Who is the manufacturer of INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

Healthium Medtech Limited filed the 510(k) submission for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (K232886).

What is the FDA product code for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

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

What is the regulatory pathway for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

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

What are the predicate devices for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

Conmed Linvatec XO Button™ (Continous Loop) (K070780); RIGIDLOOPTM Cortical Fixation System (K130814).

Who can help prepare an FDA 510(k) submission like INFILOOP® Fixed Loop UHMWPE Suture Titanium 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.

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

K232886 · Healthium Medtech Limited · MBI · Nov 8, 2023 · Orthopedic

Device Facts

Record ID	K232886
Device Name	INFILOOP® Fixed Loop UHMWPE Suture Titanium Button
Applicant	Healthium Medtech Limited
Product Code	MBI · Orthopedic
Decision Date	Nov 8, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL).

Device Story

Device consists of titanium button and UHMWPE suture loop; used for soft tissue-to-bone fixation during arthroscopic knee ligament reconstruction (ACL, PCL, MCL, LCL). Surgeon inserts device to secure tendons/ligaments to bone. Provides mechanical fixation; replaces need for traditional fasteners. Benefits include accurate fixation and compatibility with arthroscopic approaches. Performance verified via pull-out and cyclic loading tests.

Clinical Evidence

Bench testing only. Included biocompatibility (sensitization, reactivity, pyrogenicity, systemic toxicity, cytotoxicity, implantation), sterility, shelf-life, pull-out testing, and cyclic loading. Literature review supported the use of pure UHMWPE suture material over polyester-blended sutures.

Technological Characteristics

Materials: Titanium button, UHMWPE suture loop. Single-use, sterile (ETO). Dimensions/specs within range of predicates. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for soft tissue-to-bone fixation in orthopedic reconstruction procedures, specifically knee ligament reconstruction (ACL, PCL, MCL, LCL).

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

Conmed Linvatec XO Button™ (Continous Loop) (K070780)
RIGIDLOOPTM Cortical Fixation System (K130814)

