(59 days)
No
The summary describes a passive implantable device (femoral cones) used for bone reconstruction in knee arthroplasty. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The manufacturing process (EBM) and testing methods are standard for medical implants and do not involve AI/ML.
No
This device is a sterile implantable device intended to fill and reconstruct bone deficiencies during knee arthroplasty procedures, which is a reconstructive structural component, not a therapeutic device.
No
Explanation: The device is an implantable medical device (femoral cone) used in knee replacement surgery to fill bone deficiencies, not to diagnose medical conditions.
No
The device is a physical implantable device made of titanium alloy, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The 3DMetal Femoral Cones are described as sterile, implantable devices intended to be used within the body during surgery to fill bone deficiencies.
- Intended Use: The intended use is for surgical implantation in the femur during knee replacement procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The 3DMetal Femoral Cones are indicated for use with Revision and GMK Hinge knee systems, as well as the GMK femoral extension stems and offsets. Specific indications are as follows:
-Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis,
rheumatoid arthritis or polyarthritis.
-Post traumatic loss of joint configuration.
-Considerable loss of function of the knee joint.
-High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
-Primary implantation failure.
-Former revision arthroplasty.
Product codes
JWH
Device Description
The 3DMetal Diaphyseal Femoral Cones are sterile implantable devices intended to be used in the diaphyseal side of the femoral component in order to fill and reconstruct large bone deficiencies and cavitary defects in the diaphysis of the distal femur. The subject devices are available in four different sizes and they are to be cemented to the extension stem used in GMK Revision and GMK Hinge systems in Total Knee Arthroplasty procedures. Analogously to the reference devices, the 3DMetal Diaphyseal Femoral Cones are manufactured using Electron Beam Melting (EBM) process with titanium alloy powder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Diaphysis of the distal femur (for use with knee systems)
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:
- DESIGN VALIDATION.
- o 3DMetal Diaphyseal Femoral Cones Design Rationale Shape, Dimension and Range of Product. Test Report B2 + Addendum.
- CHARACTERIZATION TESTING o
- o 3DMetal Diaphyseal Femoral Cones Dynamic Fatigue Test according to IL 07.09.5173 rev.0 and Report 00812-009932-1. Test report B1
- o 3DMetal Diaphyseal Femoral Cones Stereological evaluation according to ASTM F1854-15 and Test Report 00812-009932-2. Test report B3
- o PYROGENICITY:
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- 0 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
March 13, 2020
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K200075
Trade/Device Name: 3DMetal Diaphyseal Femoral Cones Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: January 13, 2020 Received: January 14, 2020
Dear Chris Lussier:
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 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,
Ting Song Acting 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) K200075
Device Name 3DMetal Diaphyseal Femoral Cones
Indications for Use (Describe)
The 3DMetal Femoral Cones are indicated for use with Revision and GMK Hinge knee systems, as well as the GMK femoral extension stems and offsets. Specific indications are as follows:
-Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis,
rheumatoid arthritis or polyarthritis.
-Post traumatic loss of joint configuration.
-Considerable loss of function of the knee joint.
-High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
-Primary implantation failure.
-Former revision arthroplasty.
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
2.0 510(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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: January 13, 2020
II. Device
| Device Proprietary Name: | 3DMetal Diaphyseal Femoral Cones |
|---|---|
| Common or Usual Name: | Total Knee Prosthesis |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- |
| constrained cemented prosthesis | |
| Primary Product Code: | JWH |
| Regulation Number: | 21 CFR 888.3560 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
-
Trabecular Metal™ Femoral Cone Augments, K103517, Zimmer Trabecular Metal A Technology, Inc
In addition, the following Reference device is cited within the submission: -
3DMetal Tibial Cones (K170149), Medacta International SA A
IV. Device Description
The 3DMetal Diaphyseal Femoral Cones are sterile implantable devices intended to be used in the diaphyseal side of the femoral component in order to fill and reconstruct large bone deficiencies and cavitary defects in the diaphysis of the distal femur.
4
The subject devices are available in four different sizes and they are to be cemented to the extension stem used in GMK Revision and GMK Hinge systems in Total Knee Arthroplasty procedures.
Analogously to the reference devices, the 3DMetal Diaphyseal Femoral Cones are manufactured using Electron Beam Melting (EBM) process with titanium alloy powder.
V. Indications for Use
The 3DMetal Femoral Cones are indicated for use with the GMK Revision and GMK Hinge knee systems, as well as the GMK femoral extension stems and offsets. Specific indications are as follows:
- Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, ● rheumatoid arthritis or polyarthritis.
- Post traumatic loss of joint configuration. ●
- Considerable loss of function of the knee joint. ●
- High-grade joint destruction requiring additional stabilization and reconstruction of ● bone defects.
- Primary implantation failure. ●
- Former revision arthroplasty.
VI. Comparison of Technological Characteristics
The 3DMetal Diaphyseal Femoral Cones and the predicate Trabecular Metal Femoral Cone Augments share the following characteristics:
- shape:
- porosity of trabecular layer;
- biocompatibility; ●
- device usage:
- sterility;
- shelf life; and ●
- packaging. ●
The 3DMetal Diaphyseal Femoral Cones differ from the predicate devices as follow:
- sizes
- material
Discussion
Medacta International SA has not made any change to the intended use, shape, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.
The slight difference in sizes between the subject and the predicate devices does not raise new question of safety or effectiveness as demonstrated by design validation testing.
The different material of the 3DMetal Diaphyseal Femoral Cones with respect to the predicate devices, do not compromise device safety and performance since the material of the subject
5
device, Ti6Al4V is commonly used for implantable medical devices. Additionally, the subject device material and manufacturing process are shared with the reference devices, 3DMetal Tibial Cones (K170149).
The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the 3DMetal Femoral Cones implants to the identified predicate devices.
Performance Data VII.
Based on the risk analysis, design validation and characterization testing were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION .
- o 3DMetal Diaphyseal Femoral Cones Design Rationale Shape, Dimension and Range of Product. Test Report B2 + Addendum.
- CHARACTERIZATION TESTING o
- o 3DMetal Diaphyseal Femoral Cones Dynamic Fatigue Test according to IL 07.09.5173 rev.0 and Report 00812-009932-1. Test report B1
- o 3DMetal Diaphyseal Femoral Cones Stereological evaluation according to ASTM F1854-15 and Test Report 00812-009932-2. Test report B3
- o PYROGENICITY:
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter )
- 0 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 the 3DMetal Diaphyseal Femoral Cones are as safe and effective as the predicate devices. Therefore, it is concluded that the 3DMetal Diaphyseal Femoral Cones are substantially equivalent to the predicate device.