(87 days)
No
The device description and intended use clearly define a physical implant (cement restrictor) made of UHMWPE and stainless steel. There is no mention of software, algorithms, data processing, or any other component that would suggest the use of AI or ML. The performance studies focus on mechanical properties and biocompatibility, not algorithmic performance.
No
The device is an intramedullary cement restrictor used during hip arthroplasty to prevent cement from flowing down the diaphysis and facilitate cement pressurization. It does not directly treat a disease or condition; rather, it is a surgical aid.
No
The device is an intramedullary cement restrictor used during hip arthroplasty to prevent cement from flowing down the canal and to facilitate cement pressurization. Its function is mechanical and surgical, not diagnostic.
No
The device is described as a physical intramedullary cement restrictor made of UHMWPE and stainless steel wire, which are hardware components.
Based on the provided information, the MectaPlug PE II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to seal the intramedullary canal during hip arthroplasty surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant made of UHMWPE and stainless steel, designed to be placed inside the bone.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The MectaPlug PE II does not perform any such diagnostic function. It is a surgical tool/implant.
- Anatomical Site: The device is used within the intramedullary canal, which is an internal anatomical site. IVD tests are performed on samples taken from the body.
Therefore, the MectaPlug PE II is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MectaPlug PE II is an intramedullary cement restrictor, designed to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty, for primary or revision surgery.
Total hip arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
Partial hip arthroplasty is indicated in the following cases:
- Acute traumatic fracture of the femoral head or neck
- Non-union of femoral neck fracture
- Avascular necrosis of the femoral head
- Primary pathology involving the femoral head, but with a non-deformed acetabulum
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
MectaPlug PE II is an intramedullary cement restrictor (plug), used to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty. MectaPlug PE II prevents the cement from flowing down the diaphysis, thereby facilitating cement pressurization, MectaPlug PE II is composed of UHMWPE (ISO 5834-2) with a radiopaque stainless steel wire (ISO 5832-1).
MectaPlug PE II is positioned distal to the stem tip preventing cement from being displaced distally in the canal and increasing the intramedullary pressure at the bone-cement interface during insertion of the stem. A radio marker is included in the tip of the Medacta cement restrictor.
MectaPlug PE II has 6 discs divided in several leaves by oblique cuts and a central peg. The MectaPlug PE II device is available in the following sizes: S (Ø 8 to Ø 11), M (Ø 12 to Ø 15), L (Ø 16 to Ø 20), XL (Ø 21 to Ø 25), XXL (Ø 26 to Ø 30).
MectaPlug PE II is made in UHMWPE according to ISO 5834-2 Implants for surgery -- Ultrahigh-molecular-weight polyethylene Moulded forms and with a radiopaque wire in AISI 316LVM according to ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel.
Mectaplug PE II implants are provided sterile and in single-use packages.
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:
- Risk that the cement restrictors are inadequate for femoral canal shape and not suitable for AMIS approach, Design Validation Report Nr: B1 and Design Validation Report Nr: B3
- Risk that Product range is not adequate to cover all the intended population, Design Validation Report Nr: B1
- Risk of breakage of highly stressed parts, Design Validation Report Nr: B2
- Shelf Life Characterization of Medacta's Highly Crosslinked UHMWPE, Test Report
- Pyrogenicity
- Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- the subject devices are not labeled 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.
K800144, K791125, K192827, K131310
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
April 8, 2021
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 SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 83118
Re: K210062
Trade/Device Name: Mectaplug PE II Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: JDK Dated: January 8, 2021 Received: January 11, 2021
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 mav, 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 (0S) 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,
Vesa Vuniqi -S
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty 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) K210062
Device Name Mectaplug PE II
Indications for Use (Describe)
MectaPlug PE II is an intramedullary cement restrictor, designed to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty, for primary or revision surgery.
