(28 days)
No
The 510(k) summary describes a line extension for a hip prosthesis system, focusing on material and size variations of components. There is no mention of AI, ML, or any software-driven features.
Yes
The device is a total hip prosthesis system, which is used to replace a joint and alleviate severe pain or disability, clearly indicating a therapeutic purpose.
No
Explanation: The device description indicates that this system is a hip prosthesis, which is an implantable device used for hip replacement surgery. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical components (femoral ball heads, femoral stems, acetabular cups and liners) which are hardware, 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 for hip replacement, addressing conditions like arthritis, avascular necrosis, and fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components of a hip prosthesis (femoral ball heads, stems, acetabular cups). These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used to diagnose diseases or conditions.
Therefore, the Medacta Total Hip Prosthesis System is a surgical implant, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
JDI
Device Description
The device modifications to the Medacta Total Hip Prosthesis System which are the subject of this special 510(k) are as follows:
Line Extension to include CoCrMo Femoral ball heads of 22 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System (K072857) and the Ortho Development's Triplus® Acetabular cups and liners.
Line Extension to include CoCrMo Femoral ball heads of 36 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System and the Ortho Development's Triplus® Acetabular cups and liners.
Labeling to allow the use of Medacta Quadra® S stems from Medacta Total Hip Prosthesis system and Medacta CoCrMo Femoral ball heads of sizes 22 and 28 mm with Ortho Development's Pivot Bipolar heads. The Ortho Development's Pivot Bipolar heads were previously cleared under K050966.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls.
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.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K0B0885 (pg 1/2)
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Special 510(k) Summary
APR 2 8 2008
MEDACTA International SA Manufacturer: Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX
Ms. Natalie J. Kennel Contact Person: 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 28, 2008 Date Prepared:
DEVICE INFORMATION
Trade/Proprietary Name: Medacta Total Hip Prosthesis System - Line Extension Hip Joint, metal/polymer/metal semi-Common/Classification Name: constrained cemented prosthesis
21 CFR 888.3350 Class II Device Product Code: JDI
Predicate Devices:
The Medacta Total Hip Prosthesis - Line Extensions are substantially equivalent to the Medacta Total Hip Prosthesis System cleared under K072857 on Feb. 4, 2008.
Product Modification:
The device modifications to the Medacta Total Hip Prosthesis System which are the subject of this special 510(k) are as follows:
Special 510(k) - Line Extension 510(k) March 28, 2008
Company Confidential Page 19 of 115
1
Line Extension to include CoCrMo Femoral ball heads of 22 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System (K072857) and the Ortho Development's Triplus® Acetabular cups and liners.
Line Extension to include CoCrMo Femoral ball heads of 36 mm diameter: These CoCrMo femoral ball heads would be used with Quadra® S femoral stems from the Medacta Total Hip Prosthesis System and the Ortho Development's Triplus® Acetabular cups and liners.
Labeling to allow the use of Medacta Quadra® S stems from Medacta Total Hip Prosthesis system and Medacta CoCrMo Femoral ball heads of sizes 22 and 28 mm with Ortho Development's Pivot Bipolar heads. The Ortho Development's Pivot Bipolar heads were previously cleared under K050966.
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.
The indications for use for the modified system remain the same as the original 510(k), K072857.
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act.
Risk analysis was conducted on the impact of these changes and appropriate design verification and validation was conducted under the company's design controls.
Conclusion:
The results from design controls and the information provided in this submission support the conclusion that the Medacta Total Hip Prosthesis System - Line Extensions are substantially equivalent to its predicate device, Medacta Total Hip Prosthesis System with respect to indications for use and technological characteristics.
Medacta Total Hip Special 510(k) - Line Extension March 28, 2008
Company Confidential Page 20 of 115
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDACTA International, SA % NJK & Associates, Inc. Ms. Natalie J. Kennel Consultant 13721 Via Tres Vista San Diego, CA 92129
APR 2 8 2008
Re: K080885
Trade/Device Name: Medacta Total Hip Prosthesis System - Line Extension Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: March 28, 2008 Received: March 31, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Natalie J. Kennel
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): KO800885 (pcg // /
Device Name: Medacta Total Hip Prosthesis System - 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 X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Nel re ogl
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page of
510(k) Number K080885