(85 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a suture anchor, with no mention of AI or ML capabilities.
Yes
The device is described as an implantable device specifically for tissue refixation within the shoulder joint (rotator cuff repair, biceps tenodesis), indicating a therapeutic purpose to repair or treat a condition.
No
Explanation: The device is described as an implantable suture anchor used for fixation of soft tissue to bone during surgical repairs (rotator cuff repair and biceps tenodesis). Its function is therapeutic, not diagnostic.
No
The device description explicitly states it is an implantable device composed of a titanium alloy anchor and preloaded sutures, provided with a disposable stainless steel driver. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of suture (soft tissue) to bone in shoulder" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as an "implantable device" composed of an anchor and sutures, used for "soft tissue refixation within the shoulder joint." This is a physical implant used to repair tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The MectaLock TI Triple Loaded Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure:
- Shoulder: rotator cuff repair and biceps tenodesis.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The MectaLock TI Triple Loaded Suture Anchors are implantable devices used for soft tissue refixation within the shoulder joint (rotator cuff repair, biceps tenodesis). They are composed of an anchoring component (Titanium alloy anchor) and preloaded with UHMWPE non-absorbable braided sutures.
This implantable assembly, is provided sterile and individually packaged, mounted on a dedicated disposable stainless steel driver with a plastic handle, allowing the surgeon to insert and place the MectaLock TI Triple Loaded Suture Anchor into the patient.
The MectaLock TI Triple Loaded Suture Anchor are available in 4 different configurations depending on anchor size (Ø5.0 or Ø6.5 mm) and typology of preloaded sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies
- PERFORMANCE TESTING
- MectaLock TI Triple Loaded Suture Anchor Design validation, cadaver lab
- MectaLock TI and MectaLock TI Triple Loaded Suture Anchor Substantial Equivalence Assessment
- MR safety evaluation
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY evaluation
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
February 24, 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.
Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K223582
Trade/Device Name: MectaLock TI Triple Loaded Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 23, 2022 Received: December 1, 2022
Dear Chris Lussier:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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
Laura C. Rose, 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
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Indications for Use
510(k) Number (if known)
Device Name
MectaLock TI Triple Loaded Suture Anchor
Indications for Use (Describe)
The MectaLock TI Triple Loaded Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure:
- Shoulder: rotator cuff repair and biceps tenodesis.
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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510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director, Quality, Regulatory, and Clinical Research, Medacta USA
Date Prepared: November 30, 2022 Date Revised: February 21, 2023
II. Device
| Device Proprietary Name: | MectaLock TI Triple Loaded Suture Anchor |
|---|---|
| Common or Usual Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Primary Product Code | MBI |
| Regulation Number: | 21 CFR 888.3040 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
- A MectaLock TI Suture Anchor, K191300, Medacta International SA
IV. Device Description
The MectaLock TI Triple Loaded Suture Anchor is a line extension to the MectaLock TI Suture Anchor cleared within K191300.
The MectaLock TI Triple Loaded Suture Anchors are implantable devices used for soft tissue refixation within the shoulder joint (rotator cuff repair, biceps tenodesis). They are composed of an anchoring component (Titanium alloy anchor) and preloaded with UHMWPE non-absorbable braided sutures.
This implantable assembly, is provided sterile and individually packaged, mounted on a dedicated disposable stainless steel driver with a plastic handle, allowing the surgeon to insert and place the MectaLock TI Triple Loaded Suture Anchor into the patient.
4
The MectaLock TI Triple Loaded Suture Anchor are available in 4 different configurations depending on anchor size (Ø5.0 or Ø6.5 mm) and typology of preloaded sutures.
Indications for Use V.
The MectaLock TI Triple Loaded Suture Anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in shoulder in the following procedure:
- Shoulder: rotator cuff repair and biceps tenodesis. ●
VI. Comparison of Technological Characteristics
The subject devices are substantially equivalent to the predicate, MectaLock TI Suture Anchor (K191300), with regards to the following characteristics:
- indications for use; ●
- anchor diameters: ●
- anchor tip and thread shape; ●
- materials;
- biocompatibility;
- device usage;
- sterilization;
- shelf-life; and
- packaging. ●
The subject devices differ respect to the predicate, MectaLock TI Suture Anchor (K191300), with regards to the following characteristics:
- anchors length:
- anchor eyelet and driver connection; ●
- preloaded suture; and ●
- driver design. ●
Discussion
The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness.
Medacta International SA has not made any change to the indications for use, anchor diameters, anchor external design, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.
Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the MectaLock TI Triple Loaded Anchors to the identified predicate device.
Performance Data VII.
Based on the risk analysis, performance testing was conducted to written protocols. The following tests and rationales are provided in support of the substantial equivalence determination:
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Non-Clinical Studies
- PERFORMANCE TESTING ●
- MectaLock TI Triple Loaded Suture Anchor Design validation, cadaver lab o
- MectaLock TI and MectaLock TI Triple Loaded Suture Anchor Substantial Equivalence O Assessment
- MR safety evaluation O
- PYROGENICITY ●
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is O equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination о
- The subject devices are not labeled as non-pyrogenic or pyrogen free. o
- BIOCOMPATIBILITY evaluation ●
- SHELF-LIFE evaluation ●
Clinical Studies:
- No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that the MectaLock TI Triple Loaded Suture Anchors are substantially equivalent to the predicate devices.