(134 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a hip prosthesis component, with no mention of AI or ML.
Yes.
The device is a hip prosthesis designed to treat severe pain and disability in the hip joint due to various conditions, indicating a therapeutic purpose.
No
Explanation: The device described is a hip prosthesis component (Mpact DM Converter) designed for use in total hip arthroplasty, which is a therapeutic treatment. It is not used to diagnose a medical condition.
No
The device description clearly describes a physical hip prosthesis component made of CoCrMo and UHMWPE, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (hip prosthesis) for treating conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip prosthesis (liner, shell, materials) and how they function mechanically within the body. This is consistent with a medical device used for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing information for diagnosis. The device is implanted directly into the patient.
- Performance Studies: The performance studies focus on mechanical properties and wear, which are relevant to the function and durability of an implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used to replace a damaged joint.
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, posttraumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankvlosing spondvlitis.
- 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.
Product codes
LZO, MEH
Device Description
The Mpact DM Converter is a highly polished CoCrMo (ASTM F1537) liner with a tapered locking mechanism which assures the connection with the acetabular shell. The Mpact DM Converter can only be coupled with Medacta Double Mobility UHMWPE (ISO 5834-2 Type 1) liners (K083116) or HighCross® highly crosslinked UHMWPE liners (K092265) and can only be used with Mpact Primary (K103721) or Mpact Extension (K122641) acetabular shells.
The Mpact DM Converter has a 5° shoulder which increases the jump distance and it also has a small tooth which can be used in case of revision to extract the liner. The six available sizes have a nomenclature that identifies the cup liner size (first letter) and the double mobility liner size (final three letters): D/DMB, E/DMC, F/DME, G/DMF, J/DMH and K/DML.
This submission also includes one new size (22.2/DMB) of the Medacta Double Mobility liner in both UHMWPE (ISO 5834-2 Type 1) and HighCross® highly crosslinked UHMWPE. These liners are identical to the liners in the K083116 and K092265 submissions but have a smaller external diameter than the predicates. These new liners can only be coupled with a 22.2mm ball 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
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)
The Mpact Extension was tested as part of design verification to written protocols with pre-defined acceptance criteria. The Mpact DM Converter testing was conducted on the worst case component size and option/design. The Mpact DM Converter was tested for range of motion, pull-off, push-out, torsion, wear, fretting corrosion, and jump distance.
The comparison to predicate devices and the mechanical testing performed demonstrate that the Mpact DM Converter is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K103721, K122641, K083116, K092265, K103233
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
K131458 (pg 1/3)
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a stylized font, with two triangles above the word. Below the word "Medacta" is the word "International" and a symbol that looks like a plus sign.
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
OCT 0 1 2013
Mr. Adam Gross Contact Person: Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805) 322-3289 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: May 17, 2013
DEVICE INFORMATION
Trade/Proprietary Name: Mpact DM Converter Common Name: Total Hip Acetabular Components Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
21 CFR 888.3353 Class II Device Product Codes: LZO, MEH
Predicate Devices:
| 510(k) | Product | 510(k) Holder | Clearance |
|---|---|---|---|
| K103721 | Mpact Acetabular System | Medacta International | 3/21/2011 |
| K122641 | Mpact Extension | Medacta International | 9/28/2012 |
| K083116 | Versafitcup Double Mobility | Medacta International | 4/7/2009 |
| K092265 | Versafitcup Double Mobility Highcross Liners | Medacta International | 3/12/2010 |
| K103233 | MDM | Stryker | 2/3/2011 |
Mpact DM Converter 510(k)
1
Product Description
The Mpact DM Converter is a highly polished CoCrMo (ASTM F1537) liner with a tapered locking mechanism which assures the connection with the acetabular shell. The Mpact DM Converter can only be coupled with Medacta Double Mobility UHMWPE (ISO 5834-2 Type 1) liners (K083116) or HighCross® highly crosslinked UHMWPE liners (K092265) and can only be used with Mpact Primary (K103721) or Mpact Extension (K122641) acetabular shells.
The Mpact DM Converter has a 5° shoulder which increases the jump distance and it also has a small tooth which can be used in case of revision to extract the liner. The six available sizes have a nomenclature that identifies the cup liner size (first letter) and the double mobility liner size (final three letters): D/DMB, E/DMC, F/DME, G/DMF, J/DMH and K/DML.
This submission also includes one new size (22.2/DMB) of the Medacta Double Mobility liner in both UHMWPE (ISO 5834-2 Type 1) and HighCross® highly crosslinked UHMWPE. These liners are identical to the liners in the K083116 and K092265 submissions but have a smaller external diameter than the predicates. These new liners can only be coupled with a 22.2mm ball 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, posttraumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankvlosing spondvlitis.
- 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.
Comparison to Predicate Devices
Mpact DM Converter 510(k)
2
K131458 (pg 3/3)
The indications for use of the Mpact DM Converter are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the Mpact DM Converter are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Performance Testing
The Mpact Extension was tested as part of design verification to written protocols with pre-defined acceptance criteria. The Mpact DM Converter testing was conducted on the worst case component size and option/design. The Mpact DM Converter was tested for range of motion, pull-off, push-out, torsion, wear, fretting corrosion, and jump distance.
The comparison to predicate devices and the mechanical testing performed demonstrate that the Mpact DM Converter is substantially equivalent.
Conclusion:
Based on the above information, the Mpact DM Converter can be considered as substantially equivalent to its predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2013
Medacta International % Mr. Adam Gross Medacta USA 4725 Calle Quetzal. Unit B Camarillo, California 93012
Re: K131458
Trade/Device Name: Mpact DM Converter Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: July 2, 2013 Received: July 3, 2013
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
4
Page 2 - Mr. Adam Gross
device-related adverse cvents) (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers. International and Consumer Assistance 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 yours.
Erin-D.Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K131458
Device Name: Mpact DM Converter
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, posttraumatic . 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.
Prescription Use × (21 CFR 801 Subpart D)
· AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices