(66 days)
Apex Knee System K060192
No
The summary describes a mechanical implant (tibial baseplate augment) and its intended use and testing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a knee replacement system intended to treat conditions such as degenerative joint disease and rheumatoid arthritis, which are therapeutic interventions.
No
Explanation: The device is a knee implant component (Tibial Baseplate Augment) used in total knee replacement, not for diagnosing conditions. Its intended use is for treatment, specifically as a spacer in knee replacement surgery.
No
The device description clearly indicates the device is a physical implant (Tibial Baseplate Augment) made of material intended for cemented fixation in a knee replacement procedure. It is not software.
No, 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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Apex Knee System Tibial Baseplate Augment is a physical implant designed to be surgically placed inside the human body as part of a knee replacement.
- Intended Use: The intended use clearly states it's for "primary or revision total knee replacement" and is "cemented fixation and single use implantation." This describes a surgical implant, not a diagnostic test.
The information provided describes a medical device used for treatment (knee replacement), not for diagnosing a condition by testing samples.
N/A
Intended Use / Indications for Use
The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed.
Product codes
JWH
Device Description
The Augments are used as optional spacers and are cemented below the Tibial Tray using PMMA bone cement.
The Tibial Baseplate Augment is available in the following Sizes:
• Size 1 x 8mm
• Size 2 x 8mm
• Size 3 x 8mm
• Size 4 x 8mm
• Size 5 x 8mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Performance testing, design comparisons, and functional analysis conducted on the Augments demonstrate that they are equivalent to the predicate devices.
The Apex Tibial Baseplate Augments were bench tested to assure usability and function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tibial Spacer for the Natural Knee K031183
Reference Device(s)
Apex Knee System K060192
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510 (k) Summary
For the OMNI life science Apex Knee System Tibial Baseplate Augment
| Submitter | OMNI life science, Inc.
50 O'Connell Way #10
E. Taunton, MA 02718 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MAR - 5 2010 |
| Contact Person | Robert Zoletti
OMNI life science, Inc.
50 O'Connell Way #10
E. Taunton, MA 02718
Tel: 774-226-1845
Fax: 508-822-6030
Email: rzoletti@omnils.com |
| Preparation Date | February 26, 2010 |
| Common Name | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,
polymer/metal/polymer |
| Trade Name | Apex Knee System Tibial Baseplate Augment |
| Classification Name | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented,
polymer/metal/polymer |
| Classification Panel | Orthopedic (OR) |
| Regulatory Class | Class II per 21 CFR 888.3560 |
| Product Code | JWH |
| Legally Marketed | Apex Knee System K060192 |
| Predicate Device(s) | Tibial Spacer for the Natural Knee K031183 |
| Device Description | The Augments are used as optional spacers and are cemented below the
Tibial Tray using PMMA bone cement.
The Tibial Baseplate Augment is available in the following Sizes:
• Size 1 x 8mm
• Size 2 x 8mm
• Size 3 x 8mm
• Size 4 x 8mm
• Size 5 x 8mm |
| Indications for Use | The Apex Knee System Tibial Baseplate Augment is intended for use with
the Apex Knee System as a primary or revision total knee replacement. This
knee replacement system is intended for cemented fixation and single use
implantation. This prosthesis may be used for the following conditions, as
appropriate:
• Non-inflammatory degenerative joint disease, including |
| • | Rheumatoid arthritis; |
osteoarthritis and avascular necrosis;
1
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:
: · · ·
.
:
.
. . .
- . Correction of functional deformity;
- Revision procedures where other treatments or devices have failed. .
and the comments of the comments of
| Technological
Characteristics | The Augments are manufactured from Ti-6Al-4V and designed for use with
the Apex Knee System cleared in K060192. |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence
Comparison | Performance testing, design comparisons, and functional analysis
conducted on the Augments demonstrate that they are equivalent to the
predicate devices. |
| Clinical and Non-Clinical
Data | The Apex Tibial Baseplate Augments were bench tested to assure usability
and function. |
| Packaging and
Sterilization | Packaged Sterile
EO Sterilized, SAL 10-6
Shelf life is 5 years from date of manufacture |
.
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 5 2010
OMNI Life Science, Inc. % Mr. Robert Zoletti 50 O'Connell Way #10 East Taunton, Massachusetts 02718
Re: K094017
Trade/Device Name: Apex Knee System Tibial Baseplate Augment Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemoraltibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH
Dated: February 12, 2010 Received: February 16, 2010
Dear Mr. Zoletti:
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
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Page 2 - Mr. Robert Zoletti
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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ababare Bryent
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K094017
Device Name: Apex Knee™ System Cemented Tibial Augment
Indications for Use
The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:
- . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- � Rheumatoid arthritis;
- Correction of functional deformity: .
- Revision procedures where other treatments or devices have failed. .
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter 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)
Orita for mxn
(Division Sign. Division of Surgical, Orthopedic, and Restorative Devices
510(k) Numbe
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OMNI life science
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