(90 days)
No
The summary describes a mechanical implant (acetabular system for hip replacement) and its materials and performance testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes.
The device is a component of a total hip arthroplasty system, which is intended to treat painful and/or disabled joints resulting from various medical conditions, as well as avascular necrosis and traumatic fractures. These uses fall under the definition of a therapeutic device as they are meant to treat, cure, or mitigate disease or injury.
No
Explanation: The device is an orthopaedic implant (acetabular system for total hip arthroplasty), used for treatment rather than diagnosis.
No
The device description clearly details physical components made of metal and plastic intended for surgical implantation, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "cementless use in total hip arthroplasty and in primary or revision surgery" to address conditions like osteoarthritis, avascular necrosis, fractures, and failure of previous hip surgeries. This describes a surgical implant used in vivo (within the body) to replace a joint.
- Device Description: The description details the physical components of the hip replacement system, including metal cups, polyethylene liners, bone screws, and ball heads. These are all physical devices designed for implantation.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or components.
Therefore, the Mpact® Acetabular System is a surgical implant, not an In Vitro Diagnostic device.
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, 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. t
- 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® Acetabular System components are designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, and K083558). The AMIStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Mpact® Acetabular System acetabular components that are the subject of this 510(k) consist of a metal cup made of Titanium alloy and a fixed liner that is made of ultra-high molecular weight polyethylene (UHMWPE) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE).
The metal acetabular component or shell is machined from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The outside of the metal component is a hemispherical design. The outer surface of the metallic cup has a porous coating called TiGrowth made of pure titanium conforming to ASTM F1580. The polyethylene liner is a fixed liner made of UHMWPE conforming to ISO 5834-2. The liner has a minimum thickness of at least 5.5 mm when made of standard UHMWPE and of least 4 mm when made of HXUHMWPE.
If supplemental bone screw fixation is needed, cancellous bone screws made of titanium alloy (Ti-6Al-4V) can be inserted through screw holes. Screw hole covers made of titanium alloy (Ti-6Al-4V) are also provided for the central hole.
Also included in this submission are additional Medacta ball heads made of CoCrMo in the 40 mm diameter to augment the Medacta ball heads previously cleared in K072857, K073337 and K080885.
The metal acetabular component is available in 11 sizes and is for use with polyethylene liners that accept both CoCrMo with diameters of 22, 28, 32, and 36 mm and MectaCer BIOLOX® forte Ceramic ball heads with diameters of 28, 32, and 36 mm. They also work with the Medacta 40 mm CoCrMo ball heads. The fixed liners are available in both flat and hooded options in a range of sizes.
All the Mpact® Acetabular System components and Medacta 40 mm ball heads are supplied sterile in single-use individual packages.
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)
Performance testing of the Mpact® Acetabular System was conducted in accordance with various international standards and FDA guidance documents.
The Mpact® Acetabular System and Medacta 40 mm ball heads were tested as part of design verification to written protocols with pre-defined acceptance criteria. The Mpact® testing was conducted on the worst case component size and option/design. The design verification testing included push out, lever out and rotational 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. The Medacta 40 mm ball heads testing were included in the worst case testing of the previously cleared ball heads. The testing met all acceptance criteria and verifies that the performance of the Mpact® Acetabular System and Medacta 40 mm ball heads are substantially equivalent to the predicate devices.
Wear Claim:
Medacta's Mpact® liners are made of HighCross™ highly crosslinked UHMWPE (ETO sterilized). The UHMWPE raw material, used for HighCross™ UHMWPE, is Chirulen 1020. The HighCross™ UHMWPE liners were gamma irradiated at 100 kGy and thermally stabilized at 150°C with controlled cooling, to optimize the crystallinity of the material. The liners were manufactured by turning compression molded UHMWPE bars and were finished products that followed all the manufacturing process flow including final sterilization.
The Mpact® liners tested were 4 mm thick, size Ø40/F. Testing was conducted under a multi-axial hip joint simulation with a standard walking gait cycle as specified by ISO 14242-1 with a 3.4 kN peak load for 5 million cycles using a 40 mm size M CoCrMo ball head and metal acetabular shell of size 54 mm. The lubricant was composed of calf serum with a 30 g/L protein content and deionized water. EDTA and Patricin were added to bind the calcium phosphate and to retard bacteria-induced degradation, respectively. The lubricant was filtered before doing the test and degraamon, replaced every 0.5 million cycles. The lubricant was replaced every 0.5 million cycles. Three liners were tested. Wear was measured at 0.5, 1, 2, 3, 4 and 5 million cycles.
Average gravimetric and volumetric wear rates were 6.28 mg +/- 1.68 mg per million Avelage grannon of - 1.8 mm3 per million cycles, respectively, for the Mpact® oycles and 0.78 HMWPE liners. The average total wear for 5 million cycles was 31.54 mg for the 40 mm inner diameter liners.
