(144 days)
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No
The document describes a standard hip prosthesis and its mechanical testing, with no mention of AI or ML in its design, function, or testing.
Yes
A therapeutic device is one that treats or alleviates a medical condition. This hip prosthesis replaces a damaged hip joint to relieve pain and improve function, which are therapeutic actions.
No
Explanation: The device is a hip prosthesis, which is an implantable medical device used to replace a damaged hip joint. Its intended use is for surgical replacement, not for diagnosing conditions.
No
The device description explicitly details physical components made of metal, ceramic, and polyethylene, which are hardware. The performance studies also focus on mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. These tests are performed outside of the body.
- Device Description: The provided text describes a hip prosthesis, which is an implantable medical device designed to replace a damaged hip joint within the body.
- Intended Use: The intended use clearly states it's for "cementless use in total or partial hip arthroplasty in primary or revision surgery," which is a surgical procedure performed on the body.
The device is a surgical implant, not a diagnostic test performed on samples.
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, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, MEH, 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 MasterLoc® 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MasterLoc Stem was tested as part of design verification to written protocols with pre-defined acceptance criteria. The MasterLoc Stem was tested using the worst-case component size and option/design for each of the following:
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
A review of the mechanical data indicates that the performance of the MasterLoc Stem is substantially equivalent to the predicate devices and is capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K052792 ANTHOLOGY Hip Stem, K072857 Medacta Total Hip Prosthesis
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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing to the right, layered on top of each other. The profiles are meant to symbolize the department's focus on people and their well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Medacta International % Mr. Michael G. Loiterman, MPD, RAC, CCEP Director - Quality, Regulatory and Compliance Medacta USA 1556 West Carroll Ave. Chicago, Illinois 60607
Re: K151531 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, LPH, MEH, KWY, LZY Dated: October 5, 2015 Received: October 7, 2015
Dear Mr. Loiterman:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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/Resourcesfor You/Industry/default.htm. 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 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
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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) K151531
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, internal fixation, arthrodesis, surface replacement
arthroplasty, or total hip replacement.
Type of Use (Select one or both, as applicable)
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)
Prescription Use (Part 21 CFR 801 Subpart D)
PSC Publishing Services(301) 443-6740
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Image /page/3/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in blue, with two blue triangles above it. Below the word "Medacta" is a thin yellow line. Below the line is the word "International" in a smaller font, and to the right of the word is a red and white Swiss flag.
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. Michael G. Loiterman Director - Quality, Regulatory and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: 847-283-7931 Fax: 847-283-7695 Email: mloiterman@medacta.us.com
June 5, 2015 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
Primary Predicate Device:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K052792 | ANTHOLOGY Hip Stem | Smith & Nephew, Inc. | 10/7/05 |
Additional Predicate Device:
| 510(k) | Product | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K072857 | Medacta Total Hip Prosthesis | Medacta International | 2/4/08 |
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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 MasterLoc® 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, materials of the MasterLoc Stem are substantially equivalent to those of the predicate devices. The substantial equivalence of the MasterLoc Stem implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.
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Performance Testing
The MasterLoc Stem was tested as part of design verification to written protocols with pre-defined acceptance criteria. The MasterLoc Stem was tested using the worst-case component size and option/design for each of the following:
| 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 |
A review of the mechanical data indicates that the performance of the MasterLoc Stem is substantially equivalent to the predicate devices and is capable of withstanding expected in vivo loading without failure.
Conclusion:
Based on the above information, the MasterLoc Stem can be considered as substantially equivalent to its predicate devices.