(168 days)
K031110 Apex Acetabular Shell
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implant for hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. While it aims to restore function and alleviate pain, it acts as a replacement part rather than a direct therapeutic agent.
No
The device is an acetabular system designed for surgical implantation in hip arthroplasty, not for diagnosing conditions. It addresses existing conditions by replacing parts of the hip joint.
No
The device description explicitly states that the system consists of physical components made of titanium alloy and polyethylene, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the OMNI Interface Acetabular System is designed for use in hip arthroplasty. This is a surgical procedure involving the replacement of a joint.
- Device Description: The device is described as consisting of acetabular cups/shells, inserts, and femoral heads, which are components of a hip implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. The OMNI Interface Acetabular System is an implantable medical device used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The OMNI Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include -
- . 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 Interface Acetabular System is intended for cementless and single use implantation only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, MEH
Device Description
The OMNI Interface Acetabular System consists of acetabular cups/shells that are made of titanium alloy, standard and crosslinked ultra high molecular weight polyethylene shell inserts and femoral heads that are used with compatible femoral hip stems for primary and revision total hip replacement. The shells are available in “no hole” and “3-hole” configuration and a size range from 46-76 mm and X size (48x-58xmm).
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)
The results of testing for the proposed use of OMNI Interface Acetabular System with the Paragon Stem met the performance requirements for range of motion per ISO 21535.
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.
K112779 Apex Interface Acetabular System, K060635 Consensus Acetabular Shell System, K123782 Paragon Hip System
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.
K031110 Apex Acetabular Shell
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
OMNIlife Science, Inc. Ms. Vani Sindwani Regulatory Affairs Specialist 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718
Re: K142201
Trade/Device Name: OMNI Interface™ Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: November 25, 2014 Received: November 28, 2014
Dear Ms. Sindwani:
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
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Page 2 - Ms. Vani Sindwani
(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 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Lori A. Wiggins -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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510(k) Number (if known): K142201
Device Name: OMNI (previously Apex) Interface™ Acetabular System
Indications for Use:
The OMNI Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include -
- . 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 Interface Acetabular System is intended for cementless and single use implantation only.
X AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (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)
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510(k) Summary
| TABLE 1: 510(k) SUMMARY | |
|---|---|
| Date Summary Prepared | 08/08/2014 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science, Inc. |
| 50 O'Connell Way | |
| Suite 10 | |
| East Taunton, MA 02718 | |
| 510(k) Contact | Vani Sindwani |
| Regulatory Affairs Specialist | |
| OMNIlife Science | |
| 50 O' Connell Way | |
| Suite 10 | |
| East Taunton, MA 02718 | |
| Telephone: 774-226-1871 | |
| Fax: 508-822-6030 | |
| Email: vsindwani@omnils.com | |
| Trade Name | OMNI Interface™ Acetabular System |
| Common Name | Prosthesis, hip, semi-constrained, metal/polymer, |
| porous uncemented | |
| Classification | 21 CFR 888.3358 Hip joint metal/polymer/metal semi- |
| constrained porous-coated uncemented prosthesis. LPH | |
| Predicate Device | K112779 Apex Interface Acetabular System |
| K060635 Consensus Acetabular Shell System | |
| K123782 Paragon Hip System |
Reference Predicates:
K031110 Apex Acetabular Shell |
| Purpose of Submission | This traditional 510(k) premarket notification is being
submitted to expand the indications for OMNI Interface
Acetabular System. Through this premarket notification
OMNI intends to obtain clearance for the use of OMNI
Interface Acetabular System with Global's Paragon
stem cleared via K123782. |
| Device Description and Intended Use | The OMNI Interface Acetabular System consists of
acetabular cups/shells that are made of titanium alloy,
standard and crosslinked ultra high molecular weight
polyethylene shell inserts and femoral heads that are
used with compatible femoral hip stems for primary and |
| | revision total hip replacement. The shells are available
in “no hole” and “3-hole” configuration and a size range
from 46-76 mm and X size (48x-58xmm). |
| | The OMNI Interface™ Acetabular System is designed
to be used in hip arthroplasty. The specific indications
for use include -
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 Interface Acetabular System is intended for
cementless and single use implantation only. |
| Substantial Equivalence Summary | The OMNI Interface Acetabular System is substantially
equivalent to the predicates as the basic design,
interface, fundamental technology, materials and
intended use are the same. |
| | Paragon stem (K123782) is cleared to be used in
conjunction with a compatible femoral head and
acetabular component and is used with Consensus CS2
Acetabular Shell System (K060635). OMNIlife science
has determined OMNI Interface Acetabular System to
be substantially equivalent to CS2 Acetabular Shell
System thereby supporting its use with the Paragon
stem. |
| | The use of OMNI Interface Acetabular System with the
Paragon stem is determined to be as safe and effective
as the predicate and does not raise any new safety or
effectiveness concerns. The results of testing for the
proposed use of OMNI Interface Acetabular System
with the Paragon Stem met the performance
requirements for range of motion per ISO 21535 |
| The comparison between OMNI hip stems and the
Paragon stem, and OMNI and Global femoral heads
have been included in this submission that further
supports the compatibility of OMNI Interface
Acetabular System and Paragon Stem. | |
| Based on the identical material, the design and
characterization data, compatibility and mechanical
testing, and technological characteristics, OMNIlife
science believes the proposed OMNI Interface
Acetabular System to be substantially equivalent to
legally marketed predicates and can be used with
Paragon stem for primary and revision hip arthroplasty. | |
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