(112 days)
K210581 DePuy Orthopaedic Inc. ACTIS® Duofix Hip Prothesis
No
The document describes a mechanical hip replacement system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a total hip replacement system, which aims to alleviate pain and disability in patients with severe joint conditions, thus providing a therapeutic benefit by restoring function.
No
This device is a total hip replacement system, which is a prosthetic implant used in surgery, not a device for diagnosing medical conditions. It aids in treating conditions like osteoarthritis or fractures, rather than identifying them.
No
The device description clearly states it is comprised of physical components (femoral stem, acetabular components, instruments) and is a total hip replacement system. While it mentions digital x-ray templates, the core device is hardware.
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 procedure for replacing a hip joint due to various conditions. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as a total hip replacement system comprised of implants (femoral stem, femoral head, acetabular cup, liner, screws) and instruments. These are physical components used in surgery.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. The provided text does not mention any use of patient specimens or diagnostic testing.
Therefore, the Actera™ hip system is a surgical implant and associated instruments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Total hip replacement using the Actera™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
· Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or surgical technique.
Product codes (comma separated list FDA assigned to the subject device)
MEH, OOG
Device Description
The Actera™ hip system is an uncemented, total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. X-ray templates, acetate or digital, are provided for determining implant sizes and component placement. Non-sterile reusable instruments are provided. The subject Actera™ hip system is comprised of the subject Actera™ femoral stem and the previously cleared compatible femoral head, Cordera acetabular cup, Cordera cup liner and Cordera screws (predicate K202484).
The subject, Actera™ femoral stem, is a re-designed stem. The stem is a proximally filling, triple-tapered design that is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581).
The femoral stem has an integrated neck with neck angle of 132° and neck length that progressively increases with stem size. Each size has two neck options: a standard neck, and a high offset neck that is shifted medially to provide additional femoral offset with the same leg length. The trunnion is a Conformis standard 12/14 taper, possessing a 12.7 mm diameter along with 5° 42′ 30″ angle with an asmachined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to that of the predicate Conformis Cordera femoral stem. The trunnion is designed to mate with existing standard 12/14 femoral heads. The stem body has a smooth tapered geometry in three planes. The proximal neck surface of the stem is highly polished; its geometry is intended to maximize range of motion. The femoral stems are designed to maximize contact between the stem and cancellous bone of the intramedullary canal and utilize press-fit fixation. The stem body is fully coated with hydroxyatite (HA) coating in conformance to ASTM F1185 on top of a proximal coating of commercially pure titanium (CPTi) conforming to ASTM F1580.
The femoral heads are unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (BIOLOX® delta). The femoral heads are designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem.
The acetabular component is unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). It consists of a standard size shell in 1mm increments with standard screw hole placement, a mating vitamin E polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation.
The purpose of this submission is to seek clearance of the subject Actera™ femoral stem which is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581). The subject Actera femoral stem is compatible with the previously cleared femoral head, Cordera acetabular cup and liner, Cordera screws and reusable instruments (class I) as described in the predicate K210581. . This submission also seeks clearance for new class II reusable instruments. New class I 510Kexempt reusable instruments and x-ray templates are also described.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature individuals
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)
Performance testing includes proximal stem fatigue testing (ISO 7206-6), distal stem fatigue testing (ISO 7206-4), range of motion analysis per ISO 21535, impingement analysis, and coating characterization testing (ASTM F1854 stereological porous coating evaluation, ASTM F1147 static tensile testing, ASTM F1044 static shear testing, ASTM F1160 shear and bending fatigue testing, ASTM F1978 Taber abrasion testing, ASTM F1926 dissolution rate testing, ASTM F2024 phase composition testing per X-ray diffraction, and Ca/P ratio characterization testing using XRD analysis or wet chemistry method). Limulus Amebocyte Lysate (LAL) testing using the gel-clot method is employed to monitor the endotoxin levels of the subject and predicate implanted device and ensures they are within the recommended levels of 0.5 EU/mL or 20 EU/device. Verification and validation studies were also conducted. The results of the testing support that the subject device is safe, effective and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised.
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.
K210581 DePuy Orthopaedic Inc. ACTIS® Duofix Hip Prothesis
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.
K202484 Conformis Cordera Hip System
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
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August 4, 2022
Conformis Inc. Mary Kruitwagen Sr. Regulatory Affairs Specialist 600 Technology Park Drive, 4th Floor Billerica, Massachusetts 01821
Re: K221104
Trade/Device Name: Actera™ 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: MEH, OOG Dated: May 24, 2022 Received: May 25, 2022
Dear Mary Kruitwagen:
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 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,
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
510(k) Number (if known) K221104
Device Name Actera™ hip system
Indications for Use (Describe)
Total hip replacement using the Actera™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
· Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or surgical technique.
| 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
| Submitter's Name and Address: | Conformis, Inc.
