(55 days)
No
The 510(k) summary describes a standard knee replacement system with no mention of AI or ML technology in its intended use, device description, or performance studies.
No
The device is a knee replacement system intended to restore function and correct deformities related to knee joint diseases, thus providing a therapeutic effect. However, according to the provided information, it is not described as a "therapeutic device" in the traditional sense of a device delivering therapy (e.g., electrical stimulation, drug delivery). It is a surgical implant designed to replace a damaged joint, which is a structural and mechanical intervention rather than a therapeutic one.
No
The device is a knee replacement system intended for surgical implantation, not for diagnosing medical conditions. Its purpose is to replace a damaged knee joint.
No
The device description clearly details physical components made of cobalt chrome, UHMWPE, and titanium alloy, intended for surgical implantation as a total knee replacement system. This is a hardware medical device, not software-only.
Based on the provided information, the Apex Knee System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "primary or revision total knee replacement." This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details the components of a knee prosthesis (femoral components, patella components, tibial inserts, tibial trays, etc.). These are physical implants designed to replace a joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory tests.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or other conditions. The Apex Knee System is a therapeutic device used to surgically replace a damaged knee joint.
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, with the option of using a porous coated femoral component for uncemented or cemented fixation. 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, MBH
Device Description
The Apex Knee System Porous Coated Femoral Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome femoral components have a sintered porous coating (ASTM F1377). Fixation of the femoral component is achieved using either PMMA bone cement or by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System consists of a range of sizes of 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 sizefor-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 joint
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.
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.
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.
0
Apex Knee System
- Device Name
December 20, 2007
- Submitter: OMNI life science™, Inc. 175 Paramount Drive
Contact: Mr. William S. McCallum
Raynham, MA 02767
- Director of Requlatory and Quality Systems (508) 824-2444 (voice) (508) 822-6030 (fax)
FEB 14 23
| Proprietary Name: | Apex Knee System Porous Coated Femoral Components |
|---|---|
| Common Name: | Total Knee Replacement Prosthesis |
| Classification Names: | Prosthesis, knee, patellofemorotibial, semi-constrained, |
| cemented, polymer/metal/polymer | |
| Prosthesis, knee, patellofemorotibial, semi-constrained, | |
| uncemented, polymer/metal/polymer | |
| Regulatory Classes: | Class II per 21 CFR §888.3560 |
| Class II (special controls) per 21 CFR §888.3565 | |
| Product Codes: | JWH, MBH |
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, with the option of using a porous coated femoral component for uncemented or cemented fixation. 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 Porous Coated Femoral Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome femoral components have a sintered porous coating (ASTM F1377). Fixation of the femoral component is achieved using either PMMA bone cement or by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System consists of a range of sizes of 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 sizefor-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 Apex Knee System (K060192), distributed by OMNI life science, Inc., and the Sigma Cruciate-Retaining Porocoat® Femoral Components distributed by DePuy Orthopedics (K062654). The following table summarizes the similarities and differences between the subject uncemented femoral components of the Apex Knee System and these predicate devices:
| | Apex Knee
Porous Coated
Femoral
Components | Apex Knee
Cemented
Femoral
Components
(K060192) | Sigma*
Porocoat®
Femoral
Components
(K062654) |
|-----------------------------|-----------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision, 3 | Yes, cemented or | Yes, cemented | Yes, cemented or |
| compartment | uncemented | | uncemented |
| DESIGN | | | |
| Porous coated | Yes | No | Yes |
| Asymmetric femur, | Yes | Yes | Yes |
| anatomic patella groove | | | |
| Anatomic (asymmetric) | Yes | Yes | No |
| tibial tray | | | |
| Metal-backed UHMWPE | Yes | Yes | Yes |
| tibial component | | | |
| Tibial insert designs | CR and Ultra | CR and Ultra | CR ("Curved") |
| Tibial tray distal features | Central post and | Central post and | Central post and 2 |
| | 2 keels | 2 short keels | short keels |
| Patella design | Round, single | Round, single | Round, single |
| | radius dome, 3 | radius dome, 3 | radius dome, 3 |
| | pegs | pegs | pegs |
| MATERIALS | | | |
| Femoral component | Cobalt chrome | Cobalt chrome | Cobalt chrome |
| Femoral porous coating | Yes, sintered | No | Yes, sintered |
| | cobalt chrome | | cobalt chrome |
The only change to the Sponsor's predicate Apex Knee System (K060192) is the addition of a sintered cobalt chrome porous coating to the femoral components. This porous coating is similar to the sintered cobalt chrome porous coating on the predicate DePuy femoral components, and has the same bead configuration (sizes and shapes) as the Sponsor's Apex Modular Acetabular Cup (K031110). All other materials, designs, and manufacturing, packaging, and sterilization methods are identical to the predicate Apex Knee System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular fashion around the eagle.
Public Health Service
FEB 14 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OMNI life science, Inc. % Mr. William McCallum Director, Regulatory and Quality 175 Paramount Drive, Suite 302 Raynham, Massachusetts 02767
Re: K073602
Trade/Device Name: Apex Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, MBH Dated: January 25, 2008 Received: January 28, 2008
Dear Mr. McCallum:
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
3
Page 2 - Mr. William McCallum
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 legally marketed predicate device results in a classification for your device and thus, permits 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073602
Device Name: OMNI life science 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 fixation, with the option of using a porous coated femoral component for uncemented or cemented fixation. 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; .
- Congenital dislocation; ●
- 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)
Chubare BouellD
Page 1 of 1
Restorative, Division of Ge and Neurological Devices
510(k) Number K073602