(279 days)
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® Hip Stem and EcoFit® Acetabular Cup are intended for uncemented, press-fit fixation.
The EcoFit® Hip System consists of EcoFit® femoral hip stems, modular Cobalt Chrome Molybdenum alloy femoral heads, and modular metal backed acetabular cups with ultra-high molecular weight polyethylene liners.
The EcoFit® femoral stem system includes three versions: the standard length stem and a Coxa Vara version. The EcoFit® femoral hip stem is collarless, straight, monoblock, flat tapered wedge design manufactured from TiAlsV4 alloy. The stem tapers from proximal to distal and is designed with a rectangular cross sectional geometry to provide rotational stability. A plasma sprayed coating of commercially pure titanium (cpTi) is applied to the proximal half of the stem. The modular femoral heads are manufactured from Cobalt Chrome Molybdenum alloy and attach to the femoral stem via a Morse style taper in a diameter of 32 mm in several neck lengths.
The EcoFit® Acetabular Cup is a two (2) piece modular cup consisting of a metal shell and a polyethylene liner. The metal shell is manufactured from TiAlsV4 alloy and a plasma sprayed coating of commercially pure titanium (cpTi) is applied to the metal shell. The polyethylene liner is manufactured from ultra-high molecular weight polyethylene and is available with an inner diameter of 32 mm for use with 32 mm outer diameter femoral head. The metal shell has a threaded insertion hole at the apex and the shell is available in two (2) versions, one with three (3) peripheral holes for the placement of bone screws as needed for adjunctive fixation and one without screw holes. A threaded apex hole plug is provided to fill the threaded insertion hole after shell placement while bone screw hole plugs are available to fill screw holes that are not used.
The EcoFit® hip stems and EcoFit® acetabular cups are intended for uncemented press-fit application.
The provided document describes a 510(k) premarket notification for the "EcoFit® Hip System" which is a total hip replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information provided heavily emphasizes non-clinical (bench) testing, and explicitly states that clinical testing was not necessary.
As a result, a direct answer to all the requested points regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/device performance study as traditionally understood is not available in this document. The device in question is a physical medical implant, not an AI or software device.
However, I can extract the acceptance criteria and performance results available for the non-clinical testing performed:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Metallic Bone Screw Test (Torsional Properties, Driving Torque, Pull-Out Strength) | Complies with ASTM F 543 | Acceptable |
| Liner Disassembly Acetabular Shell – Liner (Push-Out, Lever-Out, Torsionals Properties) | Complies with ASTM F 1820 | Acceptable |
| Taper disassembly (Axial Disassembly Force Head - Femoral Stem) | Complies with ASTM F 2009 | Acceptable |
| Impingement EcoFit® Cup – Stem | Complies with ASTM F 2582 | Acceptable |
| Fatigue Strength EcoFit® Hip Stem – Distal | Complies with ISO 7206-4 | Pass |
| Fatigue Strength EcoFit® Hip Stem - Proximal (Neck Region) | Complies with ISO 7206-6 | Pass |
| Fretting corrosion evaluation | No specific standard listed | Acceptable |
| ROM EcoFit® Hip Stem – EcoFit® Cup | Complies with ISO 21535 Annex A | Acceptable |
| Biocompatibility | Complies with ISO 10993 | Pass |
Explanation of "Acceptable Criteria (Implicit)": For most of the tests, the acceptance criteria are implicit in the listed ASTM or ISO standards. To understand the specific numerical or qualitative criteria, one would need to refer to those standards directly. The document states that the results were "Acceptable" or "Pass," indicating the device met the requirements of the respective standards.
Regarding the other requested information (points 2-9):
These points are primarily relevant for studies evaluating the performance of software, AI models, or diagnostics where a comparison against a "ground truth" established by experts is central. This document pertains to a physical medical device (hip implant) and its substantial equivalence to predicate devices through non-clinical (bench) testing. Therefore, the concepts of test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, and their ground truth establishment do not apply in the context of this 510(k) submission for the EcoFit® Hip System.
The "study" that proves the device meets acceptance criteria is the series of non-clinical, benchtop tests listed in the table. These tests confirm the mechanical properties, durability, and biocompatibility of the hip implant components according to established international and American standards. The successful completion of these tests, demonstrating comparable performance to predicate devices and meeting relevant standards, supported the FDA's determination of substantial equivalence.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Septemeber 25, 2017
implantcast GmbH % Dave McGurl Director, Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers LLC 1050 K Street NW, Suite 1000 Washington. District of Columbia 20001
Re: K163577 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 Dated: August 22, 2017 Received: August 22, 2017
Dear Mr. 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
EcoFit® Hip System
Indications for Use (Describe)
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® Hip Stem and EcoFit® Acetabular Cup are intended for uncemented, press-fit fixation.