600 Technology Park Drive,
Fourth Floor
Billerica, MA 01821
USA |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number(s): | 3009844603 and 3004153240 |
| Date Summary was Prepared: | July 19, 2022 |
| Contact Person: | Mary Kruitwagen
Sr. Regulatory Affairs Specialist |
| Contact Information: | Mary.Kruitwagen@conformis.com
781-345-9038 |
| Trade/Device Name(s) | Actera™ hip system |
| Common Name: | Total Hip Replacement System |
| Device Class: | Class 2 |
| Regulation Number(s) and
Classification Names | 21 CFR 888.3353, Hip Joint Metal/Ceramic/Polymer Semi-Constrained
Cemented Or Nonporous Uncemented Prosthesis
21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis |
| Product Codes: | Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-
porous, calcium phosphate (MEH)
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, +
Additive, Porous, Uncemented (OQG) |
| Primary Predicate Device: | K210581 DePuy Orthopaedic Inc. ACTIS® Duofix Hip Prothesis |
| Reference Device: | K202484 Conformis Cordera Hip System |
Device Description:
The Actera™ hip system is an uncemented, total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. X-ray templates, acetate or digital, are provided for determining implant sizes and component placement. Non-sterile reusable instruments are provided. The subject Actera™ hip system is comprised of the subject Actera™ femoral
4
stem and the previously cleared compatible femoral head, Cordera acetabular cup, Cordera cup liner and Cordera screws (predicate K202484).
The subject, Actera™ femoral stem, is a re-designed stem. The stem is a proximally filling, triple-tapered design that is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581).
The femoral stem has an integrated neck with neck angle of 132° and neck length that progressively increases with stem size. Each size has two neck options: a standard neck, and a high offset neck that is shifted medially to provide additional femoral offset with the same leg length. The trunnion is a Conformis standard 12/14 taper, possessing a 12.7 mm diameter along with 5° 42′ 30″ angle with an asmachined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to that of the predicate Conformis Cordera femoral stem. The trunnion is designed to mate with existing standard 12/14 femoral heads. The stem body has a smooth tapered geometry in three planes. The proximal neck surface of the stem is highly polished; its geometry is intended to maximize range of motion. The femoral stems are designed to maximize contact between the stem and cancellous bone of the intramedullary canal and utilize press-fit fixation. The stem body is fully coated with hydroxyatite (HA) coating in conformance to ASTM F1185 on top of a proximal coating of commercially pure titanium (CPTi) conforming to ASTM F1580.
The femoral heads are unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (BIOLOX® delta). The femoral heads are designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem.
The acetabular component is unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). It consists of a standard size shell in 1mm increments with standard screw hole placement, a mating vitamin E polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation.
The purpose of this submission is to seek clearance of the subject Actera™ femoral stem which is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581). The subject Actera femoral stem is compatible with the previously cleared femoral head, Cordera acetabular cup and liner, Cordera screws and reusable instruments (class I) as described in the predicate K210581. . This submission also seeks clearance for new class II reusable instruments. New class I 510Kexempt reusable instruments and x-ray templates are also described.
Indications for Use:
Total hip replacement using the Actera™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
• A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
5
- Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.
Indications and Technological Characteristics Comparison:
The indications for use in total hip replacement are similar to the primary predicate. The subject indications for use differ from the primary predicate because the subject system is not indicated for use in hemi-hip replacement. However, the subject device indications for use are almost identical to the reference device total hip replacement system and only differ through modification to include the lateral approach. The subject device incorporates total hip arthroplasty components with materials and designs that are the similar to the DePuy Orthopaedics ACTIS® DuoFix Hip Prothesis, K210581 predicate. The operating principle, fundamental technology, materials, manufacturing methods and sterilization options are the same as the predicate.
Non-Clinical Performance Evaluation:
Performance testing includes proximal stem fatigue testing (ISO 7206-6), distal stem fatigue testing (ISO 7206-4), range of motion analysis per ISO 21535, impingement analysis, and coating characterization testing (ASTM F1854 stereological porous coating evaluation, ASTM F1147 static tensile testing, ASTM F1044 static shear testing, ASTM F1160 shear and bending fatigue testing, ASTM F1978 Taber abrasion testing, ASTM F1926 dissolution rate testing, ASTM F2024 phase composition testing per X-ray diffraction, and Ca/P ratio characterization testing using XRD analysis or wet chemistry method). Limulus Amebocyte Lysate (LAL) testing using the gel-clot method is employed to monitor the endotoxin levels of the subject and predicate implanted device and ensures they are within the recommended levels of 0.5 EU/mL or 20 EU/device. Verification and validation studies were also conducted. The results of the testing support that the subject device is safe, effective and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised.
Conclusion:
Based on a comparison of the intended use and technological characteristics of the subject device to predicate, and the results of the confirmatory testing, it is concluded that the proposed Actera™ hip system is considered substantially equivalent.