(129 days)
No
The document describes a mechanical hip implant and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a hip stem and bipolar head system intended to treat various conditions like degenerative joint disease, rheumatoid arthritis, fractures, and for revision procedures, which are all therapeutic interventions.
No
The device is a hip stem and head, which are prosthetic implants used for hip replacement surgery. They are used to treat conditions like degenerative joint disease and fractures, not to diagnose them.
No
The device description clearly describes a physical implantable device (hip stem and head) made of materials like Cobalt Chromium or Ceramic, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the OMNI ARC Monoblock Hip Stem is a femoral component of a total hip replacement. It is a physical implant intended for surgical insertion into the body.
- Intended Use: The intended use describes the conditions for which the hip stem is used as a surgical implant to replace or repair a damaged hip joint.
- No Mention of Samples or Testing: The text does not mention any use of samples from the body or any form of diagnostic testing.
Therefore, the OMNI ARC Monoblock Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OMNI ARC Monoblock Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex InterfaceTM Acetabular System. The Apex InterfaceTM 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 Monoblock Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur;
- Osteonecrosis of the femoral head;
- Revision procedures where other treatments or devices for these indications have failed.
Product codes
LZO, MEH, LPH, KWY
Device Description
The OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock 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 Monoblock Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- Femoral neck and trochanteric fractures of the proximal femur; Osteonecrosis of the femoral head; Revision procedures where other treatments or devices for these indications have failed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The results of testing of the proposed ARC Monoblock Hip Stems met the requirements for fatigue strength per ISO 7206-6 and ISO 7206-4 and the range-of-motion requirement per ISO 21535.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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| 510(K) SUMMARY | |
|---|---|
| Date Summary Prepared | November 1, 2013 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science |
| 50 O'Connell Way | |
| Suite 10 | |
| East Taunton, MA 02718 | |
| 510(k) Contact | Christina Flores |
| Manager, Regulatory Affairs | |
| Omnilife Science | |
| 50 O'Connell Way | |
| East Taunton, MA 02718 | |
| Telephone: 774-226-1835 | |
| Fax: 508-822-6030 | |
| Email: cflores@omnils.com | |
| Trade Name | OMNI ARC Monoblock Hip Stem |
| Common Name | prosthesis, hip, semi-constrained, |
| metal/polymer, porous uncemented | |
| prosthesis, hip, semi-constrained, uncemented, | |
| metal/polymer, non-porous, calcium-phosphate | |
| Classification Name | 21 CFR 888.3353 Hip joint |
| metal/ceramic/polymer semi-constrained | |
| cemented or nonporous uncemented | |
| prosthesis. LZO, MEH, LPH, KWY | |
| Predicate Device | K113242 - Apex Hip System ARCTM Hip Stem |
| (cleared size 0) | |
| K110947 - Apex K1TM Hip Stem | |
| Reference predicates: | |
| K111193 Apex Hip System ARCTM Hip Stem | |
| (cleared size 1-5) | |
| K060072 Apex K1 Hip Stem(cleared size 2-12) | |
| Purpose of Submission | This Traditional 510(k) premarket notification is |
| being submitted to obtain clearance for the | |
| OMNI ARC Monoblock Hip Stem to expand | |
| OMNI's product offering for total hip | |
| arthroplasty. | |
| 510(K) SUMMARY | |
| Device Description and intended use | The OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock 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™ Monoblock Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
Femoral neck and trochanteric fractures of the proximal femur; Osteonecrosis of the femoral head; Revision procedures where other treatments or devices for these indications have failed. |
| 510(K) SUMMARY | |
| Substantial Equivalence Summary | The OMNI ARC Monoblock Hip Stem is
substantially equivalent to the predicate APEX
ARC Hip Stem (K113242) and the Apex K1 Hip
Stem (K110947) in which the fundamental
scientific technology and intended uses are the
same. Any differences between the OMNI ARC
Monoblock Hip Stem and the predicates are
considered minor and do not raise questions
concerning safety and effectiveness.
The proposed devices are composed of
titanium alloy, unalloyed titanium plasma spray,
with hydroxyapatite coating, the identical
material used in the manufacture of the
predicate devices.
The results of testing of the proposed ARC
Monoblock Hip Stems met the requirements for
fatigue strength per ISO 7206-6 and ISO 7206-
4 and the range-of-motion requirement per ISO
21535. These test methods are the same used
for the predicate devices (K110947 and
K113242). Based on the indications for use,
technological characteristics, and the
comparison to the predicate devices, OMNIlife
Science has determined that the OMNI ARC
Monoblock Hip Stem is substantially equivalent
to currently marketed predicate devices. |
K133381 Al Response March 7, 2014
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K133381 Page 3/3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is a simple, straightforward presentation of the organization's name.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2014
OMNIlife Science Ms. Christina Flores Manager, Regulatory Affairs 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718
Re: K133381
Trade/Device Name: OMNI ARC Monoblock 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, MEH, LPH, KWY Dated: February 6, 2014 Received: February 10, 2014
Dear Ms. Flores:
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
4
Page 2 - Ms. Christina Flores
(21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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 vours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): Not Known K1 3 3 3 8 1
Device Name: OMNI ARC Monoblock Hip Stem
The OMNI ARC Monoblock 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 (Coball 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; .
- י Revision procedures where other treatments or devices have failed;
- . Femoral neck and trochanteric fractures of the proximal femur.
The OMNI ARC Monoblock Hip Stem is also intended for use in hemiathroplasty when used with the Apex Bipolar Head.
The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
- · Femoral neck and trochanteric fractures of the proximal femur;
- · Osteonecrosis of the femoral head;
- · Revision procedures where other treatments or devices for these indications have failed.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RC Monoblock Hip Stem
Page 15 of 172