The in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of this wear claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average gravimetric and volumetric wear rates were 6.28 mg +/- 1.68 mg per million Avelage grannon of - 1.8 mm3 per million cycles, respectively, for the Mpact® oycles and 0.78 HMWPE liners. The average total wear for 5 million cycles was 31.54 mg for the 40 mm inner diameter liners.
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.
K071784, K001534, K070756, K101575, K100555, K083116, K092265, K091069, K072857, K080885
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
p. 1/5
Image /page/0/Picture/2 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a sans-serif font, with two triangles above the "M". Below the word "Medacta" is the word "International" in a smaller font. To the right of the word "International" is a small square with a plus sign inside.
MAR 2 1 20il
510(k) Summary
| Manufacturer: | 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: | Ms. Natalie J. Kennel
Consultant
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego, CA 92129 USA
Phone: (858) 705-0350
Fax: (858) 764-9739
email: nkennel@njkconsulting.com |
| ----------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
March 17, 2011 Date Prepared: :
DEVICE INFORMATION
| Trade/Proprietary Name: | Mpact® Acetabular System
Medacta 40 mm Ball heads |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Total Hip Acetabular Components
Femoral ball heads |
| Classification Name: | 21 CFR 888.3358 Hip joint, femoral metal/
polymer/metal semi-
constrained porous-coated 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
Class II |
Mpact® Acetabular System 510(k)
.
Section 5 - Page 1 of 5
1
Predicates:
K071784 DePuy Pinnacle® with Gription™ Acetabular Cups K001534 Pinnacle Acetabular System, DePuy Orthopedics K070756 REFLECTION 3 Acetabular System, Smith & Nephew K101575 Apex Modular Heads, +10.5 mm offset, Omni Lifesciences K100555 Apex- LNK Poly Acetabular Liners and Apex Modular Head, 40 mm, Omni Lifesciences K083116 Versafitcup® Double Mobility, Medacta International K092265 Versafitcup® Double Mobility HighCross® UHMWPE Liners, Medacta International K091069 Medacta Bone Screws, Medacta International K072857 Medacta Total Hip Prosthesis, Medacta International K080885 Medacta Total Hip Prosthesis CoCrMo ball heads, Medacta International
Product Description:
The Mpact® Acetabular System components are designed to be used with the Medacta Total Hip Prosthesis System. The Medacta Total Hip Prosthesis system includes the Quadra S, H, R, and C Stems and CoCrMo and ceramic ball heads (K072857, K073337, K080885, K082792, and K083558). The AMIStem femoral stems also work with the Medacta Total Hip Prosthesis System (K093944). The Medacta Total Hip Prosthesis System is a total hip replacement system consisting of the femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The Mpact® Acetabular System acetabular components that are the subject of this 510(k) consist of a metal cup made of Titanium alloy and a fixed liner that is made of ultra-high molecular weight polyethylene (UHMWPE) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE).
The metal acetabular component or shell is machined from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 and ASTM F136. The outside of the metal component is a hemispherical design. The outer surface of the metallic cup has a porous coating called TiGrowth made of pure titanium conforming to ASTM F1580. The polyethylene liner is a fixed liner made of UHMWPE conforming to ISO 5834-2. The liner has a minimum thickness of at least 5.5 mm when made of standard UHMWPE and of least 4 mm when made of HXUHMWPE.
If supplemental bone screw fixation is needed, cancellous bone screws made of titanium alloy (Ti-6Al-4V) can be inserted through screw holes. Screw hole covers made of titanium alloy (Ti-6Al-4V) are also provided for the central hole.
Also included in this submission are additional Medacta ball heads made of CoCrMo in the 40 mm diameter to augment the Medacta ball heads previously cleared in K072857, K073337 and K080885.
The metal acetabular component is available in 11 sizes and is for use with
Mpact® Acetabular System 510(k)
Section 5 - Page 2 of 5
2
polyethylene liners that accept both CoCrMo with diameters of 22, 28, 32, and 36 mm and MectaCer BIOLOX® forte Ceramic ball heads with diameters of 28, 32, and 36 mm. They also work with the Medacta 40 mm CoCrMo ball heads. The fixed liners are available in both flat and hooded options in a range of sizes.
All the Mpact® Acetabular System components and Medacta 40 mm ball heads are supplied sterile in single-use individual packages.
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 psoriatic arthritis, Congenital hip dysplasia, ankylosing spondylitis.
- Avascular necrosis of the femoral head. .
- Acute traumatic fracture of the femoral head or neck. t
- Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.
