign in the intersection. ### SE Analysis 2 Loop Material The adjustable loop material construct of the primary predicate device (Arthrex ACL TightRope®) and the adjustable loop of the T-button®A - Closed button (subject device) is UHMWPE; which are similar. However, the adjustable loop of the T-button® S - Open button (Subject Device) has Loop and Suture Button. The material of construct of loop is UHMWPE (UHMWPE 100.0%) and Suture Button has a material of construct of Non-absorbable, UHMWPE (UHMWPE ≥ 88.0%) + Additive: Loctite 4014 (≤12.0% in the Suture Button)). The suture button in the adjustable loop tends to hold the loop, the pull out strength of the suture button in the bench testing has been performed and evaluated, the results are perceptible to define the strength of suture button to hold the loop. The above mentioned addition of Suture Button in the adjustable loop of the T-button® S - Open button (Subject Device) has no impact on the safety and efficacy of the product. ### SE Analysis 3 Design Feature The Arthrex ACL TightRope® and the ANCHORMAN Tibial Ligament Fixation Device offers adjustable cortical fixation for cruciate ligament reconstruction. The ACL TightRope® RT comes with the regular button (13mm (L) x 3.3mm (W) x1.5mm (H)) preloaded with adjustable loop and double loaded passing sutures whereas the subject device comes with Open and Closed Button having dimensions (16mm(dia)x 7.5mm (H)). The Closed button is preloaded with UHMWPE adjustable loop and in Open Button the adjustable loop is non preloaded. The Pull Out Test and the Cyclical Load tests were performed for the primary predicate, reference predicate and the subject device and the results were compared and found equipotent in terms of safety and efficacy irrespective to the material of construction and design. ### SE Analysis 4 Specifications and Dimensions During the bench testing of subject device, it was observed that the changes in dimensions are not leading to any kind of new risks with the performance of subject device, and the acceptance criteria was met in each of the performance tests. By considering the performance data of the subject device, it is evident that the changes in dimensions are not causing and or does not affect the safety and efficacy of the product when comparing it with Predicate device. ### 1.7. Summary of Performance Data {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font. Image /page/12/Picture/2 description: The image contains the word "Healthium" in a bold, blue font. To the right of the word is a logo consisting of two overlapping circles. The top circle is orange, and the bottom circle is blue. Each circle has a white plus sign in the center. The T-Button® Adjustable Loop UHMWPE Suture PEEK Button, Primary Predicate device and Reference Predicate underwent tests to determine their pull-out strength, cyclical loading. Results demonstrated that the T-Button® Adjustable Loop UHMWPE Suture PEEK Button performs statistically equivalent to the predicate device and in addition to mechanical performance testing, biocompatibility testing, sterilization validation, shelf-life, pyrogenicity testing and endotoxin monitoring were also performed to support the demonstration of substantial equivalence. ### 1.8. Clinical Testing Not Applicable ### 1.9. Conclusion There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate devices Arthrex ACL TightRope® in Intended use, Indications for use, function, Sterilization method, Shelf Life, and operational principles. From the data available we can justify that the T-Button®Adjustable Loop UHMWPE Suture PEEK Button is as safe, and as effective and performs the same indications for use as that of already marketed predicate device identified.