(143 days)
No
The summary describes a system of implantable devices for ligament reconstruction and fixation, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The device is used for reconstructive treatment of ruptured anterior and posterior cruciate ligaments, which is a therapeutic purpose.
No
The device is described as an implantable system for the reconstructive treatment of ligament ruptures and graft fixation. It does not perform diagnostic functions.
No
The device description explicitly states that the components are "implantable devices" and are "manufactured with Titanium-6 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI)," indicating they are physical hardware components, 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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The M-ARS ACL: Anatomic Ribbon Surgery System is described as an implantable device used for the reconstructive treatment of ligament ruptures and the fixation of a graft during surgery.
- Intended Use: The intended use is for the reconstructive treatment of ruptured ligaments and the fixation of grafts. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant used in vivo (within the living body) to physically repair and stabilize ligaments. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
M-ARS ACL: Anatomic Ribbon Surgery System - M-ARS ACL Tibial Pull Suture Plate (PSP): Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
M-ARS ACL: Anatomic Ribbon Surgery System: M-ARS ACL Extracortical Femoral Button: Reconstructive therapy of ruptures to the anterior cruciate ligament by means of autologous grafts.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The M-ARS ACL: Anatomic Ribbon Surgery System components are implantable devices used for the reconstructive treatment of ligament ruptures as well as the fixation of an implanted Anterior Cruciate Ligament graft by means of suspensory extracortical fixation.
The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button component is an implantable extracortical suspension device used to secure the graft fixation on the femoral side during ACL reconstruction surgery. The M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate (PSP) component is an implantable extracortical suspension device used to secure the graft fixation on the tibial side during ACL reconstruction surgery.
The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-6 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 comparison: geometrical and comparative analysis between the M-ARS ACL: Anatomic Ribbon Surgery System and the predicate devices to show mechanical equivalence:
- Cadaver workshop: surgeon evaluations to verify the design features and surgical technique: and
- substantial equivalence evaluation: a comparative analysis between the M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate and the predicate device.
Pyrogenicity: - Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination.
- Medacta does not intend to label the subject devices as non-pyrogenic or pyrogen free.
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.
K132878, K141988, K153664, K162061
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Medacta International SA % Ms. Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
October 23, 2017
Re: K171640
Trade/Device Name: M-ARS ACL: Anatomic Ribbon Surgery System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 11, 2017 Received: September 12, 2017
Dear Ms. Rose:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171640
Device Name
M-ARS ACL: Anatomic Ribbon Surgery System
Indications for Use (Describe)
M-ARS ACL: Anatomic Ribbon Surgery System - M-ARS ACL Tibial Pull Suture Plate (PSP): Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
M-ARS ACL: Anatomic Ribbon Surgery System: M-ARS ACL Extracortical Femoral Button: Reconstructive therapy of ruptures to the anterior cruciate ligament by means of autologous grafts.
| 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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3.0 510(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 Affairs Manager Date Prepared: June 01, 2017 Date Revised: October 17, 2017
II. Device
| Device Proprietary Name: | M-ARS ACL: Anatomic Ribbon Surgery System |
|---|---|
| Common or Usual Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Primary Product Code: | MBI |
| Regulation Number: | 21 CFR 888.3040 |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- KSEA Flipptack, K982571, Karl Storz Endoscopy - America, Inc. (also referred to as Karl Storz's Flipptack)
- . Endotack, K022853, Karl Storz Endoscopy - America, Inc.
The following reference devices are cited within the submission:
- M.U.S.T. Extension, K132878, Medacta International SA ●
- M.U.S.T. Pedicle Screw System, K141988, Medacta International SA
- M.U.S.T. Pedicle Screw System, K153664, Medacta International SA
- M.U.S.T. Pedicle Screw System, K162061, Medacta International SA
IV. Device Description
The purpose of this submission is to gain clearance for the M-ARS ACL: Anatomic Ribbon Surgery System. The M-ARS ACL: Anatomic Ribbon Surgery System components are implantable devices used for the reconstructive treatment of ligament ruptures as well as the fixation of an implanted Anterior Cruciate Ligament graft by means of suspensory extracortical fixation.
4
The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button component is an implantable extracortical suspension device used to secure the graft fixation on the femoral side during ACL reconstruction surgery. The M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate (PSP) component is an implantable extracortical suspension device used to secure the graft fixation on the tibial side during ACL reconstruction surgery.
The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-6 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI).
V. Indications for Use
M-ARS ACL Extracortical Femoral Button
Reconstructive therapy of ruptures to the anterior and posterior cruciate ligament by means of autologous grafts.
M-ARS ACL Tibial Pull Suture Plate (PSP)
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
Comparison of Technological Characteristics VI.
