(72 days)
No
The document describes a physical medical device (hip stem) and its intended use and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a hip stem used in total or hemi hip arthroplasty to treat various joint diseases and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
The device is a hip stem intended for use in total or partial hip arthroplasty, which is a treatment (replacement) and not a diagnostic procedure.
No
The device description clearly states the Actinia® hip stems are physical femoral stems made from titanium alloy with a hydroxyapatite coating, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, the Actinia® hip stems are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Actinia® Hip Stems Function: The description clearly states that the Actinia® hip stems are implants used in surgical procedures (total and partial hip arthroplasty) to replace damaged parts of the hip joint. They are a physical component inserted into the body.
- Intended Use: The intended use describes the clinical conditions for which the implant is used, not a diagnostic test performed on a sample.
- Device Description: The description details the material, design, and fixation method of the implant.
- Performance Studies: The performance studies focus on the mechanical properties and durability of the implant, not the accuracy or reliability of a diagnostic test.
Therefore, the Actinia® hip stems fall under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Actinia® 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 Actinia® hip stems cementless are intended for uncemented, press-fit fixation.
The Actinia® 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, KWY
Device Description
The purpose of this Traditional 510(k) is to introduce into interstate commerce in the United States the Actinia® hip stems. The Actinia® hip stems are femoral stems for total or hemi hip arthroplasty. The Actinia® hip stems include collared and collarless variants in standard and lateralized offset configurations. Additionally, the scope includes the coxa vara hip stem variant in a standard offset configuration.
The Actinia® hip stems are monoblock, tapered straight stems made from titanium alloy with a coating of hydroxyapatite (HA). They are fixed by press-fitting.
The Actinia® hip stems are to be used alongside other previously cleared components to make a complete prosthesis. Specifically, Actinia® hip stems are compatible with legally marketed heads used with the implantcast EcoFit® Hip System (K1635577, K180263 and K191569) and the implantcast ic-Bipolar Head System (K191569).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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" components of the Actinia® hip stems to assure substantial equivalence to its predicate and reference devices and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of or worstcase compared to the finished device. The following evaluations were conducted to characterize the devices:
- Fatigue Testing (ISO 7206-4 and ISO 7206-6)
- Impingement Testing (ASTM F2582-14)
- Taper Disassembly Testing (ASTM F2009)
- Range of Motion (ROM) Evaluation (ISO 21535)
- Coating Characterization (ASTM F1609, ASTM F1926, ASTM F2024, and ISO 13779)
- Corrosion and Fretting Performance Rationale
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.
implaFit® hip stems (K210678)
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.
DePuy Orthopaedics, Inc. Corail AMT Hip Prosthesis (K203167), EcoFit® Hip System (K163577, K180263, K191569 and K203420)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
October 19, 2023
implantcast, GmbH % Juliane Hoppner Regulatory Affairs Manager Implantcast GmbH Luneburger Schanze 26 Buxtehude, Germany
Re: K232371
Trade/Device Name: Actinia® hip stems 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, MEH, KWY Dated: August 8, 2023 Received: August 8, 2023
Dear Juliane Hoppner:
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 (OS) 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 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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the text "Limin Sun -S" in a large, bold font. The text is black and is set against a white background. The letters are evenly spaced and easy to read. There is a light blue watermark in the background.
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: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K232371
Device Name Actinia® hip stems
Indications for Use (Describe)
The Actinia® 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 Actinia® hip stems cementless are intended for uncemented, press-fit fixation.
The Actinia® 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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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: | Ms. Hannah Irwin
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5820
hirwin@mcra.com |
| Date Prepared: | October 17, 2023 |
| Device Trade Name: | Actinia® hip stems |
| Device Class and
Common Name: | Class II, Uncemented Hip Prothesis |
| Classification: | 21 CFR 888.3353: Hip Joint Metal/Ceramic/Polymer Semi-
Constrained Cemented or Nonporous Uncemented Prosthesis
21 CFR 888.3390: Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented prosthesis |
| Product Codes: | LZO, MEH, KWY |
| Indications for Use: | The Actinia® 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. |
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The Actinia® hip stems cementless are intended for uncemented, press-fit fixation.
The Actinia® 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 introduce Device Description: into interstate commerce in the United States the Actinia® hip stems. The Actinia® hip stems are femoral stems for total or hemi hip arthroplasty. The Actinia® hip stems include collared and collarless variants in standard and lateralized offset configurations. both Additionally, the scope includes the coxa vara hip stem variant in a standard offset configuration.
The Actinia® hip stems are monoblock, tapered straight stems made from titanium alloy with a coating of hydroxyapatite (HA). They are fixed by press-fitting.
The Actinia® hip stems are to be used alongside other previously cleared components to make a complete prosthesis. Specifically, Actinia® hip stems are compatible with legally marketed heads used with the implantcast EcoFit® Hip System (K163577, K180263 and K191569) and the implantcast ic-Bipolar Head System (K191569).
-
Predicate Devices: · implaFit® hip stems (K210678)
Reference Devices: -
DePuy Orthopaedics, Inc. Corail AMT Hip Prosthesis . (K203167)
-
EcoFit® Hip System (K163577, K180263, K191569 and . K203420)
Substantial The Actinia® hip stems are similar to components previously cleared with the implaFit® hip stems (K210678). Both feature Equivalence: cementless femoral hip stems that are monoblock, tapered (12/14) and made from titanium alloy. The indications for the
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subject and predicate devices are identical, with the exception of the implaFit® hip stems also include hip stems for cemented use, as well as cementless; equivalence is only claimed for the cementless indications.
There are some differences in stem material, geometry, and dimensions for the Actinia® hip stems as compared to the implaFit® hip stems predicate. These differences include stem coating, collarless design, cross-sectional geometry, stem length (shoulder to tip and lower shoulder to tip), neck length, and offset length.
The Actinia® hip stems are substantially equivalent to the hip stems of the legally marketed predicate and reference device systems, the implaFit® him stems, DePuy Orthopaedics, Inc. Corail AMT Hip Prothesis and EcoFit® Hip System, with respect to design and intended use.
- Performance Testing: All necessary testing has been performed for the "worst-case" components of the Actinia® hip stems to assure substantial equivalence to its predicate and reference devices and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of or worstcase compared to the finished device. The following evaluations were conducted to characterize the devices:
- Fatigue Testing (ISO 7206-4 and ISO 7206-6) ●
- . Impingement Testing (ASTM F2582-14)
- Taper Disassembly Testing (ASTM F2009)
- Range of Motion (ROM) Evaluation (ISO 21535)
- Coating Characterization (ASTM F1609, ASTM F1926, ● ASTM F2024, and ISO 13779)
- Corrosion and Fretting Performance Rationale .
The Actinia® hip stems subject to this submission possess the Conclusions: same intended use and similar technological characteristics as the predicate and reference device system components. All performance testing conducted for the Actinia® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the Actinia® hip stems components are substantially equivalent to the predicate devices for the intended use.