(128 days)
Not Found
No
The document describes a mechanical hip stem and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to treat various medical conditions related to the hip, such as degenerative joint disease, rheumatoid arthritis, and fractures, which aligns with the definition of a therapeutic device.
No
Explanation: The OMNI ARC Hip Stem is an orthopedic implant for total hip replacement, used to treat conditions like degenerative joint disease and fractures. It is a therapy device, not a diagnostic one.
No
The device description clearly indicates the device is a physical hip stem made of Ti-6Al-4V E.L.I, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as a femoral component of a primary or revision total hip replacement. This is a surgical implant used in vivo (within the body) to replace a damaged joint.
- Device Description: The device is described as a hip stem made of a specific material (Ti-6Al-4V E.L.I). This is a physical implant.
- Anatomical Site: The anatomical site is the femoral component of a primary or revision total hip replacement, which is part of the skeletal system within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to replace a joint.
N/A
Intended Use / Indications for Use
The OMNI ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI ARCTM Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.
Product codes
LZO
Device Description
The proposed devices are intended to be used for primary and revision total hip replacement. The OMNI ARC Anteverted Neck Hip Stem offers anteverted neck options (left and right orientations) to the monoblock stem system to meet the variety of patient anatomies expected in Total Hip Arthroplasty. This design is similar to the ARC Monoblock stem designs currently marketed. The material of the proposed OMNI ARC Anteverted Neck Hip Stems are Ti-6Al-4V E.L.I (ASTM F136)
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
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)
Testing was not conducted but the devices were evaluated and no-testing justifications were written.
The following justifications were written to explain the safety and effectiveness of the OMNI ARC Hip Stem with the proposed modifications. The modifications do not raise any new safety or effectiveness concerns.
- HTR-082 ARC Monoblock Fatigue FEA Anteverted Neck
- HTR-099 ARC Monoblock Anteverted Neck ROM
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue. The word "Administration" is on the second line.
December 21, 2017
OMNIlife science Christina Rovaldi Regulatory Affairs Specialist 480 Paramount Drive Raynham, Massachusetts 02767
Re: K172467
Trade/Device Name: OMNI ARC Anteverted Neck Hip Stem 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: October 4, 2017 Received: October 5, 2017
Dear Christina Rovaldi:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
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)
K172467 Device Name OMNI ARC Anteverted Neck Hip Stem
Indications for Use (Describe)
The OMNI ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate:
- · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Congenital dislocation;
- · Revision procedures where other treatments or devices have failed;
- · Femoral neck and trochanteric fractures of the proximal femur.
The OMNI ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.
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)
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510(k) Summary
| TABLE 1: 510(k) SUMMARY | |
|---|---|
| Date Summary Prepared | 10/4/2017 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science, Inc. |
| 480 Paramount Drive | |
| Raynham MA 02767 | |
| 510(k) Contact | Christina Rovaldi |
| Sr. Regulatory Affairs Specialist | |
| OMNIlife Science | |
| 480 Paramount Drive | |
| Raynham MA 02767 | |
| Telephone: 774-226-1857 | |
| Fax: 508-822-6030 | |
| Email: crovaldi@omnils.com | |
| Trade Name | OMNI ARC Anteverted Neck Hip Stem |
| Common Name | Prosthesis, hip, semi-constrained, |
| metal/ceramic/polymer, cemented or non-porous, | |
| uncemented. | |
| Classification | 21 CFR 888.3353 prosthesis, hip, semi-constrained, |
| metal/ceramic/polymer, cemented or non-porous, | |
| uncemented | |
| LZO | |
| Predicate Device | K133381 OMNI ARC Monoblock Hip Stem |
| Purpose of Submission | This Traditional 510(k) premarket notification is being |
| submitted to propose modifications to the OMNI ARC | |
| Monoblock Hip Stem (K133381) by adding additional | |
| monoblock stem types to expand the product offering. | |
| Intended Use | The OMNI ARC Hip Stem is intended for use as the |
| femoral component of a primary or revision total hip | |
| replacement when used with the Apex Interface™ | |
| Acetabular System. The Apex Interface™ Acetabular | |
| System articulates with the Apex Modular Femoral | |
| Head (Cobalt Chromium or Ceramic). The femoral hip | |
| stem is intended for uncemented fixation and single use | |
| implantation. These prostheses may be used for hip | |
| arthroplasty to treat the following conditions, as | |
| appropriate: | |
| Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI ARCTM Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use. | |
| Device Description | The proposed devices are intended to be used for primary and revision total hip replacement. |
The OMNI ARC Anteverted Neck Hip Stem offers anteverted neck options (left and right orientations) to the monoblock stem system to meet the variety of patient anatomies expected in Total Hip Arthroplasty. This design is similar to the ARC Monoblock stem designs currently marketed.
The material of the proposed OMNI ARC Anteverted Neck Hip Stems are Ti-6Al-4V E.L.I (ASTM F136) |
| Substantial Equivalence Summary | The proposed devices with modifications are substantially equivalent to the existing OMNI ARC Monoblock Hip Stem cleared in K133381 as the basic design, interface, fundamental technology, materials and intended use are the same.
The use of the new OMNI ARC Anteverted Neck Hip Stem components with the existing ARC Monoblock Hip Stem does not introduce any new risks of safety or efficacy.
Testing was not conducted but the devices were evaluated and no-testing justifications were written |
| | The following justifications were written to explain the
safety and effectiveness of the OMNI ARC Hip Stem
with the proposed modifications. The modifications do
not raise any new safety or effectiveness concerns. |
| | - HTR-082 ARC Monoblock Fatigue FEA Anteverted
Neck |
| | - HTR-099 ARC Monoblock Anteverted Neck ROM |
| | The justifications are described in section 12, Device
Description. |
| | Based on the design, fundamental technology, identical
material, intended use and technological
characteristics, OMNIlife science believes the proposed
OMNI ARC Anteverted Neck Hip Stem devices to be
substantially equivalent to legally marketed predicates. |
| Conclusion Statement | OMNIlife science has demonstrated the proposed
OMNI ARC Anteverted Neck Hip Stem is substantially
equivalent to the predicate device based upon
indications for use, design, test results and the same
fundamental scientific technology. |
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