(259 days)
Not Found
No
The 510(k) summary describes a mechanical implant (a hip replacement system) and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML. The testing described is mechanical fatigue testing.
Yes
The device is a hip replacement system intended for total hip arthroplasty or hemiarthroplasty to replace the hip joint and address major bone defects in cases like oncology and severe trauma. These procedures are therapeutic interventions designed to treat or alleviate a medical condition.
No
The device is a modular hip replacement system intended for surgical replacement of the hip joint and addressing bone defects, not for diagnosing conditions.
No
The device description clearly indicates it is a modular hip replacement system with physical components (femoral stems) and performance testing related to material fatigue, which are characteristics of a hardware medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the hip joint and addressing bone defects. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a modular hip replacement system with femoral stems. This aligns with a surgical implant, not a diagnostic device.
- Anatomical Site: The anatomical site is the proximal femur and hip joint, which are locations within the body where a surgical implant would be placed.
- Performance Studies: The performance study mentioned is "Distal Stem Fatigue Testing," which is relevant to the mechanical integrity of a surgical implant, not the analytical performance of a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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 this prosthesis is generally only indicated in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY
Device Description
The MUTARS® femoral stem cemented 160 mm and 200 mm are new stems that are available with longer lengths (160 and 200mm) and represent a line extension to the existing MUTARS® Cemented Femoral Stems and MUTARS® Proximal Femur Replacement System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal femur, Hip joint
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® femoral stem cemented 160 mm and 200 mm to assure substantial equivalence to the predicates 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 device:
- Distal Stem Fatigue Testing (ISO 7206-4)
Conclusions: The MUTARS® femoral stem cemented 160 mm and 200 mm subject to this submission possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the MUTARS® femoral stem cemented 160 mm and 200 mm is substantially equivalent to the predicate devices for the intended use.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 30, 2024
Implantcast, GmbH % Hannah Irwin Director, Regulatory Affairs MCRA, LLC 803 7th Street NW, Floor 3 Washington, District of Columbia 20001
Re: K240391
Trade/Device Name: MUTARS® femoral stem cemented 160 mm and 200 mm 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, KWY
Dear Hannah Irwin:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 24, 2024. Specifically, FDA is updating this SE Letter to include the additional product code KWY as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, Ph.D., OHT6: Office of Orthopedic Devices, at 301-796-7056 or Limin.Sun(@fda.hhs.gov.
Sincerely,
Limin Sun -S
Limin Sun, Ph.D. 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
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 24, 2024
Implantcast, GmbH % Hannah Irwin Director, Regulatory Affairs MCRA, LLC 803 7th Street NW, Floor 3 Washington, District of Columbia 20001
Re: K240391
Trade/Device Name: MUTARS® femoral stem cemented 160 mm and 200 mm 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 Dated: September 26, 2024 Received: September 25, 2024
Dear Hannah Irwin:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
3
assistance/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,
Limin Sun -S
Limin Sun, Ph.D. 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
4
Indications for Use
510(k) Number (if known) K240391
Device Name
MUTARS® femoral stem cemented 160 mm and 200 mm
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 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)
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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: | Ms. Hannah Irwin
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5820
hirwin@mcra.com |
| Date Prepared: | October 22, 2024 |
| Device Trade Name: | MUTARS® femoral stem cemented 160 mm and 200 mm |
| 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 |
| Product Codes: | LZO, KWY |
| Indications for Use: | The indications for use for the proposed MUTARS® femoral
stem cemented 160 mm and 200 mm are as follows:
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 this prosthesis is generally only indicated in
skeletally mature patients. |
| Device Description: | The purpose of this Traditional 510(k) is to expand the
MUTARS® Cemented Femoral Stems and MUTARS®
Proximal Femur Replacement System with a line extension to
the existing stems. The new stems are available with longer
lengths (160 and 200mm). |
| Primary Predicate
Device: | MUTARS® Cemented Femoral Stems (K200045) |
| Additional Predicate
Device: | MUTARS® Proximal Femur Replacement System
(K181778) |
| Substantial
Equivalence: | The MUTARS® femoral stem cemented 160 mm and 200
mm is substantially equivalent to the hip stems of the legally
marketed predicate device systems, the implantcast
MUTARS Cemented Femoral Stems and 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® femoral stem cemented 160 mm and 200 mm to
assure substantial equivalence to the predicates 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
device: |
6
7
- . Distal Stem Fatigue Testing (ISO 7206-4)
Conclusions: The MUTARS® femoral stem cemented 160 mm and 200 mm subject to this submission possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the MUTARS® femoral stem cemented 160 mm and 200 mm met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the MUTARS® femoral stem cemented 160 mm and 200 mm is substantially equivalent to the predicate devices for the intended use.