Wear Claim
Medacta's Mpact® liners are made of HighCross™ highly crosslinked UHMWPE (ETO sterilized). The UHMWPE raw material, used for HighCross™ UHMWPE, is Chirulen 1020. The HighCross™ UHMWPE liners were gamma irradiated at 100 kGy and thermally stabilized at 150°C with controlled cooling, to optimize the crystallinity of the material. The liners were manufactured by turning compression molded UHMWPE bars and were finished products that followed all the manufacturing process flow including final sterilization.
The Mpact® liners tested were 4 mm thick, size Ø40/F. Testing was conducted under a multi-axial hip joint simulation with a standard walking gait cycle as specified by ISO 14242-1 with a 3.4 kN peak load for 5 million cycles using a 40 mm size M CoCrMo ball head and metal acetabular shell of size 54 mm. The lubricant was composed of calf serum with a 30 g/L protein content and deionized water. EDTA and Patricin were added to bind the calcium phosphate and to retard bacteria-induced degradation, respectively. The lubricant was filtered before doing the test and degraamon, replaced every 0.5 million cycles. The lubricant was replaced every 0.5 million cycles. Three liners were tested. Wear was measured at 0.5, 1, 2, 3, 4 and 5 million cycles.
Average gravimetric and volumetric wear rates were 6.28 mg +/- 1.68 mg per million Avelage grannon of - 1.8 mm3 per million cycles, respectively, for the Mpact® oycles and 0.78 HMWPE liners. The average total wear for 5 million cycles was 31.54 mg for the 40 mm inner diameter liners.
3
The in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance. Also, a reduction in total polyethylene wear volume or wear rate alone may not result in an improved clinical outcome as wear particle size and morphology are also critical factors in the evaluation of the potential for wear mediated osteolysis and associated aseptic implant loosening. Particle size and morphology were not evaluated as part of this wear claim.
Comparison to Predicate Devices
The Mpact® Acetabular System family is similar to the DePuy Pinnacle® with Gription™ Acetabular Cups and the Smith & Nephew REFLECTION 3 Acetabular system in indications for use, design, materials, coating, and technological characteristics. The bone screws are similar to the Medacta Bone Screws in materials and design. The standard UHMWPE liners are made of the same material and process as the Versafitcup® Double Mobility standard UHMWPE liners. The HighCross® highly crosslinked UHMWPE liners of the Mpact® Acetabular System is the same HighCross® highly crosslinked UHMWPE of which the Versafitcup® Double Mobility HighCross® UHMWPE liners are made. The Medacta 40 mm ball heads are similar to Apex Modular heads in indications for use, material, size and options. The Medacta 40 mm ball heads have the same indications for use, material, design, and performance characteristics as the previously cleared CoCrMo ball heads in the Medacta Total Hip Prosthesis System.
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® Acetabular System was conducted in accordance with various international standards and FDA guidance documents.
The Mpact® Acetabular System and Medacta 40 mm ball heads were tested as part of design verification to written protocols with pre-defined acceptance criteria. The Mpact® testing was conducted on the worst case component size and option/design. The design verification testing included push out, lever out and rotational 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. The Medacta 40 mm ball heads testing were included in the worst case testing of the previously cleared ball heads. The testing met all acceptance criteria and verifies that the performance of the Mpact® Acetabular System and Medacta 40 mm ball heads are substantially equivalent to the predicate devices.
Conclusion:
The data and information provided in this submission support the conclusion that the Mpact® Acetabular System and Medacta 40 mm ball head are substantially equivalent to its main' predicates devices: DePuy Pinnacle® with Gription® eqarabular Cups and Smith & Nephew REFLECTION 3 Acetabular System with respect to indications for use and technological characteristics. The Mpact® Acetabular System is also substantially equivalent to the Medacta Bone Screws and Versafitcup® Double Mobility and Versafitcup® Double Mobility HighCross® I crounted.po to the chnological characteristics. The Medacta 40 mm ball heads are
Section 5 - Page 4 of 5
4
p. 5/5
substantially equivalent to the Apex Modular heads and the Medacta Total Hip Prosthesis CoCrMo ball heads with respect to indications for use and technological characteristics.
. .
5
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird in flight, with its wings and body represented by curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Medacta International SA % NJK & Associates, Inc. Ms. Natalie J. Kennel 13721 Via Tres Vista San Diego, California 92129
MAR 2 1 201
Re: K103721
Trade/Device Name: Mpact® Acetabular System
Regulation Number: 21 CFR 888.3358
Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Regulatory Class: II Product Code: LPH, LZO Dated: December 14, 2010 Received: December 21, 2010
Dear Ms. Kennel:
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
6
Page 2 - Ms. Natalie J. Kennel
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for D. Holmquist
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known):
Device Name: Mpact® Acetabular System
Indications for Use:
The Mpact® Acetabular System is intended for cementless use in total hip arthroplasty and 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, or 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 x Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for n. melkerson
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Page _ of _ l
510(k) Number K103721