(131 days)
No
The device description and performance studies focus on mechanical properties and design modifications of a hip prosthesis, with no mention of AI or ML.
Yes
The device is a hip prosthesis, which is designed to treat severely painful and/or disabled joints, avascular necrosis, acute traumatic fractures, and failures of previous hip surgery by replacing the hip joint, thereby restoring function and alleviating symptoms.
No
Explanation: The device is a hip prosthesis, which is an implant designed for surgical replacement of a hip joint. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly lists physical components made of materials like Ti-6AI-4V, UHMWPE, and Ti, which are hardware components of a hip prosthesis. There is no mention of software as the primary or sole component.
Based on the provided information, 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 components of a hip prosthesis system (acetabular shells, liners, bone screws). These are physical implants used in surgery.
- Performance Studies: The performance studies focus on mechanical properties and stability of the implant components (pull-off, lever-out, torsional stability, wear, etc.). These are relevant to the function and safety of a surgical implant, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension consists of the following components:
Revised dimensions and labeling of the acetabular shells (Ti-6AI-4V, ASTM F136 and Ti, ASTM F1580 porous coating) cleared under K103721 and K122641 to correlate to the actual external diameter including the porous coating.
Modified design of the hooded acetabular liners (UHMWPE ISO 5834-2 Type1 and HighCross® HXUHMWPE) cleared under K103721 and K122641. The modification of the hooded liner is specific to the external side of the anti-luxation shoulder, creating a chamfer in order to reduce the risk of psoas irritation.
Additional sizes of the cancellous bone screws (flat head, 6.5mm diameter, Ti-6Al-4V ISO 5832-3) cleared under K103721 with lengths of 50, 55, 60, 65, and 70mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act, Performance testing of the Mpact Extension was conducted in accordance with various international standards and FDA guidance documents. The Mpact Extension was tested as part of design verification to written protocols with pre-defined acceptance criteria. The Mpact Extension testing was conducted on the worst case component size and option/design.
The design verification activities included the assessment of pull-off, lever-out and torsional stability of the modular connection of the fixed liner to the metal shell, coating validation, metal shell deformation resistance during impaction, range of motion, wear, and bone screw testing. Either a dimensional or FEM analysis was completed as part of the design activities and no new worst case constructs were identified except for the bone screw. Therefore, testing per ASTM F543 was completed on the bone screws, with the results meeting the acceptance criteria. No other mechanical testing was performed.
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
Page 1 of 3
JAN 2 2 2014
Image /page/0/Picture/3 description: The image shows the logo for Medacta International. The logo consists of two black triangles pointing upwards, followed by the word "Medacta" in a sans-serif font. Below the word "Medacta" is a thin line, and below that is the word "International" in a smaller font, followed by a small square with a cross inside.
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: Mr. Adam Gross 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
September 10, 2013 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: Mpact Extension Common Name: Total Hip Acetabular Components Class II
Classification Name: 21 CFR 888.3358 - Hip joint, femoral metal/polymer/metal semiconstrained porouscoated uncemented prosthesis Device Product Code: LPH
- 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Device Product Code: LZO
Predicate Devices:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K103721 | Mpact Acetabular System | Medacta International | 3/21/2011 |
| K122641 | Mpact Extension | Medacta International | 9/28/2012 |
| K033338 | Pinnacle Revision Cup System | Depuy | 1/8/2004 |
Mpact Extension 510(k)
Section 5 - Page 2 of 4
1
Product Description
The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension consists of the following components:
Revised dimensions and labeling of the acetabular shells (Ti-6AI-4V, ASTM F136 and Ti, ASTM F1580 porous coating) cleared under K103721 and K122641 to correlate to the actual external diameter including the porous coating.
Modified design of the hooded acetabular liners (UHMWPE ISO 5834-2 Type1 and HighCross® HXUHMWPE) cleared under K103721 and K122641. The modification of the hooded liner is specific to the external side of the anti-luxation shoulder, creating a chamfer in order to reduce the risk of psoas irritation.
Additional sizes of the cancellous bone screws (flat head, 6.5mm diameter, Ti-6Al-4V ISO 5832-3) cleared under K103721 with lengths of 50, 55, 60, 65, and 70mm.
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 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.
Comparison to Predicate Devices
The indications for use of the Mpact Extension 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
Mpact Extension 510(k)
Section 5 - Page 3 of 4
2
K132879
technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the Mpact Extension are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act, Performance testing of the Mpact Extension was conducted in accordance with various international standards and FDA guidance documents. The Mpact Extension was tested as part of design verification to written protocols with pre-defined acceptance criteria. The Mpact Extension testing was conducted on the worst case component size and option/design.
The design verification activities included the assessment of pull-off, lever-out and torsional stability of the modular connection of the fixed liner to the metal shell, coating validation, metal shell deformation resistance during impaction, range of motion, wear, and bone screw testing. Either a dimensional or FEM analysis was completed as part of the design activities and no new worst case constructs were identified except for the bone screw. Therefore, testing per ASTM F543 was completed on the bone screws, with the results meeting the acceptance criteria. No other mechanical testing was performed.
Conclusion:
Based on the above information, the Mpact Extension can be considered as substantially equivalent to its predicate devices.
Section 5 - Page 4 of 4
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and monochromatic.
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
January 22, 2014
Medacta International SA % Mr. Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 4725 Calle Quetzal, Unit B Camarillo, California 93012
Re: K132879
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 Dated: October 23, 2013 Received: October 24, 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 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.
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" (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 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.
Ronald##Jean -S 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): K132879
Device Name: Mpact Extension
. . . .. . .
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