(282 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for hip replacement and bone defect repair. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical components and their mechanical properties.
No.
The device is a modular hip replacement system intended for surgical replacement of the hip joint and major bone defects, not a therapeutic device in the sense of actively treating or healing disease.
No
The device is a modular hip replacement system intended for surgical replacement of the hip joint and addressing bone defects, not for diagnosing medical conditions.
No
The device description clearly states it is a "modular hip replacement system" and "femoral stems," which are physical implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that this is a "modular hip replacement system" intended for "total hip arthroplasty or hemiarthroplasty" to replace the hip joint and address bone defects. This is a surgical implant, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Keywords: The text does not mention any terms related to diagnostic testing, samples, analysis of biological materials, or disease detection through laboratory methods.
Therefore, the MUTARS® Proximal Femur Replacement System is a surgical implant, not an in vitro diagnostic device.
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 for cemented use in total hip arthroplasty or hemiarthroplasty 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 the prosthesis is generally only indicated in skeletally mature patients.
Product codes
MEH, LZO, KWY
Device Description
The purpose of this Traditional 510(k) is to expand the MUTARS® Proximal Femur System with a line extension to the existing cementless femoral stems. The new stems are intended for cemented applications.
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
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)
All necessary testing has been performed for the worst-case MUTARS® Cemented Femoral Stems to assure substantial equivalence to its predicate and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of the finished device. The following testing was conducted to characterize the devices:
- Distal Stem Fatigue Testing (ISO 7206-4)
- Particle Analysis
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MUTARS® Proximal Femur System (K181778)
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.
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October 16, 2020
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.
implantcast, GmbH % Lindsay Kleinwaks Associate, Regulatory Affairs Mcra, LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20005
Re: K200045
Trade/Device Name: MUTARS Cemented Femoral Stems 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, KWY Dated: September 16, 2020 Received: September 16, 2020
Dear Lindsay Kleinwaks:
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi, M.S. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200045
Device Name MUTARS® Cemented Femoral Stems
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 for cemented use in total hip arthroplasty or hemiarthroplasty 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 the prosthesis is generally only indicated in skeletally mature patients.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 201 Subpart D)☐ Over-The-Counter Use (21 CFR 201 Subpart C) | ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|---|---|
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) | |||
| ☐ Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(K) SUMMARY
| 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: | Lindsay Kleinwaks, Ph.D.
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5833
lkleinwaks@mcra.com |
| Date Prepared: | January 8, 2019 |
| Device Trade Name: | MUTARS® Cemented Femoral Stem |
| Device Class and
Common Name: | Class II, Femoral Stem |
| Classification: | 21 CFR §888.3353, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
21 CFR §888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis – Class II |
| Product Codes: | MEH, LZO, KWY |
| 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 for cemented
and uncemented use in total hip arthroplasty or hemiarthroplasty 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 the prosthesis is generally only indicated in skeletally mature
patients. |
| Device Description: | The purpose of this Traditional 510(k) is to expand the MUTARS®
Proximal Femur System with a line extension to the existing
cementless femoral stems. The new stems are intended for
cemented applications. |
| Predicate Devices: | MUTARS® Proximal Femur System (K181778) |
| Substantial
Equivalence: | The MUTARS® Cemented Femoral Stems are substantially
equivalent to the predicate device system, the MUTARS® Proximal
Femur Replacement System with respect to intended use and
design. |
| Performance Testing: | All necessary testing has been performed for the worst-case
MUTARS® Cemented Femoral Stems to assure substantial
equivalence to its predicate and to demonstrate the subject devices
perform as intended. All testing was performed on test units
representative of the finished device. The following testing was
conducted to characterize the devices: - Distal Stem Fatigue Testing (ISO 7206-4)
- Particle Analysis |
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Conclusions: The MUTARS® Cemented Femoral Stems possess the same intended use and technological characteristics as the predicate device. As such, the MUTARS® Cemented Femoral Stems are substantially equivalent for the intended use.