(89 days)
Not Found
No
The summary describes a mechanical hip prosthesis system and its components, focusing on materials, design, and performance testing related to mechanical properties and wear. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a hip prosthesis designed for total hip arthroplasty to treat painful and/or disabled joints, avascular necrosis, traumatic fractures, or failure of previous hip surgery, thereby providing a therapeutic benefit to the patient.
No
The device is a hip prosthesis designed for surgical implantation to replace a diseased or damaged hip joint, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components (acetabular shells, liners) made of specific materials and coatings, which are hardware. The performance studies also focus on physical properties and mechanical testing of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation as a hip prosthesis to treat various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant (acetabular shells and liners) designed to replace or augment the hip joint. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- No mention of in vitro testing: The description and performance studies focus on the mechanical and material properties of the implant and its performance within the body (e.g., wear, range of motion, dislocation risk). There is no mention of testing biological samples outside of the body.
Therefore, this device is a medical device, specifically a prosthetic implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The hip prosthesis is 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, rheumatod arthritis or psoriactic 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.
• Dislocation risks
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, MEH
Device Description
The Mpact Double Mobility System acetabular shells are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Double Mobility System consists of acetabular shells (size 42mm to 66mm in 2mm increments) that have a TiGrowth porous coating (Ti, ASTM F1580) and hemispherical shape that is identical to the K103721 and K132879 predicate devices. The material of the shells (High Nitrogen StSt - ISO 5832-9) and the double mobility design is the same as the K083116 predicate device.
The shells are used with the Versafitcup Double Mobility Liners that are registered with K083116, K092265, and K131458 predicate devices in addition to one new size (22.2/DMA) of the Medacta Double Mobility liner in both UHMWPE (ISO 5834-2 Type 1) and HighCross highly crosslinked UHMWPE which are included in this submission. These liners are identical to the liners in the K083116, K092265, and K131458 submissions but have a smaller external diameter than the predicates. These new liners can only be coupled with a 22.2mm femoral head and have a minimum thickness of 5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
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)
The Mpact Double Mobility System was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The Mpact Double Mobility System was compared to the worst case predicate device and it was determined that the Mpact Double Mobility System is not worst case.
Mpact Double Mobility System has similar performance testing as the predicates in terms of:
Acetabular shell:
Coating adhesion and chemical characterization
Friction test ASTM G115-04 and ASTM D4518-94 ●
lon release and corrosion test ASTM F746-04 0
Acetabular shell and liner:
Excessive wear during motion
Limited ROM .
Dislocation Risk
Acetabular liner:
. Instability risk of the modular connection of the Mpact Double Mobility Liner and femoral head
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.
K083116, K092265, K103721, K132879, K131458
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2015
Medacta USA Mr. Adam Gross Director of Regulatory, Quality and Compliance 1556 West Carroll Avenue Chicago, Illinois 60607
Re: K143453 Trade/Device Name: Mpact Double Mobility System 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: December 22, 2014 Received: December 30, 2014
Dear Mr. Gross:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Adam Gross
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.
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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 vours.
Lori A. Wiggins -S
for 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) K143453
Device Name Mpact Double Mobility System
Indications for Use (Describe)
The hip prosthesis is 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, rheumatod arthritis or psoriactic 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.
• Dislocation risks
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
K143453 Page 1 of 3
Image /page/3/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two blue triangles, the word "Medacta" in blue, a yellow line underneath the word, and the word "International" in gray. There is also a Swiss flag to the right of the word "International".
510(k) Summary
Applicant/Sponsor: 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: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: (805) 910-6511 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: November 19, 2014
DEVICE INFORMATION
Trade/Proprietary Name: Mpact Double Mobility System Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Class II 21 CFR 888.3358, Product Code LPH 21 CFR 888.3353, Product Code LZO, MEH
Predicate Device(s):
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K083116 | Versafitcup Double Mobility | Medacta International | 4/7/2009 |
| K092265 | Versafitcup DM Highly Crosslinked | Medacta International | 3/12/2010 |
| K103721 | Mpact Acetabular System | Medacta International | 3/21/2011 |
| K132879 | Mpact Extension | Medacta International | 1/22/2014 |
| K131458 | Mpact DM Converter | Medacta International | 10/1/2013 |
4
Product Description
The Mpact Double Mobility System acetabular shells are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Double Mobility System consists of acetabular shells (size 42mm to 66mm in 2mm increments) that have a TiGrowth porous coating (Ti, ASTM F1580) and hemispherical shape that is identical to the K103721 and K132879 predicate devices. The material of the shells (High Nitrogen StSt - ISO 5832-9) and the double mobility design is the same as the K083116 predicate device.
The shells are used with the Versafitcup Double Mobility Liners that are registered with K083116, K092265, and K131458 predicate devices in addition to one new size (22.2/DMA) of the Medacta Double Mobility liner in both UHMWPE (ISO 5834-2 Type 1) and HighCross highly crosslinked UHMWPE which are included in this submission. These liners are identical to the liners in the K083116, K092265, and K131458 submissions but have a smaller external diameter than the predicates. These new liners can only be coupled with a 22.2mm femoral head and have a minimum thickness of 5 mm.
Indications for Use
The hip prosthesis is 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 psoriactic 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.
• Dislocation risks
Comparison to Predicate Devices
The indications for use, design features and materials of the Mpact Double Mobility System are substantially equivalent to those of the predicate devices. The substantial equivalence of the Mpact Double Mobility System implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.
5
Performance Testing
The Mpact Double Mobility System was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The Mpact Double Mobility System was compared to the worst case predicate device and it was determined that the Mpact Double Mobility System is not worst case.
Mpact Double Mobility System has similar performance testing as the predicates in terms of:
Acetabular shell:
- Coating adhesion and chemical characterization
- Friction test ASTM G115-04 and ASTM D4518-94 ●
- lon release and corrosion test ASTM F746-04 0
Acetabular shell and liner:
- Excessive wear during motion
- Limited ROM .
- Dislocation Risk
Acetabular liner:
- . Instability risk of the modular connection of the Mpact Double Mobility Liner and femoral head
Conclusion:
Based on the above information, the Mpact Double Mobility System can be considered as substantially equivalent to its predicate devices.