(107 days)
No
The document describes a mechanical hip prosthesis and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing according to ISO standards.
Yes.
The device, a hip prosthesis, is used to treat painful and/or disabled joints, avascular necrosis, and fractures, which are medical conditions, thereby providing therapy.
No
This device is a hip prosthesis, which is an implant used for hip replacement surgery. Its purpose is to replace a damaged hip joint, not to diagnose a medical condition.
No
The device description clearly states it is a hip prosthesis consisting of physical components like a femoral stem, femoral head, and acetabular components made of metal and polyethylene. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a hip prosthesis designed for surgical implantation in the human body to replace a damaged hip joint. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details the physical components of a hip prosthesis (femoral stem, head, acetabular components) which are implanted during surgery. IVD devices are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples, analyze biomarkers, or provide diagnostic information based on in vitro analysis.
Therefore, the MasterLoc® hip prosthesis is a medical device, but it falls under the category of an implantable orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The hip prosthesis MasterLoc® is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Product codes
LZO, MEH, LPH, KWY, LZY
Device Description
A hip prosthesis consists of a femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The acetabular components consists of a metal cup, and a liner that is made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components can be: Versafitcup, Versafitcup CC Trio, Mpact, Medacta Bipolar Head.
All the auxiliary components of the prosthesis are supplied in single-use individual packages.
The MasterLoo® stems can be combined with the CoCr ball heads, Endo Head or with the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads. Refer to the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads package insert and to CoCr heads package insert for more information about ball heads.
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
The modification to the device system to include the additional sizes of the MasterLoc Stem was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system.
The additional MasterLoc Stem sizes were compared to the worst case predicate device in accordance ISO 7206- 4:2010 (size 1 LAT with an XL ball head), while for ISO 7206-6:2013 the worst case remained the previous device already tested (size 12 LAT). The new test successfully met acceptance criteria.
The subject MasterLoc Stems have similar performance testing as the predicate in terms of:
RISK: Risk of breakage of highly stressed parts of the stem; STANDARD: ISO 7206-4 (2010), ISO 7206-6 (2013)
RISK: Limited ROM; STANDARD: EN ISO 21535 (2009)
RISK: Risk of implant loosening due to a low strength of the adhesion and durability of the coating.; STANDARD: Internal
RISK: Instability of the modular connection; STANDARD: ASTM F2009-00 (2009)
RISK: Instability of the modular connection; STANDARD: ASTM F2009-00 (2009)
RISK: Risk of inadequate selection of predicate device.; STANDARD: Internal
RISK: Risk of instability. Risk of bone breakage due to lateral opening.; STANDARD: Internal
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Medacta International SA % Ms. Roshana Ahmed, MA, RAC Sr. Manager, Regulatory Affairs - Medical Devices Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K160289 Trade/Device Name: MasterLoc Stem 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, LPH, KWY, LZY Dated: March 24, 2016 Received: March 24, 2016
Dear Ms. Roshana Ahmed:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
MasterLoc Stem
Indications for Use (Describe)
The hip prosthesis MasterLoc® is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services(301) 443-6740
3
Image /page/3/Picture/0 description: The image shows the logo for Medacta International. The logo consists of two blue triangles, the word "Medacta" in blue, a yellow line, and the word "International" in black. There is also a Swiss flag in the bottom right corner.
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: Stefano Baj, Regulatory Affairs Manager
- March 21, 2016 Date Prepared:
Device Information
Trade/Proprietary Name: MasterLoc Stem Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulation Number: 21 CFR 888.3353 Device Class: Class II Classification Product Code: LZO Subsequent Product Codes: LPH, MEH, KWY, LZY
Predicate Device:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K151531 | MasterLoc Stem | Medacta International | 10/30/15 |
4
Product Description
A hip prosthesis consists of a femoral stem made of metal, a modular femoral head made of metal or ceramic, and acetabular components. The acetabular components consists of a metal cup, and a liner that is made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components can be: Versafitcup, Versafitcup CC Trio, Mpact, Medacta Bipolar Head.
All the auxiliary components of the prosthesis are supplied in single-use individual packages.
The MasterLoo® stems can be combined with the CoCr ball heads, Endo Head or with the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads. Refer to the MectaCer BIOLOX® forte or MectaCer BIOLOX® delta femoral heads package insert and to CoCr heads package insert for more information about ball heads.
Indications for Use
The hip prosthesis MasterLoc® is designed for cementless use in total or partial hip arthroplasty 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.
Comparison to Predicate Devices
The indications for use, design features and materials of the MasterLoc Stem are substantially equivalent to those of the predicate device. The substantial equivalence of the MasterLoc Stem is adequately supported by the information and analysis data provided within this Premarket Notification.
Purpose of Special 510(k)
The purpose of this Traditional 510(k) is to obtain clearance of MasterLoc sizes 1 – 3 using K151531 (MasterLoc sizes 4-12) as a predicate device.
5
Performance Testing
The modification to the device system to include the additional sizes of the MasterLoc Stem was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system.
The additional MasterLoc Stem sizes were compared to the worst case predicate device in accordance ISO 7206- 4:2010 (size 1 LAT with an XL ball head), while for ISO 7206-6:2013 the worst case remained the previous device already tested (size 12 LAT). The new test successfully met acceptance criteria.
The subject MasterLoc Stems have similar performance testing as the predicate in terms of:
| RISK | STANDARD |
|---|---|
| Risk of breakage of highly stressed parts of the stem | ISO 7206-4 (2010) |
| ISO 7206-6 (2013) | |
| Limited ROM | EN ISO 21535 |
| (2009) | |
| Risk of implant loosening due to a low strength of the adhesion | |
| and durability of the coating. | Internal |
| Instability of the modular connection | ASTM F2009-00 |
| (2009) | |
| Instability of the modular connection | ASTM F2009-00 |
| (2009) | |
| Risk of inadequate selection of predicate device. | Internal |
| Risk of instability. Risk of bone breakage due to lateral opening. | Internal |
Section 5 - Page 4 of 5
6
Conclusion:
Based on the above information, the MasterLoc Stem can be considered as substantially equivalent to its predicate devices.