(69 days)
The EcoFit® hip stems are intended to be used in total hip arthroplasty for the following indications:
- 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® hip stems are intended for uncemented, press-fit fixation.
The EcoFit® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head 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.
The purpose of this Traditional 510(k) is to expand the EcoFit® Hip System with a line extension to the existing EcoFit® short stems cementless cpTi. The new EcoFit® short stems cementless cpTi are available in two different sizes 16.25 mm and in both standard and lateralized offset versions. The new EcoFit® short stems cementless cpTi included in the subject 510(k) are intermediate sizes, as compared to the EcoFit® short stems cementless cpTi predicate devices
This FDA 510(k) summary is for a medical device, specifically hip stems, and therefore does not involve AI/ML performance testing with acceptance criteria in the same way an AI/ML software would. The "acceptance criteria" here refer to meeting established and recognized standards for mechanical and material performance of an implantable device to demonstrate substantial equivalence to a predicate device.
Here's an interpretation based on the provided document and the typical requirements for non-software medical devices:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Summary) |
|---|---|
| Fatigue Strength | Demonstrated compliance with ISO 7206-4 and ISO 7206-6. |
| Range of Motion (ROM) Evaluation | No new worst-cases introduced and device performs as intended. |
| Impingement Testing | Demonstrated compliance with ASTM F2582. |
| Taper Disassembly Testing | Demonstrated compliance with ASTM F2009. |
| Fretting Corrosion Evaluation | Performed and deemed acceptable. |
| Coating Characterization | Performed and deemed acceptable. |
Note: The document doesn't provide specific numerical results or thresholds for "acceptance criteria" within these tests. Instead, it indicates that the device met the requirements of the cited standards, which inherently defines the acceptance criteria for each test.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "test units representative of the finished device" but does not specify the exact number of samples used for each test. In mechanical testing of medical devices, sample sizes are typically determined by relevant standards (e.g., ISO, ASTM) and statistical considerations to ensure sufficient power to detect failures or demonstrate compliance.
- Data Provenance: The testing was performed on physical devices (EcoFit® short stem cementless cpTi). The document does not specify the country of origin of the data beyond the manufacturer being implantcast GmbH, located in Germany. These are likely prospective tests conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is typically not relevant or included in a 510(k) summary for a mechanical device like a hip stem. "Ground truth" in this context refers to the physical properties and performance measured by standardized tests, rather than expert interpretation of clinical data. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against the established standards. Their qualifications would include expertise in mechanical testing, biomaterials, and relevant ISO/ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where human expert disagreement needs to be resolved to establish ground truth. For physical device testing, the results are objective measurements from laboratory equipment, and interpretation is against predefined engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. MRMC studies are used for evaluating diagnostic software or AI systems, particularly for image interpretation. This submission is for a physical orthopedic implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on established engineering and material science standards (e.g., ISO 7206, ASTM F2582, ASTM F2009). The tests measure objective physical properties and responses of the hip stem under defined conditions. Compliance with these standards indicates the device possesses the necessary mechanical and material properties for its intended use.
8. The sample size for the training set:
Not applicable. "Training set" refers to data used to train AI/ML algorithms. This is a physical medical device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 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.
June 3, 2024
implantcast GmbH % Dave McGurl Vice President, Regulatory Affairs - Orthopedics MCRA, LLC 803 7th St NW, Floor 3 Washington, District of Columbia 20001
Re: K240834
Trade/Device Name: EcoFit® short stem cementless cpTi 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, OOI Dated: March 26, 2024 Received: March 26, 2024
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 (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/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.
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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 820.30 and 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.
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-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).
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Sincerely,
Limin Sùn -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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
EcoFit® short stem cementless cpTi
Indications for Use (Describe)
The EcoFit® hip stems are intended to be used in total hip arthroplasty for the following indications: - 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® hip stems are intended for uncemented, press-fit fixation.
The EcoFit® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head 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)
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the logo for Implantcast. The logo consists of a green four-leaf clover shape with the letters "i" and "c" in the center. The word "implantcast" is written in green and yellow letters below the clover shape.
510(k) Summary
| Device Trade Name: | EcoFit® short stem cementless cpTi |
|---|---|
| Common Name: | Hip Stems and Associated Surgical Instruments |
| Manufacturer: | implantcast GmbHLüneburger Schanze 2621614 BuxtehudeGermany |
| Contact: | Ms. Juliane HoeppnerPhone: +49 4146 744-135j.hoeppner@implantcast.de |
| Prepared by: | Mr. Dave McGurlMCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5800dmcgurl@mcra.com |
| Date Prepared: | May 28, 2024 |
| Classifications: | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Class: | II |
| Product Codes: | LZO, KWY, OQI |
| Predicate Devices: | EcoFit® Hip System (K163577, K203420, K191569, K180263) |
Indications For Use:
The EcoFit® hip stems are intended to be used in total hip arthroplasty for the following indications:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis;
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Image /page/5/Picture/1 description: The image shows the logo for Implantcast. The logo features a green clover-like shape with the letters "iC" in the center, with the "i" being green and the "C" being yellow. Below the clover is the word "implantcast" in green, with the "cast" portion outlined in yellow.
- 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® hip stems are intended for uncemented, press-fit fixation.
The EcoFit® hip stems are intended to be used in partial (hemi) hip arthroplasty in conjunction with the ic-Bipolar Head 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 EcoFit® Hip System with a line extension to the existing EcoFit® short stems cementless cpTi. The new EcoFit® short stems cementless cpTi are available in two different sizes 16.25 mm and in both standard and lateralized offset versions. The new EcoFit® short stems cementless cpTi included in the subject 510(k) are intermediate sizes, as compared to the EcoFit® short stems cementless cpTi predicate devices
Substantial Equivalence:
The EcoFit® short stems cementless cpTi are substantially equivalent to the EcoFit® short stems cementless cpTi of the predicate device system, EcoFit® Hip System, cited on the previous page with respect to the intended use, design, and materials.
Performance Testing Summary:
All necessary testing has been performed for the worst-case configuration of the EcoFit® Hip System to demonstrate that no new worst-cases were introduced for the subject EcoFit® Short Stems cementless cpTi and 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 Strength Testing (ISO 7206-4 & ISO 7206-6) ●
- Range of Motion (ROM) Evaluation
- Impingement Testing (ASTM F2582) ●
- Taper Disassembly Testing (ASTM F2009) ●
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Image /page/6/Picture/0 description: The image shows the logo for Implantcast. The logo consists of a green clover-shaped design with the letters "ic" in the center, with the "c" being yellow. Below the clover is the word "implantcast" in green, with the "cast" portion being yellow.
- Fretting Corrosion Evaluation ●
- Coating Characterization ●
Conclusion:
The subject device and the EcoFit® short stems cementless cpTi of the predicate device system have the same intended use and technological characteristics.. Therefore, the EcoFit® short stems cementless cpTi are substantially equivalent to the predicate devices for the intended use.
§ 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.