Total hip arthroplasty is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congental hip dysplasia
- · Avascular necrosis of the femoral head
- · Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, internal fixation, arthroplasty, hip resurfacing replacement or total hip arthroplasty
Partial hip arthroplasty is indicated in the following cases:
- · Acute traumatic fracture of the femoral head or neck
- · Non-union of femoral neck fracture
- · Avascular necrosis of the femoral head
- · Primary pathology involving the femoral head, but with a non-deformed acetabulum
| 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
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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: January 8, 2021 Date Revised: April 8, 2021
II. Device
| Device Proprietary Name: | Mectaplug PE II |
|---|---|
| Common or Usual Name: | Prosthesis, Hip, Cement Restrictor |
| Classification Name: | Surgical Mesh |
| Primary Product Code: | JDK |
| Regulation Number: | 21 CFR 878.3300 |
| Device Classification | II |
III. Predicate Device
Primary predicate device:
-
Tecres Cement Restrictors, K021765, Tecres S.p.A. .
Reference predicate: -
Femoral Cement Restrictors, K800144, Biomet Inc. ●
-
BUCK cement restrictors, K791125, Smith & Nephew .
-
Quadra P, K192827, Medacta International ●
-
GMK Full PE Tibial components, K131310, Medacta International SA .
Device Description IV.
MectaPlug PE II is an intramedullary cement restrictor (plug), used to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty. MectaPlug PE II prevents the cement from flowing down the diaphysis, thereby facilitating cement pressurization, MectaPlug PE II is composed of UHMWPE (ISO 5834-2) with a radiopaque stainless steel wire (ISO 5832-1).
4
MectaPlug PE II is positioned distal to the stem tip preventing cement from being displaced distally in the canal and increasing the intramedullary pressure at the bone-cement interface during insertion of the stem. A radio marker is included in the tip of the Medacta cement restrictor.
MectaPlug PE II has 6 discs divided in several leaves by oblique cuts and a central peg. The MectaPlug PE II device is available in the following sizes: S (Ø 8 to Ø 11), M (Ø 12 to Ø 15), L (Ø 16 to Ø 20), XL (Ø 21 to Ø 25), XXL (Ø 26 to Ø 30).
MectaPlug PE II is made in UHMWPE according to ISO 5834-2 Implants for surgery -- Ultrahigh-molecular-weight polyethylene Moulded forms and with a radiopaque wire in AISI 316LVM according to ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel.
Mectaplug PE II implants are provided sterile and in single-use packages.
V. Indications for Use
MectaPlug PE II is an intramedullary cement restrictor, designed to seal the intramedullary canal prior to cementation in total or partial hip arthroplasty, for primary or revision surgery.
Total hip arthroplasty is indicated in the following cases:
- Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, . rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head .
- Acute traumatic fracture of the femoral head or neck .
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial . hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
Partial hip arthroplasty is indicated in the following cases:
- . Acute traumatic fracture of the femoral head or neck
- . Non-union of femoral neck fracture
- Avascular necrosis of the femoral head .
- . Primary pathology involving the femoral head, but with a non-deformed acetabulum
VI. Comparison of Technological Characteristics
The subject device and the predicate device share the following characteristics:
- . shape;
- dimension: ●
- material of construction (UHMWPE) .
5
The subject device is technologically different from the predicate device as follows:
- radiopaque wire in AISI 316LVM .
- sizes .
VII. Performance Data
Testing was conducted according to written protocols with acceptance criteria. The following mechanical studies were performed in support of a substantial equivalence determination:
Non-Clinical Studies:
- . Risk that the cement restrictors are inadequate for femoral canal shape and not suitable for AMIS approach, Design Validation Report Nr: B1 and Design Validation Report Nr: B3
- Risk that Product range is not adequate to cover all the intended population, Design . Validation Report Nr: B1
- Risk of breakage of highly stressed parts, Design Validation Report Nr: B2 .
- Shelf Life Characterization of Medacta's Highly Crosslinked UHMWPE, Test Report ●
- . Pyrogenicity
- o Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination
- the subject devices are not labeled as non-pyrogenic or pyrogen free o
Clinical Studies
- No clinical studies were conducted .
VIII. Conclusion
The information provided with this submission supports that the subject devices are substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, indications for use, design and technological characteristics, as well as performance evaluations.