(76 days)
Not Found
No
The summary describes a traditional hip replacement system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, the EcoFit® Hip System, is indicated for use as a total hip replacement to treat various conditions such as degenerative joint disease, rheumatoid arthritis, fractures, and for revision of failed hip arthroplasty, all of which are therapeutic interventions.
No
Explanation: The device is an EcoFit® Hip System, a total hip replacement system, and a MUTARS® Proximal Femur Replacement System, which are all orthopedic implants used for surgical replacement of hip joints or bones, not for diagnosing conditions.
No
The device description explicitly states it is a "line extension inclusive of additional acetabular inserts and cementless femoral stems," which are physical hardware components for hip replacement surgery. The performance studies also describe testing on physical units.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The descriptions clearly state the devices are intended for use as total hip replacements and proximal femur replacements in surgical procedures to treat various conditions affecting the hip joint. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description focuses on expanding a portfolio of acetabular inserts and cementless femoral stems, which are components of a hip implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a surgical implant used to replace or reconstruct parts of the hip joint.
N/A
Intended Use / Indications for Use
Acetabular Inserts
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
-
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
-
Revision of previously failed total hip arthroplasty.
The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
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 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.
Femoral Stems
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- Revision of previously failed total hip arthroplasty.
The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
The MUTARS® ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the EcoFit® Hip System and MUTARS® Proximal Femur Replacement System for the following indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY, OQI
Device Description
The purpose of this Traditional 510(k) is to expand the existing EcoFit® Hip System portfolio with a line extension inclusive of additional acetabular inserts and cementless femoral stems.
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
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)
All necessary testing has been performed for the "worst case" Performance Testing: components of the line extension of the EcoFit® Hip 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 the finished device. The following testing was conducted to characterize the devices:
- Fatigue Testing (ISO 7206-4 and ISO 7206-6) .
- Impingement Testing (ASTM F2582-14) ●
- Liner Disassembly Testing (ASTM F1820) ●
- Range of Motion
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
February 3, 2021
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, Spine Regulatory Affairs MCRA, LLC. 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K203420
Trade/Device Name: EcoFit® Hip 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: LZO, KWY, OQI Dated: November 19, 2020 Received: November 19, 2020
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
1
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 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 (QS) 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 medical devices and radiation-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 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
2
Indications for Use
510(k) Number (if known) K203420
Device Name EcoFit® Hip System
Indications for Use (Describe)
Acetabular Inserts
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
-
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
-
Revision of previously failed total hip arthroplasty.
The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
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 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.
Femoral Stems
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
-
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
-
Revision of previously failed total hip arthroplasty.
The EcoFit® Acetabular Cup is intended for uncemented, press-fit fixation.
The MUTARS® ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the EcoFit® Hip System and MUTARS® Proximal Femur Replacement System for the following indications:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
Rheumatoid arthritis
-
Correction of functional deformity
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
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)
3
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4
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: | Dave McGurl |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5797 | |
| dmcgurl@mcra.com | |
| Date Prepared: | November 17, 2020 |
| Device Trade Name: | EcoFit® Hip System |
| Device Class and | |
| Common Name: | Class II, Total Hip Replacement |
| Classification: | 21 CFR §888.3353, Hip joint metal/ceramic/polymer semi- |
| constrained cemented or nonporous uncemented prosthesis | |
| Product Codes: | LZO, KWY, OOI |
5
Indications for Use:
Acetabular Inserts
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis; l
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- -Revision of previously failed total hip arthroplasty.
The EcoFit® Acetabular Cup is intended for uncemented, pressfit fixation.
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 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.
Femoral Stems
The EcoFit® Hip System is indicated for use as a total hip replacement in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- -Rheumatoid arthritis;
- -Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- Revision of previously failed total hip arthroplasty. l
The EcoFit® Acetabular Cup is intended for uncemented, pressfit fixation.
6
| | The MUTARS® ic-Bipolar Head System is intended for
uncemented use in hemiarthroplasty, where the femoral head
requires replacement but the acetabulum does not, in
conjunction with the EcoFit® Hip System and MUTARS®
Proximal Femur Replacement System for the following
indications:
- Non-inflammatory degenerative joint disease including
osteoarthritis and avascular necrosis - Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and
trochanteric fractures of the proximal femur with head
involvement, unmanageable using other techniques. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The purpose of this Traditional 510(k) is to expand the existing
EcoFit® Hip System portfolio with a line extension inclusive of
additional acetabular inserts and cementless femoral stems. |
| Predicate Devices: | Primary Predicate: EcoFit® Hip System (K163577 and
K180263);
Zimmer Longevity IT Highly Crosslinked Polyethylene Elevated
Liners, Continuum Acetabular System, Trilogy Integrated Taper
(IT) Acetabular System (K101229) |
| Substantial
Equivalence: | This 510(k) is a line extension of the cleared EcoFit® Hip
System (K163577 and K180263). The line extension includes
additional acetabular cup inserts (4mm offset and 15° lip) and
two additional intermediate femoral stem sizes. The EcoFit® Hip
System acetabular liners and cementless femoral stems are
substantially equivalent to the components of the legally
marketed predicate device systems, the EcoFit® Hip System
with respect to intended use and design. |
7
- All necessary testing has been performed for the "worst case" Performance Testing: components of the line extension of the EcoFit® Hip 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 the finished device. The following testing was conducted to characterize the devices:
- Fatigue Testing (ISO 7206-4 and ISO 7206-6) .
- Impingement Testing (ASTM F2582-14) ●
- Liner Disassembly Testing (ASTM F1820) ●
- Range of Motion