(55 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes.
The device is used for reconstructive treatment of ruptured or damaged ligaments, which is a therapeutic purpose.
No
This device is an implantable medical device used for the reconstructive treatment of ruptured or damaged ligaments, not for diagnosis.
No
The device description clearly states it is a physical implant made of titanium alloy and PEEK, intended for surgical fixation. It is a hardware device, 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 Function: The Medacta Ligament Staple is a surgical implant used to physically fix soft tissue (ligaments) to bone within the body. It is a mechanical device used for reconstruction.
- Intended Use: The intended use clearly states it's for "reconstructive treatment of ruptured or damaged MCL and LCL," which is a surgical procedure.
- Device Description: The description details the materials and how it's impacted onto the bone, all related to its function as a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, based on the provided information, the Medacta Ligament Staple is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medacta Ligament Staple is intended for use in medial collateral ligament (MCL) and lateral collateral ligament (LCL) reconstruction.
Reconstructive treatment of ruptured or damaged MCL and LCL.
Product codes
JDR
Device Description
Medacta Ligament Staple is a single size (ø11 mm) extra cortical fixation device which is impacted on the Medial Collateral Ligament (MCL) or on the Lateral Ligament (LCL) for soft tissue to bone refixation by means of a dedicated impactor. The device consists of a circular plate with protruding tapered serrated legs, made of titanium alloy (Ti6A14V ELI according to ISO 5832-3 and ASTM F136), and a staple inlay, made of PEEK according to ASTM F2026, for pressing the graft down to the bone, featuring a lower spike patterned surface for increasing soft tissue fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Medial Collateral Ligament (MCL) and Lateral Ligament (LCL)
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
- DESIGN VALIDATION
- Ligament staple Porcine bone workshop, verifying the performance of the subject device
- Ligament staple wetlab, validating the subject device for the intended population and purpose
- CHARACTERIZATION TESTING
- Cyclic and load-to-failure properties of ligament staple device for soft tissue fixation
- Ligament staple MR safety evaluation and testing according to ASTM F2052-15, ASTM F2213-17, ASTM F2182-11a and ASTM F2119-07 (2013)
- 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 according to ISO 10993
- SHELF-LIFE testing according to ISO 11607-1 and ISO 11607-2
Clinical Studies: - No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arcus Staple System (K151160)
Reference Device(s)
A Richards Staple (pre-amendment device), A MectaScrew PEEK Interference Screw (K190892), A MectaLock Ti Suture Anchor (K191300)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
April 12, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis. Tennessee 83118
Re: K210456
Trade/Device Name: Ligament Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: February 12, 2021 Received: February 16, 2021
Dear Mr. 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 Mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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.
Pooja Panigrahi -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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210456
Device Name Ligament Staple
Indications for Use (Describe)
The Medacta Ligament Staple is intended for use in medial collateral ligament (MCL) and lateral ligament (LCL) reconstruction.
Reconstructive treatment of ruptured or damaged MCL and 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) |
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3
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 of Quality and Regulatory, Medacta USA Date Prepared: February 12, 2021 Date Revised: March 31, 2021
II. Device
| Device Proprietary Name: | Ligament Staple |
|---|---|
| Common or Usual Name: | Staple, fixation bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Primary Product Code: | JDR |
| Regulation Number: | 21 CFR 888.3030 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
-
Arcus Staple System (K151160), Nextremity Solution
In addition, the following Reference devices are cited within the submission: -
A Richards Staple (pre-amendment device), Smith and Nephew
-
A MectaScrew PEEK Interference Screw (K190892), Medacta International SA
-
A MectaLock Ti Suture Anchor (K191300), Medacta International SA
IV. Device Description
Medacta Ligament Staple is a single size (ø11 mm) extra cortical fixation device which is impacted on the Medial Collateral Ligament (MCL) or on the Lateral Ligament (LCL) for soft tissue to bone refixation by means of a dedicated impactor. The device consists of a circular plate with
4
protruding tapered serrated legs, made of titanium alloy (Ti6A14V ELI according to ISO 5832-3 and ASTM F136), and a staple inlay, made of PEEK according to ASTM F2026, for pressing the graft down to the bone, featuring a lower spike patterned surface for increasing soft tissue fixation.
V. Indications for Use
The Medacta Ligament Staple is intended for use in medial collateral ligament (MCL) and lateral collateral ligament (LCL) reconstruction.
Reconstructive treatment of ruptured or damaged MCL and LCL.
VI. Comparison of Technological Characteristics
The Ligament Staple and the predicate Arcus Stare the following characteristics:
- . staple material;
- biocompatibility;
- device usage;
- . sterility; and
- packaging.
The Ligament Staple differs from the predicate Arcus Staple as follow:
- . size: and
- design. .
Discussion
Medacta International SA has not made any change to the indication for use, material, device usage, biocompatibility, sterility and packaging of the subject device respect to the predicate device. The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject devices and supports the substantial equivalence of the Ligament Staple to the identified predicate devices.
VII. Performance Data
Based on the risk analysis, design validation and characterization testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION
- o Ligament staple Porcine bone workshop, verifying the performance of the subject device
- o Ligament staple wetlab, validating the subject device for the intended population and purpose
5
- CHARACTERIZATION TESTING ●
- 0 Cyclic and load-to-failure properties of ligament staple device for soft tissue fixation
- Ligament staple MR safety evaluation and testing according to ASTM F2052-15, ASTM o F2213-17, ASTM F2182-11a and ASTM F2119-07 (2013)
- . PYROGENICITY
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter >
- 0 Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- . BIOCOMPATIBILITY evaluation according to ISO 10993
- . SHELF-LIFE testing according to ISO 11607-1 and ISO 11607-2
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that the Ligament Staple is substantially equivalent to the identified predicate devices.