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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510(k) Summary
| 510(k) SPONSOR: | implantcast GmbHLueneburger Schanze 2621614 BuxtehudeGermanyContact: Juliane HöppnerEmail: j.hoeppner@implantcast.deTelephone: +49 4161 744-135FAX: +49 4161 744-200 |
|---|---|
| TRADE NAME: | EcoFit® Hip System |
COMMON NAME: Total Hip Replacement
| Product | Regulation and Description | Description | Product Code | Device Class |
|---|---|---|---|---|
| EcoFit® Hip System | 21 CFR 888.3353 | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. | LZO | II |
PREDICATE DEVICES:
- Biomet Taperloc® Complete (K101086, K103755) .
- Zimmer® M/L Taper Hip Prosthesis (K032726) ●
- Biomet Taperloc® Complete Size 4mm and XR 123° (K120030) .
- Biomet Taperloc® Complete Microplasty System (K110400) .
- Zimmer Continuum™ and Trilogy® Integrated Taper (IT) Acetabular Systems . (K091508)
- . Aesculap Excia Total Hip System - Plasmacup SC (K042344) and Plasmacup NSC (K061699)
- . Theken Companies iNSitu Total Hip System (K161184)
- Smith & Nephew REFLECTION ACETABULAR COMPONENT (K932755, K022556) .
- Zimmer BIOLOX® Delta Ceramic Femoral Head (K071535, K130899) .
- . Zimmer VerSys® Fiber Hip Prosthesis (K061786, K964769)
- . Total Joint Orthopedics Klassic HD Hip System (K143407)
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DEVICE DESCRIPTION:
The EcoFit® Hip System consists of EcoFit® femoral hip stems, modular Cobalt Chrome Molybdenum alloy femoral heads, and modular metal backed acetabular cups with ultra-high molecular weight polyethylene liners.
The EcoFit® femoral stem system includes three versions: the standard length stem and a Coxa Vara version. The EcoFit® femoral hip stem is collarless, straight, monoblock, flat tapered wedge design manufactured from TiAlsV4 alloy. The stem tapers from proximal to distal and is designed with a rectangular cross sectional geometry to provide rotational stability. A plasma sprayed coating of commercially pure titanium (cpTi) is applied to the proximal half of the stem. The modular femoral heads are manufactured from Cobalt Chrome Molybdenum alloy and attach to the femoral stem via a Morse style taper in a diameter of 32 mm in several neck lengths.
The EcoFit® Acetabular Cup is a two (2) piece modular cup consisting of a metal shell and a polyethylene liner. The metal shell is manufactured from TiAlsV4 alloy and a plasma sprayed coating of commercially pure titanium (cpTi) is applied to the metal shell. The polyethylene liner is manufactured from ultra-high molecular weight polyethylene and is available with an inner diameter of 32 mm for use with 32 mm outer diameter femoral head. The metal shell has a threaded insertion hole at the apex and the shell is available in two (2) versions, one with three (3) peripheral holes for the placement of bone screws as needed for adjunctive fixation and one without screw holes. A threaded apex hole plug is provided to fill the threaded insertion hole after shell placement while bone screw hole plugs are available to fill screw holes that are not used.
The EcoFit® hip stems and EcoFit® acetabular cups are intended for uncemented press-fit application.
INTENDED USE AND INDICATIONS FOR USE:
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® Hip Stem and EcoFit® Acetabular Cup are intended for uncemented, press-fit fixation.
SUMMARY OF TECHNOLOGIES:
The EcoFit® Hip System is substantially equivalent to the previously cleared predicate devices based on similarities in intended use and indications, design features, materials, packaging and sterilization methods. Additionally, the EcoFit® Hip System is similar in fixation methods and comes in a similar range of sizes as the predicate devices.
NON-CLINICAL TESTING:
The following testing was performed to demonstrate substantial equivalency of the EcoFit® Hip System to the predicate devices. The results of the testing show that the EcoFit® Hip System is safe and effective for the proposed indications.
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| Test | Test Method | Results |
|---|---|---|
| Metallic Bone Screw Test(Torsional Properties, Driving Torque, Pull-Out Strength) | ASTM F 543 | Acceptable |
| Liner Disassembly Acetabular Shell - Liner(Push-Out, Lever-Out, Torsionals Properties) | ASTM F 1820 | Acceptable |
| Taper disassembly(Axial Disassembly Force Head - Femoral Stem) | ASTM F 2009 | Acceptable |
| Impingement EcoFit® Cup – Stem | ASTM F 2582 | Acceptable |
| Fatigue Strength EcoFit® Hip Stem – Distal | ISO 7206-4 | Pass |
| Fatigue Strength EcoFit® Hip Stem - Proximal (Neck Region) | ISO 7206-6 | Pass |
| Fretting corrosion evaluation | / | Acceptable |
| ROM EcoFit® Hip Stem – EcoFit® Cup | ISO 21535 Annex A | Acceptable |
| Biocompatibility | ISO 10993 | Pass |
CLINICAL TESTING:
Animal and clinical testing was not necessary to determine substantial equivalence between the EcoFit® Hip System and the predicate devices.
CONCLUSIONS:
Based on the intended use, materials, design and testing provided, the 510(k) demonstrates substantial equivalence to the predicate devices cited in this summary.
§ 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.