(66 days)
No
The document describes a hip prosthesis system, focusing on materials, sizes, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is a total hip prosthesis system intended for hip replacement due to various conditions like arthritis or fractures, aiming to alleviate pain and restore joint function. This fits the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The device is a total hip prosthesis system, which is an implant used for hip replacement surgery. Its intended use is to replace a diseased or damaged hip joint, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium alloy and hydroxyapatite coating, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this is a Total Hip Prosthesis System, which is an implantable device used in surgery to replace a damaged hip joint.
- Intended Use: The intended use is for total or partial hip arthroplasty (hip replacement surgery), which is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
- · Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- · 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.
Product codes
LZO, MEH
Device Description
The AMIStem and Quadra - Line Extension is comprised of the following femoral stems:
- Quadra H STD #00 Short neck ●
- Quadra S STD #00 Short neck .
- AMIStem H STD Stem #00 ●
- AMIStem H LAT Stem #0
- AMIStem H Collared STD and LAT, multiple sizes
The subject devices have the same material as the predicate devices (titanium alloy, according to ISO 5832-11, 1994, Implants for surgery - Metallic materials - part 11: Wrought titanium 6-aluminum 7-niobium alloy).
The AMIStem H and Quadra H have the same coating as the predicate devices: Hydroxyapatite coating, material according to ASTM F1185.
The Quadra H STD #00 Short neck, Quadra S STD #00 Short neck, AMIStem H STD Stem #00, and AMIStem H LAT Stem #0 are a smaller size than the predicate devices and are intended for patients with a smaller bone structure.
The AMIStem H Collared differs from the AMIStem H (KQ93944) only for the presence of the collar. The collar of the stem is designed to achieve contact only with the medial femoral cortex and to provide a path for direct axial stress transfer from the prosthesis to the proximal femur avoiding the over-insertion of the stem in case of subsidence.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (Femoral Head or Neck)
Indicated Patient Age Range
Not Found
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 AMIStem and Quadra - Line Extension was tested in accordance with ISO 7206-4 and ISO 7206-6. The subject devices did not raise any new issues of safety and effectiveness and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3353 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
JUN - 8 2012
Image /page/0/Picture/2 description: The image shows the word "Medacta" in a simple, sans-serif font. The first letter, "M", is stylized with two triangles pointing upwards, creating a unique visual element. A horizontal line runs beneath the entire word, adding a subtle emphasis to the logo. The overall design is clean and modern, suggesting a professional and reliable brand.
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: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com
Date Prepared: 03/30/2012
DEVICE INFORMATION
Trade/Proprietary Name: AMIStem and Quadra - Line Extension Common Name: Femoral Stem 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: K072857 - Medacta Total Hip Prosthesis System-Quadra S, CoCr Ball Heads, Medacta International K082792 - Quadra H; Quadra R, Medacta International K093944 - AMIStem H; Quadra S-H (SN), Medacta International
AMIStem and Quadra - Line Extension 510(k)
Section 5 - Page 2 of 4
1
Product Description
The AMIStem and Quadra - Line Extension is comprised of the following femoral stems:
- Quadra H STD #00 Short neck ●
- Quadra S STD #00 Short neck .
- AMIStem H STD Stem #00 ●
- AMIStem H LAT Stem #0
- AMIStem H Collared STD and LAT, multiple sizes
The subject devices have the same material as the predicate devices (titanium alloy, according to ISO 5832-11, 1994, Implants for surgery - Metallic materials - part 11: Wrought titanium 6-aluminum 7-niobium alloy).
The AMIStem H and Quadra H have the same coating as the predicate devices: Hydroxyapatite coating, material according to ASTM F1185.
The Quadra H STD #00 Short neck, Quadra S STD #00 Short neck, AMIStem H STD Stem #00, and AMIStem H LAT Stem #0 are a smaller size than the predicate devices and are intended for patients with a smaller bone structure.
The AMIStem H Collared differs from the AMIStem H (KQ93944) only for the presence of the collar. The collar of the stem is designed to achieve contact only with the medial femoral cortex and to provide a path for direct axial stress transfer from the prosthesis to the proximal femur avoiding the over-insertion of the stem in case of subsidence.
Indications for Use
The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
- · Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- · 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.
Section 5 - Page 3 of 4
2
Comparison to Predicate Devices
The intended use, materials, and performance characteristics for all of the femoral stems that are the subject of this submission are the same as the correspondent femoral stems already registered in the predicate devices.
Performance Testing
The AMIStem and Quadra - Line Extension was tested in accordance with ISO 7206-4 and ISO 7206-6. The subject devices did not raise any new issues of safety and effectiveness and are substantially equivalent to the predicate devices.
Conclusion:
Based on the above information, the AMIStem and Quadra - Line Extension can be considered as substantially equivalent to its predicate devices.
AMIStem and Quadra - Line Extension 510(k)
Section 5 - Page 4 of 4
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three curved shapes resembling a person embracing or supporting another, representing the department's mission of providing essential services and protecting the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medacta International % Medacta USA Mr. Adam Gross Director of Regulatory and Quality 4725 Calle Quetzal, Unit B Camarillo, CA 93012
Re: K121011
Trade/Device Name: AMIStem and Quadra - Line Extension 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: May 8, 2012 Received: May 9, 2012
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
JUN - 8 2012
4
Page 2 - Mr. Adam Gross
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 forth in the quality systems (OS) 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/ReportalProblem/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,
Erin D. Keith
+s Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: AMIStem and Quadra - Line Extension
Indications for Use:
The Medacta Total Hip Prosthesis System is intended for cementless use in total or partial hip arthroplasty and in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia.
- · 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.
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 Devi e Evaluation (ODE)
Asnt
ﺘﺮ
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIZIOII 510(k) Number .
AMIStem and Quadra - Line Extension 510(k) March 30, 2012
Section 4 - Page 2 of 2