The M-ARS ACL: Anatomic Ribbon Surgery System and the predicate devices share the following characteristics:
- Material;
- Sterile: ●
- device usage; and ●
- Extracortical Fixation Button; ●
- . length;
- . width:
- . thickness;
- number and purpose of holes; and .
- . critical section thickness.
The M-ARS ACL: Anatomic Ribbon Surgery System is technologically different from the predicate devices as follows:
- Tibial Pull Suture Plate, and
- length;
- . width:
- thickness; ●
- number and purpose of holes; ●
- . geometry; and
- . critical section dimensions
- Extracortical Fixation Button ●
- . critical section width.
5
The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-4 Vanadium Extra Low Interstitial Alloy according to ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy and ASTM F136-13 Standard Specification For Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy For Surgical Implant Applications.
This material, used with Karl Storz's Flipptack (K982571) and Karl Storz's Endotack (K022853), has an extensive biocompatibility history and has been previously reviewed by FDA.
Due to the extensive history of use in currently marketed medical devices, additional biocompatibility testing was deemed unnecessary for the M-ARS ACL: Anatomic Ribbon Surgery System components. In addition, manufacturing processes for the subject devices are identical or similar to the reference devices the M.U.S.T. Pedicle Screw Systems (K162061, K153664, K141988, and K132878).
The tables below compare key technological features between the subject and predicate devices.
| Parameters | M-ARS ACL: Anatomic Ribbon
Surgery System Extracortical
Fixation Button
(Subject Device) | Karl Storz's Flipptack
K982571
(Predicate Device) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium Alloy (ELI) | Titanium Alloy |
| Length | 12.3 mm | 12.3 mm |
| Width | 4 mm | 4 mm |
| Thickness | 1.5 mm | 1.5 mm |
| Holes | 2 for suture loop for graft fixation
1 lateral hole for suture used to flip
implant
1 lateral hole for suture used to
pull construct | 2 for suture loop for graft fixation
1 lateral hole for suture used to flip
implant
1 lateral hole for suture used to pull
construct |
| Critical Section
Dimensions | Thickness: 1.5 mm
Width: 1.7 mm | Thickness: 1.5 mm
Width: 1.3 mm |
| Device Usage | Single Use | Single Use |
| Biocompatibility | Implant with permanent > 30 day | Implant with permanent > 30 day |
| Sterilization | Sterile | Sterile |
Technological comparison
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| Parameters | M-ARS ACL: Anatomic Ribbon
Surgery System Tibial Pull
Suture Plate
(Subject Device) | Karl Storz's Endotack
K022853
(Predicate Device) |
|------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Material | Titanium Alloy (ELI) | Titanium Alloy |
| Length | 20 mm | 16 mm |
| Width | 13 mm | 10 mm |
| Thickness | 1.2 mm | 2 mm |
| Holes | 2 central holes for adjustable suture
loop
2 lateral holes for additional
sutures, graft fixation and tension | 2 holes used for graft fixation and
tension |
| Geometry | C-Shape | Round Shape |
| Critical Section | Thickness: 2 mm | Thickness: 3 mm |
| Dimensions | Width: 2.84 mm | Width: 2 mm |
| Device Usage | Single Use | Single Use |
| Biocompatibility | Implant with permanent > 30 day | Implant with permanent > 30 day |
| Sterilization | Sterile | Sterile |
Discussion
As seen above, the technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. The M-ARS ACL: Anatomic Ribbon Surgery System is the same or similar to the predicate devices in terms of materials of construction, device usage, and sterility. Although there are some differences in the design attributes of the Tibial Pull Suture Plate, the intended use and functionality of the component are the same. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the M-ARS ACL: Anatomic Ribbon Surgery System to the identified predicate devices.
VII. Performance Data
Risks were identified based on the proposed design and testing was conducted to mitigate those risks. Based on the risk analysis, the following studies were performed in support of a substantial equivalence determination:
Non-Clinical Studies
- . design comparison: geometrical and comparative analysis between the M-ARS ACL: Anatomic Ribbon Surgery System and the predicate devices to show mechanical equivalence:
- . cadaver workshop: surgeon evaluations to verify the design features and surgical technique: and
- substantial equivalence evaluation: a comparative analysis between the M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate and the predicate device.
7
Pyrogenicity
- Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European . Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination.
- Medacta does not intend to label the subject devices as non-pyrogenic or pyrogen free. ●
Clinical Studies
- No clinical studies were conducted ●
VIII. Conclusion
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics as well as performance evaluations. The M-ARS ACL: Anatomic Ribbon Surgery System is as safe and effective as the predicate devices, Karl Storz's Flipptack (K982571) and Karl Storz's Endotack (K022853).