Related Devices

K221128 — Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II · Arthrex, Inc. · Oct 5, 2022
K233552 — IDEAL Ziploop · Riverpoint Medical · Nov 30, 2023
K970316 — INNOVASIVE 8MM LIGAMENT FASTENER · Innovasive Devices, Inc. · Apr 16, 1997
K260405 — FiberTape Button · Arthrex, Inc. · Mar 9, 2026
K202291 — Button Loop · Yunyi (Beijing) Medical Device Co., Ltd. · Jan 8, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ November 8, 2023 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. 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: K232886 Trade/Device Name: INFILOOP® Fixed Loop UHMWPE Suture Titanium Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 13, 2023 Received: September 18, 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Digitally signed by Jesse Muir -S 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232886 #### Device Name INFILOOP® Fixed Loop UHMWPE Suture Titanium Button Indications for Use (Describe) The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL). | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in large, bold, sans-serif letters, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font. The logo is simple and modern, and the red circle adds a pop of color. 510(k) Summary INFILOOP® Fixed Loop UHMWPE Suture Titanium Button Image /page/4/Picture/2 description: The image contains the alphanumeric string "K232886" in the upper left corner. Below this is the word "Healthium" in a stylized font. To the right of the word is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape in the center. ## 510(k) Summary based on the 21 CFR 807.92 | Date Prepared | 12 September 2023 | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K232886 | | Submitter | Healthium Medtech Limited 472-D, 13th Cross, 4th Phase, Peenya Industrial Area, Bangalore, India, 560058 Ph: +91 - 80 - 41868000 | | Contact Person | Pankaj Dawar Deputy General Manager Regulatory Affairs Ph: +91 - 80 - 41868000 pankaj.d@healthiummedtech.com | | Name of Device | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | | Common Name | Fixed Loop UHMWPE Suture Titanium Button | | Product Code | MBI | | Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Regulatory Class | II | | Predicate Device | Conmed Linvatec XO Button™ (Continous Loop) (K070780)-Primary Predicate RIGIDLOOPTM Cortical Fixation System (K130814)-Additional Predicate | | Reference Device | No reference device used | | Purpose of Submission | Traditional 510(k) is submitted to obtain clearance for the INFILOOP® Fixed Loop UHMPWE suture Titanium Button | | Device Description | The use of the INFILOOP® Fixed Loop UHMWPE Suture Titanium Button provides the orthopaedic surgeon a means of accurate fixation in ligament reconstructive surgery of soft tissue to bone fixation. The fixation device allows for arthroscopic ligament reconstruction approaches. | | Intended Use/Indications for Use | The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL) | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sironix. The logo consists of the word "SIRONIX" in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "Arthroscopy Solutions" in a smaller font. Image /page/5/Picture/2 description: The image contains the text "K232886" at the top left corner. Below the text is a logo for a company called "Healthium". The logo consists of the company name in a stylized font and a circular graphic with a cross shape in the middle. Page 2 of 4 ## Comparison of the Technological Characteristics with Predicate Device | S. No | Parameters | Conmed Linvatec XO Button™ (Continous Loop) (K070780) (Primary Predicate) | RIGIDLOOP™ Cortical Fixation System (K130814) (Additional Predicate) | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (Subject Device) | Comments | |----------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | 1. | Manufacturer | ConMed Linvatec | Medos International SARL | Healthium Medtech Limited | - | | 2. | Product Code | MBI (Classification Product Code) GAT (Subsequent Product Code) | MBI | MBI | Similar to predicate device | | 3. | Regulation Number | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 | Similar to predicate device | | 4. | Classification | Class II | Class II | Class II | Similar to predicate device | | 5. | Intended Use/ Indications for Use | The Conmed Linvatec XO Button™ with continuos loop is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or reconstruction of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament. | The RIGIDLOOP™ Cortical Fixation System is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair | The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is indicated in surgical procedures for soft tissue fixation to the bone. It is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as Knee ligament reconstruction which includes anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), and lateral collateral ligament (LCL). | Similar to predicate device | | 6. | Button and Loop Material | Button: Titanium Loop: UHMWPE | Button: Titanium Loop: UHMWPE | Button: Titanium Loop: UHMWPE | Similar to predicate device | | S. No | Parameters | Conmed Linvatec XO Button™ (Continous Loop) (K070780) (Primary Predicate) | RIGIDLOOP™ Cortical Fixation System (K130814) (Additional Predicate) | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button (Subject Device) | Comments | | 7. | Suture Material | Polyester, USP#5 UHMWPE, USP#3-4 | UHMWPE, USP#5 Polyester, USP#5 | UHMWPE, USP#5 UHMWPE, USP#5 | Refer the SE Analysis | | 8. | Single Use/Reuse | Single Use | Single Use | Single Use | Similar to predicate device | | 9. | Shelf Life | 5 Years | 5 Years | 5 Years | Similar to predicate device | | 10. | Sterilization Method | ETO | ETO | ETO | Similar to predicate device | | 11. | Performance Data | Pull Out Testing Cyclical Loading | Pull Out Testing | Pull Out Testing Cyclical Loading | Similar to predicate device | | 12. | Safety Data | No Data Available | No Data Available | Skin Sensitization Intracutaneous reactivity Material Mediated Pyrogenicity Acute Systemic Toxicity In-vitro cytotoxicity Bone Implantation Intramuscular Implantation Bacterial Endotoxin USP <85> MRI Compatibility | - | Registered Office: 472/D, 13th Cross, 4th Phase, Peenya Industrial Area, Bengaluru – 560058, India www.healthiummedtech.com | CIN : U03311KA1992PLC013831 {6}------------------------------------------------ 510(k) Summary INFILOOP® Fixed Loop UHMWPE Suture Titanium Button Image /page/6/Picture/1 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. The logo is simple and modern, and the red circle adds a pop of color. Image /page/6/Picture/2 description: The image contains the text 'K232886' in the upper left corner. Below this text is the word 'Healthium' in a stylized font. To the right of 'Healthium' is a logo consisting of a blue circle with a white cross inside, partially obscured by an orange circle with a white cross inside. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Healthium, a medical device company. The logo consists of the word "Healthium" in a blue, sans-serif font, with a stylized graphic to the right. The graphic is composed of two overlapping circles, one orange and one blue, with a white cross shape in the center where they intersect. The text "K232886" is located in the upper left corner of the image. ## SE Analysis Predicate devices are preloaded with one UHMWPE suture and one Polyester Suture, whereas the subject device is preloaded with UHMWPE sutures. From the literature study, it can be inferred that the Polyester suture had lower ultimate load than all groups of sutures used in the study except the suture composed of polyester and UHMWPE (P<. 05). Pure UHMWPE suture had higher ultimate failure load than sutures composed of either polyester or polyester plus UHMWPE (P<.05). Predominant failure mode was suture cutting through the meniscus for the groups except for polyester suture which failed by suture rupture. This literature study shows that Pure UHMWPE material has better ultimate load than the material used in predicate and this change is not raising any questions on the safety and efficacy of the subject device. ### Comparison and summary of the technological characteristics The proposed INFILOOP® Fixed Loon UHMWPE Suture Titanium Button (referred to as the "subjected device") shares similar basic design features and materials of construction for the button and loop when compared to the predicate devices. The specifications and dimensions of the subjected device fall within the range of those of the predicate devices. Minor differences in technological characteristics do not raise any safety or effectiveness concerns. ### Comparison and summary of the safety, performance and non-clinical testing data Verification activities were performed on the implant and its predicates. Testing assessments included biocompatibility, pyrogenicity (both material andotoxin) in accordance with USP <85>, sterility, shelf life, pull-out testing, and cyclic loading (as mentioned in the comparison table). The results of performance testing have demonstrated that the proposed devices are suitable for their intended use. ## Conclusion The INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is substantially equivalent to the predicate devices. Any differences between the subject device and the predicate devices do not raised questions concerning safety and effectiveness. Based on the indications for use, technological characteristics, and the summary of data submitted, it is determined that the proposed device is substantially equivalent to the currently marketed predicate devices.