(435 days)
Not Found
No
The document describes standard hip implants and screws, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an implantable hip component (total hip arthroplasty) intended to treat severely painful and disabled joints due to various conditions like arthritis, avascular necrosis, or acute traumatic fractures. These uses directly involve treating or mitigating a disease or injury, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is an "MPACT Extension implant" consisting of "Cancellous Bone Screws" intended for "cementless use in total hip arthroplasty in primary or revision surgery." These are surgical implants used in treatment, not for diagnosing a condition.
No
The device description clearly states the device is a sterile implantable device made of titanium alloy, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as an implant for total hip arthroplasty (hip replacement surgery). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as sterile implantable devices (cancellous bone screws) made of titanium alloy, intended for fixation during hip replacement surgery. This is a physical implant, not a diagnostic tool that analyzes samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to replace or augment a joint.
N/A
Intended Use / Indications for Use
The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
- · Avascular necrosis of the femoral head.
- · Acute traumatic fracture of the femoral head or neck.
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Mpact 3D Metal Implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
• Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.
The Augments 3D Metal are indicated in cases of:
- Congenital dysplasia.
- · Acetabular fractures.
· Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.
The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
-
· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis or
psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis -
Avascular necrosis of the femoral head
-
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplastv, or total hip replacement where sufficient bone stock is present.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, MEH
Device Description
The MPACT Extension implants subject of this submission are twelve (12) sizes of Cancellous Bone Screws.
The subject devices are sterile implantable devices intended to be used during Total Hip Arthroplasty.
Analogously to the predicate Cancellous Bone Screws flat head (K103721 and K132879), the subject Cancellous Bone Screws, are made of titanium alloy (Ti6-A14-V) according to ISO 5832-3:2016 Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4vanadium allov. As the predicate devices, they have been designed with a thread diameter of 6.5 mm to provide fixation of implants to the cancellous bone. They can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm.
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
The patient should be skeletally mature.
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
- Cancellous Bone Screw Ø6.5 design Validation rationale A1 item 3
- Cancellous Bone Screw Ø6.5 acetabular shell compatibility Validation rationale A2 item 3
- BIOCOMPATIBILITY evaluation according to ISO 10993
- SHELF-LIFE testing according to ISO 11607-1 and ISO 11607-2
- PYROGENICITY
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination that the O 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.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
April 28, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, and the full name of the agency is in blue text.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K200391
Trade/Device Name: MPACT Extension Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: March 31, 2021 Received: April 1, 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 (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,
Vesa 2021.04.28
16:46:25
Vuniqi -S -04'00'
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200391
Device Name MPACT Extension
Indications for Use (Describe)
The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
- · Avascular necrosis of the femoral head.
- · Acute traumatic fracture of the femoral head or neck.
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Mpact 3D Metal Implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
• Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.
The Augments 3D Metal are indicated in cases of:
- Congenital dysplasia.
- · Acetabular fractures.
· Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.
The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
-
· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis or
psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis -
Avascular necrosis of the femoral head
-
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplastv, or total hip replacement where sufficient bone stock is present.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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 14, 2020 Date Revised: April 23, 2021
II. Device
| Device Proprietary Name: | MPACT Extension |
|---|---|
| Common or Usual Name: | Cancellous Bone Screws |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous- |
| coated uncemented prosthesis | |
| Primary Product Code: | LPH |
| Secondary Product code | LZO, MEH |
| Regulation Number: | 21 CFR 888.3358 and 21 CFR 888.3353 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device
-
. Medacta International SA, MPACT, K103721
Additional predicate device -
Medacta International SA, MPACT Extension, K132879 .
IV. Device Description
The MPACT Extension implants subject of this submission are twelve (12) sizes of Cancellous Bone Screws.
The subject devices are sterile implantable devices intended to be used during Total Hip Arthroplasty.
5
Analogously to the predicate Cancellous Bone Screws flat head (K103721 and K132879), the subject Cancellous Bone Screws, are made of titanium alloy (Ti6-A14-V) according to ISO 5832-3:2016 Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4vanadium allov. As the predicate devices, they have been designed with a thread diameter of 6.5 mm to provide fixation of implants to the cancellous bone. They can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm.
V. Indications for Use
The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, . rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis.
- 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Mpact 3D Metal Implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.
The patient's condition should be due to one or more of:
- . Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
- 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, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multihole acetabular cup in hip replacement surgeries.
The Augments 3D Metal are indicated in cases of:
- . Congenital dysplasia.
- Acetabular fractures. .
- . Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.
The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of:
- Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, . rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis
- Avascular necrosis of the femoral head .
- Acute traumatic fracture of the femoral head or neck ●
6
- Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, . hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
Comparison of Technological Characteristics VI.
The subject Cancellous Bone Screws and the predicate MPACT cancellous bone screws flat head (K103721 and K132879) share the following characteristics:
- . sizes;
- thread diameter .
- . head shape
- . material;
- biocompatibility;
- . device usage;
- sterility;
- shelf life; and .
- packaging. .
The subject Cancellous Bone Screws differ from the predicate devices with respect to:
- neck diameter .
- . head height
- screw tip shape. .
7
VII. Performance Data
Testing was conducted according to written protocols. The following studies were performed in support of a substantial equivalence determination:
Non-Clinical Studies:
- . DESIGN VALIDATION
- 0 Cancellous Bone Screw Ø6.5 design Validation rationale A1 item 3
- o Cancellous Bone Screw Ø6.5 acetabular shell compatibility Validation rationale A2 item 3
- . BIOCOMPATIBILITY evaluation according to ISO 10993
- SHELF-LIFE testing according to ISO 11607-1 and ISO 11607-2 .
- . PYROGENICITY
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination that the O subject devices are not labeled as non-pyrogenic or pyrogen free
Clinical Studies
- No clinical studies were conducted ●
VIII. Conclusion
Based on the above information, the MPACT Extension implants are substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as design validations.