(265 days)
No
The summary describes a modular hip replacement system made of standard materials and tested using mechanical and material performance studies. There is no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The device is a hip replacement system intended for total hip arthroplasty, addressing conditions like oncology cases requiring radical resection and replacement of bone, and limb salvage procedures. These are therapeutic interventions aimed at restoring function and treating medical conditions.
No
This device is a modular hip replacement system intended for surgical implantation to replace the hip joint and address bone defects, which is a therapeutic rather than diagnostic function.
No
The device description explicitly lists physical components made of TiAls V4, such as the proximal femur, femoral stem, stem extension piece, connecting part, and screws, indicating it is a hardware device.
Based on the provided information, 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.
- Device Description and Intended Use: The description clearly states that the MUTARS® Proximal Femur Replacement System is a modular hip replacement system intended for surgical implantation to replace the hip joint and address bone defects. This is a surgically implanted device, not a device used for testing samples outside the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the MUTARS® Proximal Femur Replacement System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.
The MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty for the following indications:
- Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
- Limb salvage procedures including surgical intervention failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO
Device Description
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system, which combines the offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur Replacement System includes the MUTARS® Proximal Femur System. The MUTARS® Proximal Femur System is manufactured of TiAls V4 and includes the proximal femur, femoral stem, stem extension piece, connecting part, and screws. The MUTARS® Proximal Femur Replacement System can be used as a total hip system with previously cleared (K163577) modular cobalt chrome femoral head, Ecofit® uncemented titanium alloy acetabular cup and polyethylene liner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, proximal femur
Indicated Patient Age Range
skeletally mature patients
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)
All necessary testing has been performed for the worst-case configuration of the MUTARS® Proximal Femur Replacement System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the MUTARS® Proximal Femur Replacement System was characterized through the following tests:
- Construct fatigue ●
- Corrosion ●
- Range of Motion ●
- Modular Disassembly ●
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
§ 888.3353 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
March 25, 2019
Image /page/0/Picture/1 description: The image contains 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.
implantcast GmbH % Dave Mcgurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K181778
Trade/Device Name: MUTARS Proximal Femur Replacement System 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: MEH, LZO Dated: Julv 3. 2018 Received: July 3, 2018
Dear Dave Mcgurl:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.
Daniel S. Ramsey -S 2019.03.25 16:08:20 -04'00'
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
MUTARS® Proximal Femur Replacement System
Indications for Use (Describe)
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.
The MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty for the following indications:
- Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
- Limb salvage procedures including surgical intervention failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
| Device Trade Name: | MUTARS® Proximal Femur Replacement System |
|---|---|
| Manufacturer: | implantcast GmbH |
| Lueneburger Schanze 26 | |
| 21614 Buxtehude | |
| Germany | |
| Contact: | Ms. Juliane Höppner |
| Phone: +49 4161 744-135 | |
| Fax: +49 4161 744-200 | |
| j.hoeppner@implantcast.de | |
| Prepared by: | Mr. Dave McGurl |
| Director, Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5797 | |
| Fax: 202.552.5798 | |
| dmcgurl@mcra.com | |
| Date Prepared: | March 21, 2019 |
| Common Name: | Proximal Femur Replacement |
| Classification: | 21 CFR §888.3353 |
| 21 CFR §888.3390 | |
| Class: | II |
| Product Codes: | MEH, LZO, |
| Primary Predicate Device: | Stryker GMRS Proximal Femoral Replacement System (K965164, |
| K023087) | |
| Reference Predicate: | Ecofit Hip System (K163577) |
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Indications for Use:
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.
The MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty for the following indications:
- Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
- Limb salvage procedures including surgical intervention for severe trauma, failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.
Use of this prosthesis is generally only indicated in skeletally mature patients.
Device Description:
The MUTARS® Proximal Femur Replacement System is a modular hip replacement system, which combines the offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur Replacement System includes the MUTARS® Proximal Femur System. The MUTARS® Proximal Femur System is manufactured of TiAls V4 and includes the proximal femur, femoral stem, stem extension piece, connecting part, and screws. The MUTARS® Proximal Femur Replacement System can be used as a total hip system with previously cleared (K163577) modular cobalt chrome femoral head, Ecofit® uncemented titanium alloy acetabular cup and polyethylene liner.
Performance Testing:
All necessary testing has been performed for the worst-case configuration of the MUTARS® Proximal Femur Replacement System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of finished devices. The performance of the MUTARS® Proximal Femur Replacement System was characterized through the following tests:
- Construct fatigue ●
- Corrosion ●
- Range of Motion ●
- Modular Disassembly ●
Substantial Equivalence:
The MUTARS® Proximal Femur Replacement System is substantially equivalent with respect to materials, indications, function and performance to the Stryker GMRS Proximal Femoral Replacement System (K965164, K023087).