(141 days)
Not Found
No
The description focuses on the mechanical components and surgical options of a total knee replacement system, with no mention of AI or ML capabilities.
Yes
The device is intended to treat conditions such as non-inflammatory degenerative joint disease, rheumatoid arthritis, and correction of functional deformity, as well as serving as a revision option for failed treatments. These uses directly address and alleviate medical conditions.
No
Explanation: The Apex Knee System is described as a total knee replacement system, intended for surgical implantation to replace a diseased or damaged knee joint. Its purpose is to treat conditions like osteoarthritis and rheumatoid arthritis by replacing the joint, not by diagnosing them.
No
The device description clearly outlines multiple hardware components made of cobalt chrome, UHMWPE, and titanium alloy, which are physical implants for knee replacement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "primary or revision total knee replacement." This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the components of a knee implant (femoral components, patella components, tibial inserts, tibial trays, bolt). These are physical parts designed to be surgically implanted into a patient's knee joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
The Apex Knee System is a surgical implant used for total knee replacement.
N/A
Intended Use / Indications for Use
The Apex Knee System is intended for use 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 (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Apex Knee System is a primary or revision total knee replacement. This knee replacement is intended for use with bone cement and single use implantation. This knee system consists of a range of sizes of cobalt chrome femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a size-for-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.
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)
Not Found
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.
K943462, K961685, K973412, K021578
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.
Not Found
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
§ 888.3560 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.
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EXHIBIT A 510(K) Summary
Apex Knee System
January 23, 2006
- Submitter: OMNI life science™, Inc. 1390-A Decision Street Vista, CA 92081
- Contact: Ms. Christine Otis Requlatory and Quality Systems (760) 734-1550 x134 (voice) (760) 734-1577 (fax)
2. Device Name
| Proprietary Name: | Apex Knee System |
|---|---|
| Common Name: | Knee prosthesis, cemented |
| Classification Name: | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer |
| Regulatory Class: | Class II per 21 CFR §888.3560 |
3. Intended Use
The Apex Knee System is intended for use 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. .
4. Device Description
The Apex Knee System is a primary or revision total knee replacement. This knee replacement is intended for use with bone cement and single use implantation. This knee system consists of a range of sizes of cobalt chrome femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a size-for-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.
1
5. Predicate Device Comparison
Substantial equivalence is claimed to the P.F.C. Sigma Fixed Bearing Cruciate-Substantial equivalence is clauned to the 1. . . . . Relaining Rilee System uistibuted by Dr. ay Orthopsterior distributed by Zimmer, Inc. The Cruciale Retaining and Postoner Stablishes and differences between the Apex Knee System and these predicate devices:
| | Apex Knee | P.F.C. ® Sigma*
(K943462, K961685) | Natural-Knee® II*
(K973412, K021578) |
|--------------------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision, 3
compartment, cemented | Yes | Yes | Yes |
| DESIGN | | | |
| Porous coated | No | No | No |
| Asymmetric femur,
anatomic patella groove | Yes | Yes | Yes |
| Anatomic (asymmetric)
tibial tray | Yes | No | Yes |
| Metal-backed UHMWPE
tibial component | Yes | Yes | Yes |
| Tibial insert designs | CR and Ultra | CR ("Curved") | CR ("Congruent")
and Ultra
("Ultracongruent") |
| Tibial tray distal features | Central post and
2 keels | Central post and
2 short keels | Central post, 4
keels, and 4 pegs |
| Patella design | Round, single
radius dome, 3
pegs | Round, single
radius dome, 3
pegs | Round, partial
dome, 3 pegs |
| MATERIALS | | | |
| Cobalt chrome femur | Yes | Yes | Yes |
| CoCr tibial tray | Yes | No - ti alloy | Yes |
| All-poly patella | Yes | Yes | Yes |
| UHMWPE | Sheet molded
GUR 1020 | Sheet molded
GUR 1020 | Sheet molded
GUR 1020 |
| Highly cross-linked
UHMWPE (sterilization) | No (EtO) | No (y irradiation
in vacuum) | No (y irradiation in
nitrogen) |
The most significant difference between these devices is that the Apex Knee employs The most sighthoum unforonoo bother tibial tray using two parallel "dovetail" rails on INVI E «blar hoons the predicate devices employ UHMWPE inserts that are snapfit into the tibial tray.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 15 2006
OMNI life science, Inc. % Edward J. Cheal, Ph.D. Vice President of Research 175 Paramount Drive, Suite 302 Raynham, Massachusetts 02767
Re: K060192
Trade/Device Name: Apex Knee™ System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: May 15, 2006 Received: May 16, 2006
Dear Dr. Cheal:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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): good manufacturing practice requirements as set
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Page 2 - Edward J. Cheal, Ph.D.
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon ohtain 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html.
Sincerely yours,
Barbara Mnechuk
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Apex Knee™ System
Indications For Use:
The Apex Knee System is intended for use 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 X (Per 21 CFR 801 Subpart D) AND/OR
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)
Page 1 of __
(Division Sign-Division of General, estorative. and Neurological De
510(k) Number.__
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