(57 days)
Not Found
No
The summary describes a mechanical hip prosthesis and its material properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a hip prosthesis, which is designed to replace a diseased or damaged hip joint and restore function, thereby providing a therapeutic benefit to the patient.
No
The device description clearly states an "intended use" as a hip prosthesis for hip arthroplasty, and the indications for use are clinical conditions requiring hip replacement. There is no mention of it being used to diagnose conditions.
No
The device description clearly states it is a hip prosthesis made of titanium alloy, which is a physical hardware component, not software.
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 total or partial hip arthroplasty. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical implant made of titanium alloy, designed to replace a hip joint. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on mechanical properties (fatigue testing, range of motion) and biocompatibility (pyrogenicity), which are relevant for surgical implants, not IVDs.
Therefore, the MasterLoc™ hip prosthesis is a surgical implant, 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, 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)
LZO, MEH, KWY, LPH, LZY
Device Description
The MasterLoc™ Stem: Lateralized Plus implants are a line extension to Medacta's MasterLoc Stem product line (cleared under K151531 and K160289). The MasterLoc "" Stem: Lateralized Plus implants offer an additional caput-collum-diaphyseal (CCD) angle of 122° and neck offsets for various patient anatomies. The MasterLoc™ Stem: Lateralized Plus implants include cementless, flat, dual tapered design stems intended for total hip arthroplasty in primary or revision surgery.
The MasterLoc™ Stem: Lateralized Plus implants are made with a titanium alloy substrate (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery -Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy. The surface treatment consists of Ti coating with a thickness of 700 um in the proximal 2/3 of the shaft to improve proximal fixation. The distal portion of the stems are uncoated with a satin finish obtained from glass bead blasting.
The MasterLoc " Stem: Lateralized Plus implants are available in sizes 4 to 12, with a range of stem lengths from 126.5 mm to 147.5 mm. The stems have a Eurocone (12/14 taper with an angle of 5° 42' 30'') and the necks are polished.
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
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 Tests:
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants o Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants:
- fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including AMENDMENT 1 (2016)]; and
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components.
- Pyrogenicity:
- O the Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the pyrogen test according to USP chapter for pyrogenicity determination; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. o
Clinical Studies:
- no clinical studies were conducted.
Key results: Based on the information, the MasterLoc "Stem: Lateralized Plus can be considered substantially equivalent to the identified predicate devices.
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.
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
December 7, 2017
Image /page/0/Picture/1 description: The image shows 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.
Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K173267
Trade/Device Name: MasterLoc™ Stem: Lateralized Plus 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, KWY, LPH, LZY Dated: October 10, 2017 Received: October 11, 2017
Dear Ms. Rose:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MasterLoc™ Stem: Lateralized Plus
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, 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
3.0 510(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 Affairs Manager, Medacta International SA Consultant: Elizabeth Rose, Regulatory Affairs Manager, Medical Devices, Mapi USA, Inc. Date Prepared: October 10, 2017 Revised: November 29, 2017
II. Device
| Device Proprietary Name: | MasterLoc™ Stem: Lateralized Plus |
|---|---|
| Common or Usual Name: | Total Hip Prosthesis |
| Classification Name: | Hip joint metal/polymer semi-constrained cemented or |
| nonporous uncemented prosthesis | |
| FDA Product Code: | LZO, MEH, KWY, LPH, LZY |
| Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3358, 21 |
| CFR 888.3360 | |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices: Primary Predicate:
- MasterLoc™ Stem, K151531, Medacta International SA .
- MasterLoc™ Stem, K160289, Medacta International SA ●
Additional Predicates:
- Anthology Hip Stem, K052792, Smith & Nephew, Inc. ●
Device Description IV.
The MasterLoc™ Stem: Lateralized Plus implants are a line extension to Medacta's MasterLoc Stem product line (cleared under K151531 and K160289). The MasterLoc "" Stem: Lateralized Plus implants offer an additional caput-collum-diaphyseal (CCD) angle of 122° and neck offsets for various
4
patient anatomies. The MasterLoc™ Stem: Lateralized Plus implants include cementless, flat, dual tapered design stems intended for total hip arthroplasty in primary or revision surgery.
The MasterLoc™ Stem: Lateralized Plus implants are made with a titanium alloy substrate (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery -Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy. The surface treatment consists of Ti coating with a thickness of 700 um in the proximal 2/3 of the shaft to improve proximal fixation. The distal portion of the stems are uncoated with a satin finish obtained from glass bead blasting.
The MasterLoc " Stem: Lateralized Plus implants are available in sizes 4 to 12, with a range of stem lengths from 126.5 mm to 147.5 mm. The stems have a Eurocone (12/14 taper with an angle of 5° 42' 30'') and the necks are polished.
V. 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.
VI. Comparison of Technological Characteristics
The MasterLoc™ Stem: Lateralized Plus and the predicate devices share the following characteristics:
- . sizes:
- lengths;
- taper;
- substrate material;
- coating;
- device usage;
- sterility;
- shelf life; and
- packaging.
5
The MasterLoc" Stem: Lateralized Plus implants are technologically different from the predicate devices as follows:
- CCD angle, and
- neck offset.
VII. Performance Data
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in support of a substantial equivalence determination:
Non-Clinical Studies
- Performance Tests
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants o Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants:
- fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 4: Determination of Endurance Properties and Performance of Stemmed Femoral Components [Including AMENDMENT 1 (2016)]; and
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants for Surgery o Partial and Total Hip Joint Prostheses - Part 6: Determination of Endurance Properties of Head and Neck Region of Stemmed Femoral Components.
- Pyrogenicity
- O the Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the pyrogen test according to USP chapter for pyrogenicity determination; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. o
Clinical Studies
- no clinical studies were conducted.
VIII. Conclusion
Based on the above information, the MasterLoc ""Stem: Lateralized Plus can be considered substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design, and technological characteristics, as well as performance evaluations. The MasterLoc "Stem: Lateralized Plus implants are as safe and effective as the predicate devices, Medacta's MasterLoc " Stem (K151531 and K160289) and Smith & Nephew's Anthology Hip Stem (K052792).