(260 days)
No
The summary describes a line extension of hip implants made of standard materials and tested using standard mechanical and biological methods. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a total hip arthroplasty implant intended to treat severely painful and/or disabled joints, avascular necrosis, or acute traumatic fracture of the femoral head or neck, which are conditions that it directly treats or alleviates.
No
Explanation: The device description and intended use clearly state that the Mpact Extension implants are "sterile implantable devices intended to be used during Total Hip Arthroplasty." They are components for hip replacement surgery, not devices designed for diagnosing conditions.
No
The device description clearly states that the device is a sterile implantable device made of physical materials (Ti6Al4V, UHMWPE) and is intended to be used during Total Hip Arthroplasty, which involves physical implantation. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip arthroplasty (hip replacement surgery) to treat conditions affecting the hip joint. This is a surgical procedure performed on the patient's body.
- Device Description: The device is described as sterile implantable devices (acetabular shells and liners) made of materials like Ti6Al4V and UHMWPE. These are physical implants designed to replace parts of the hip joint.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
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, 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 implants are a line extension to Medacta's Mpact (K103721) and Mpact Extensions (K122641, K132879, K183582 and K200391) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are:
- Liners sizes 22/A and 28/A of each design type (flat, hooded, offset +4mm and face changing +10°);
- Acetabular Shells size Ø44 of each design type (No-hole, Two-holes and Multi-holes);
- Acetabular Shells sizes from Ø42T to Ø58T of each design type (No-hole, Two-holes and Multi-holes) allowing to be coupled with an increase size of liner.
The Mpact Extension implants are sterile implantable devices intended to be used during Total Hip Arthroplasty: the acetabular shells together with their respective liners are used to replace the acetabulum.
Analogously to the predicate devices, the subject acetabular shells are made of Ti6Al4V according to ASTM F136-13 and Ti coated according to ASTM F1580-18, while the subject liners are made of High-Cross ultra-high molecular weight polyethylene (UHMWPE).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint / Acetabulum / Femoral head or neck
Indicated Patient Age Range
Skeletally mature
Intended User / Care Setting
Prescription Use
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:
- PERFORMANCE TESTING
- Mpact range extension Acetabular cup fatigue assessment
- Mpact range extension Acetabular cup deformation assessment
- MPACT PE HC liners size A Stability test report according to ASTM F1820 Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
- Mpact new sizes Evaluation of impingement risk rationale
- Mpact range extension Evaluation of ROM according to EN ISO 21535 Non-active Surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
- Mpact PE HC liner sizes Ø22/A and Ø28/A Rationale for wear test
- PYROGENICITY
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- Pyrogen test according to USP chapter for pyrogenicity determination
- The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY assessment
- SHELF-LIFE evaluation
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.
K103721, K132879, K122641, K183582
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2023
Medacta International S.A. % Chris Lussier Senior Director, Ouality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K230011
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: August 21, 2023 Received: August 22, 2023
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 may, 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.
1
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 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 (QS) 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.
Limin S
Limin Sun, Ph.D. 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
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Indications for Use
510(k) Number (if known)
K230011
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, 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
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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, Sr. Director, Quality, Regulatory, and Clinical, Medacta USA Date Prepared: September 20, 2023
II. Device
| Device Proprietary Name: | Mpact Extension |
|---|---|
| Common or Usual Name: | Total Hip Acetabular Components |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis |
| Primary Product Code: | LPH |
| Secondary Product code | LZO |
| Regulation Number: | 21 CFR 888.3358 and 21 CFR 888.3353 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following predicate devices: Primary predicate device
-
Medacta International SA, MPACT, K103721 ●
Additional predicate devices -
Medacta International SA, MPACT Extension, K132879 ●
-
Medacta International SA, MPACT Extension, K122641 ●
-
. Medacta International SA, MPACT Extension, K183582
Reference device:
- Medacta International SA, Versafitcup CC Trio, K103352 ●
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IV. Device Description
The Mpact Extension implants are a line extension to Medacta's Mpact (K103721) and Mpact Extensions (K122641, K132879, K183582 and K200391) Systems and are designed to be used with the Medacta Total Hip Prosthesis System. Specifically, the devices subject of this submission are:
- Liners sizes 22/A and 28/A of each design type (flat, hooded, offset +4mm and face changing . +10°);
- Acetabular Shells size Ø44 of each design type (No-hole, Two-holes and Multi-holes); ●
- Acetabular Shells sizes from Ø42T to Ø58T of each design type (No-hole, Two-holes and Multi-● holes) allowing to be coupled with an increase size of liner.
The Mpact Extension implants are sterile implantable devices intended to be used during Total Hip Arthroplasty: the acetabular shells together with their respective liners are used to replace the acetabulum.
Analogously to the predicate devices, the subject acetabular shells are made of Ti6Al4V according to ASTM F136-13 and Ti coated according to ASTM F1580-18, while the subject liners are made of High-Cross ultra-high molecular weight polyethylene (UHMWPE).
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.
Comparison of Technological Characteristics VI.
The Mpact Extension implants are identical to the predicate devices, Mpact System (K103721, K122641, K132879 and K183582), with regards to the following characteristics:
- substrate and coating materials; ●
- biocompatibility:
- device usage;
- sterility; ●
- shelf-life; and ●
- packaging.
The Mpact Extension implants differ from the predicate devices, Mpact System (K103721, K122641, K132879 and K183582), with respect to:
5
- sizes:
- acetabular shells compatibility with liners;
- liners locking mechanism (nº of tabs); and ●
- acetabular shells coating thickness. ●
VII. Performance Data
Based on the risk analysis, performance testing were conducted to written protocols. The following rationales and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- PERFORMANCE TESTING ●
- Mpact range extension Acetabular cup fatigue assessment o
- Mpact range extension Acetabular cup deformation assessment O
- MPACT PE HC liners size A Stability test report according to ASTM F1820 Standard Test o Method for Determining the Axial Disassembly Force of a Modular Acetabular Device
- Mpact new sizes Evaluation of impingement risk rationale O
- Mpact range extension Evaluation of ROM according to EN ISO 21535 Non-active Surgical о implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
- Mpact PE HC liner sizes Ø22/A and Ø28/A Rationale for wear test o
- PYROGENICITY ●
- 0 Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- 0 Pyrogen test according to USP chapter for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
- BIOCOMPATIBILITY assessment ●
- SHELF-LIFE evaluation
Clinical Studies:
- No clinical studies were conducted. ●
Conclusion VIII.
The information provided above supports that the subject Mpact Extension devices are substantially equivalent to the predicate devices.