(272 days)
Not Found
No
The 510(k) summary describes a mechanical implant and delivery system for meniscus repair. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical properties like pull-out strength and cyclical loading.
Yes
The device is used for meniscus repair, which is a therapeutic intervention aimed at restoring or improving physiological function.
No
The device description indicates that the SURESTITCH™ is an implant used for meniscal repair, which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is an "all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures" and mentions an "adjustable depth control knob" and "various needle curvature," indicating it is a physical implant and delivery system, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is a surgical implant used within the body to repair a meniscus. It's a physical device used for mechanical repair, not for testing biological samples.
- Intended Use: The intended use is for "percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair." This describes a surgical procedure, not a diagnostic test.
The information provided clearly indicates this is a surgical implant used for repair, not a device for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.
Product codes
MBI
Device Description
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Meniscus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and Predicate device underwent tests to determine their pull-out strength and cyclical loading. Results demonstrated that the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant performs statistically equivalent to the predicate device FAST-FIX 360 meniscal repair system.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
December 28, 2023
Image /page/0/Picture/1 description: The image contains 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 Deputy General Manager Regulatory Affair 472-D. 13th Cross. 4th Phase Peenva Industrial Area Bangalore, Karnataka 560058 India
Re: K230891
Trade/Device Name: SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 28, 2023 Received: November 28, 2023
Dear Pankaj 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.
Sara S. Thompson -S
For
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230891
Device Name
SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant
Indications for Use (Describe)
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/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/1 description: The image contains the text "K230891" in the upper left corner. Below the text is the word "Healthium" in a bold, blue 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 middle.
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. |
| Contact Person | PANKAJ DAWAR |
| Phone: | + 91-80-41868000 |
| E-mail: | pankaj.d@healthiummedtech.com |
| Date Prepared: | 27-12-2023 |
1.2. Device Identification:
| Device Trade Name: | SURESTITCH™ UHMWPE Suture PEEK Button
Meniscus Repair Implant |
|----------------------|------------------------------------------------------------------|
| Device Common Name: | Non-Absorbable Suture Retention Device |
| Classification Name: | Nonabsorbable poly (ethylene terephthalate) surgical
Suture |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | MBI |
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Image /page/5/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The logo consists of the word "SIRONIX" 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/5/Picture/1 description: The image contains the text "K230891" at the top left. Below the text is the word "Healthium" in a stylized font. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape dividing them into quadrants.
1.3. Predicate Devices:
| Device Name | 510(k) Number |
|---|---|
| Smith & Nephew FAST-FIX 360 Meniscal | |
| Repair System | K121861 |
Table 1 – List of Predicate Device
1.4. Device Description
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.
Intended Use & Indications for Use 1.5.
Intended Use
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as, meniscal repair.
Indications for Use
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.
Comparison of Technological Characteristics 1.6.
The fundamental scientific technology, materials of construction and mechamism of operation are similar between the subject device SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and the predicate device. Table 2 summarizes the comparison of technological characteristics between the subject and predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for Sironix. The logo has the word "SIRONIX" in bold, sans-serif font. The "O" in "SIRONIX" is red, while the rest of the letters are black. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/6/Picture/1 description: The image contains the alphanumeric string "K230891" in bold, black font at the top left. Below this is the word "Healthium" in a bold, blue font. To the right of the word is a logo consisting of a blue circle with a white cross inside, partially overlapping an orange circle.
| Sl.
No | Parameters | Smith & Nephew FAST-FIX
360 Meniscal Repair System
(K121861) | SURESTITCH™ UHMWPE
Suture PEEK Button
Meniscus Repair Implant
(Subject device) |
|-----------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Manufacturer | Smith & Nephew, Inc | Healthium Medtech Limited |
| 2. | Product Code | GAT | MBI |
| 3. | Regulation
Number | 21 CFR 878.5000 | 21 CFR 888.3040 |
| 4. | Classification | Class II | Class II |
| 5. | Intended Use | The FAST-FIX 360 Meniscal
Repair System is intended for use
as a suture retention device to
facilitate percutaneous or
endoscopic soft tissue procedures.
The FAST-FIX 360 System is
indicated for use in meniscal repairs
and allograft transplant procedures.
The FAST-FIX 360 System is
intended to be used for anchoring
the allograft to the meniscal rim
during allograft transplant
procedures. | The SURESTITCH™ UHMWPE
Suture PEEK Button Meniscus
Repair Implant is intended for use
as a suture retention device to
facilitate percutaneous or
endoscopic soft tissue procedures
such as, meniscal repair. |
| 6. | Material
of
Construction | Implant - PEEK
Suture-UHMWPE with
monofilament Polypropylene | Implant - PEEK
Suture- UHMWPE |
| 7. | Design
Feature | 2-peek implants pretied with non-
absorbable suture | 2-peek implants pretied with non-
absorbable suture |
| 8. | Specifications
and
Dimensions | Implant 1:
5.00 mm X 0.95 mm (LXD)
Implant 2:
4.8mmX1.4mmX0.8mm
(LXWXH)
Delivery Needle: Straight or
Curved
Suture Size - USP #2-0 | Implant 1:
5.50 mm X 0.95 mm (L X D),
Implant 2:
6.4(max) mm X 0.95 mm (L X D),
Delivery Needle: LEFT, RIGHT,
UP, DOWN
Suture Size - USP #3-0
Implant 01 XL:
5.50 mm X 1.2 mm (L X D),
Implant 02 XL:
6.4(max) mm X 1.2 mm (L X D)
Delivery Needle: LEFT, RIGHT,
UP, DOWN
Suture Size - USP #2-0 |
| SI.
No | Parameters | Smith & Nephew FAST-FIX
360 Meniscal Repair System
(K121861) | SURESTITCH™ UHMWPE
Suture PEEK Button
Meniscus Repair Implant
(Subject device) |
| 9. | Shelf Life | 3 Years | 5 Years |
| 10. | Sterilization
Method | EtO | EtO |
| 11. | Performance
Data | Pull-out strength,
Cyclical loading | Pull-out strength,
Cyclical loading |
| 12. | Safety Data | No data available | • Skin Sensitization
• Intracutaneous reactivity
• Material Mediated Pyrogenicity
• Acute Systemic Toxicity
• In vitro cytotoxicity
• Bone Implantation
• Muscle Implantation
• Bacterial Endotoxin |
Table 2 – Substantial Equivalence Table
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Image /page/7/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/7/Picture/2 description: The image contains the text "K230891" in the upper left corner. Below this text is the word "Healthium" in a bold, sans-serif font. To the right of the text is a logo consisting of two overlapping circles, one blue and one orange.
8
Image /page/8/Picture/0 description: The image shows the logo for Sironix. The logo has the word "SIRONIX" in bold, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "Arthroscopy Solutions".
Image /page/8/Picture/1 description: The image contains the alphanumeric string "K230891" in the upper left corner. Below the alphanumeric string is the word "Healthium" in a bold, sans-serif font. To the right of the word is a logo consisting of a blue circle with a white cross in the center, partially overlapping an orange circle.
Summary of Performance Data 1.7.
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and Predicate device underwent tests to determine their pull-out strength and cyclical loading. Results demonstrated that the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant performs statistically equivalent to the predicate device FAST-FIX 360 meniscal repair system.
1.8. Non-Clinical Testing
The Static pull out testing and cyclic loading were performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.
Bacterial endotoxin per USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling.
1.9. Conclusion
The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is substantially equivalent to the predicate devices. Any differences between the subject device and the predicate devices do not raise 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.