(140 days)
No
The device description and performance studies focus on the mechanical properties and materials of a hip prosthesis, with no mention of AI or ML.
Yes.
The device is a hip prosthesis, which is used to replace a damaged hip joint and restore function, thereby treating the conditions listed in the indications for use.
No
This device is a hip prosthesis, which is an implant used for hip replacement surgery. Its purpose is to replace a diseased or damaged hip joint, not to diagnose a medical condition.
No
The device description clearly describes a physical hip prosthesis made of Titanium Aluminum Niobium Alloy with various coatings and design features, intended for surgical implantation. It is a hardware device, not software.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states that the MiniMAX is a hip prosthesis, which is an implantable device used to replace a damaged hip joint within the body.
- Intended Use: The intended use is for total or partial hip arthroplasty, which is a surgical procedure performed on the body.
The information provided describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The hip prosthesis MiniMAX 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 (comma separated list FDA assigned to the subject device)
LZO, MEH, KWY, LZY
Device Description
The purpose of this submission is to gain clearance for the new MiniMAX, which are anatomical HA coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.
The anatomical design of the MiniMAX stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is rounded and non-invasive. The MiniMAX stems' distal tip have a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.
MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).
MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300μm, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.
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)
Non-Clinical Studies:
- Performance Tests
- o Range of Motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants -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)]
- 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
- Static Fatigue Testing: ISO 7206-10:2003 Implants for Surgery -- Partial and o Total Hip-Joint Prostheses -- Part 10: Determination of Resistance To Static Load of Modular Femoral Heads
- Pull Off Force Testing: ASTM F2009-00 (Reapproved 2011) Standard Test o Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
- Coating Tests
- o Coating characterization testing was performed.
- 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.
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
- No clinical studies were conducted.
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.
K072857, K080885, K103721, K111145, K073337, K112115, K131518
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring three human profiles in a row.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medacta International SA % Ms. Elizabeth Rose Manager, Regulatory Affairs Mapi USA. Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
August 8, 2017
Re: K170845
Trade/Device Name: MiniMAX 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, LZY Dated: July 10, 2017 Received: July 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
1
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 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/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MiniMAX
Indications for Use (Describe)
The hip prosthesis MiniMAX 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)
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
Consultant: Elizabeth Rose, Regulatory Affairs, Manager, Medical Devices, Mapi USA, Inc. Date Prepared: March 21, 2017 Date Revised: August 4, 2017
II. Device
| Device Proprietary Name: | MiniMAX |
|---|---|
| Common or Usual Name: | Hip Prosthesis |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented |
| FDA Product Code(s): | LZO, MEH, KWY, LZY |
| Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3360 |
| Device Classification | 2 |
III. Predicate Device
Substantial equivalence is claimed to the following devices: Primary Predicate:
-
ABG III Monolithic Hip Stem (Also known as Anato Hip Stem), K123604, Howmedica 0 Osteonics Corp.
Additional Predicates -
MasterLoc Stem, K151531, Medacta International SA ●
IV. Device Description
The purpose of this submission is to gain clearance for the new MiniMAX, which are anatomical HA coated cementless stems intended to be used in total or partial hip arthroplasty in primary or revision surgery.
The anatomical design of the MiniMAX stems results in a 9° anteversion of the neck which is mirror polished with 12/14 Eurocone taper and a 127° neck-shaft angle. The macrostructures are negative medially and positive laterally which increases the contact area. The lateral flare is
4
MiniMAX Traditional 510(k)
rounded and non-invasive. The MiniMAX stems' distal tip have a 5° curvature to follow the contours of the femoral canal to aid in the insertion and avoiding distal interference.
MiniMAX stems can be combined with the CoCr ball heads (K072857, K080885 and K103721), Endo Head (K111145) or with the MectaCer BIOLOX® Forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).
MiniMAX stems are made of Titanium Aluminum Niobium Alloy (Ti-6Al-7Nb). The surface treatment consists of titanium plasma spray coating, Ra 300μm, in the proximal 2/3 of the shaft to improve proximal fixation and HA (Hydroxyapatite) coating, Ra 80um, along the entire length of the shaft.
MiniMAX stems are similar to predicate devices Howmedica Osteonics' ABG III Monolithic Hip Stem (K123604) and Medacta's MasterLoc Stem (K151531).
V. Indications for Use
The hip prosthesis MiniMAX 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
MiniMAX and the predicate devices share the following characteristics:
- indications for use; ●
- materials;
- design;
- sterile;
- coating;
- device usage; and ●
- taper.
MiniMAX is technologically different from the predicate devices as follows:
- lengths; and ●
- . neck angles.
The MiniMAX stems are manufactured with Titanium Niobium Alloy (Ti6-Al 7-Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials
5
MiniMAX Traditional 510(k)
- Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy with a Titanium Y367 + Hydroxyapatite "Osprovit"" coating.
Due to the extensive history of safe use in legally US-marketed medical devices, currently marketed devices made of the same material (Titanium Niobium Alloy (Ti6-Al 7-Nb) per ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy) with the same coating following recognized standards and following identical or similar manufacturing processes, additional biocompatibility testing was deemed unnecessary.
Discussion
As seen above, the technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. MiniMAX is the same or similar to the predicate devices in terms of intended use, materials of construction, design, coating, taper, device usage, and sterility. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of MiniMAX to the identified predicate devices.
VII. Performance Data
The following mechanical tests are being provided in support of a substantial equivalence determination. Based on the risk analysis, testing was conducted to written protocols with acceptance criteria that were based on standards and FDA guidance documents.
Non-Clinical Studies
- Performance Tests
- o Range of Motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants -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)]
- 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
- Static Fatigue Testing: ISO 7206-10:2003 Implants for Surgery -- Partial and o Total Hip-Joint Prostheses -- Part 10: Determination of Resistance To Static Load of Modular Femoral Heads
- Pull Off Force Testing: ASTM F2009-00 (Reapproved 2011) Standard Test o Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
6
MiniMAX Traditional 510(k)
- Coating Tests
- o Coating characterization testing was performed.
- 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.
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
Clinical Studies
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that MiniMAX is as safe and effective as the predicate devices. Therefore, it is concluded that MiniMAX is substantially equivalent to the predicate devices.
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