(59 days)
Not Found
No
The description focuses solely on the mechanical components and materials of a knee replacement system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is a total knee replacement system intended to treat conditions like osteoarthritis and rheumatoid arthritis, which are considered therapeutic interventions.
No
Explanation: The Apex Knee System is a total knee replacement prosthesis, which is a therapeutic device used to replace a joint, not to diagnose a condition.
No
The device description clearly describes physical components made of cobalt chrome, titanium, and UHMWPE, intended for surgical implantation as a total knee replacement. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total knee replacement surgery to treat various knee conditions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (knee prosthesis) made of various materials like cobalt chrome, titanium, and UHMWPE. It is designed to replace damaged knee joint components.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The Apex Knee System is a surgical implant used for orthopedic reconstruction.
N/A
Intended Use / Indications for Use
The Apex Knee System is intended for use as a primary or revision total knee replacement. 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. .
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
The Apex Knee System Porous Coated Tibial Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome tibial components have a plasma sprayed CP titanium porous coating (ASTM F1580) with a plasma sprayed overcoat of hydroxyapatite (ASTM F1185), and are intended for use without bone cement. Fixation of the porous coated tibial component is achieved by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System includes a tibial component option with two holes for supplemental fixation using cancellous bone screws, and the same 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 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.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
MAY 2 3 2008
Apex Knee System
- Submitter: OMNI life science™, Inc. 175 Paramount Drive
Raynham, MA 02767
April 16, 2008
Contact: Mr. William S. McCallum Director of Regulatory and Quality Systems (508) 824-2444 (voice) (508) 822-6030 (fax)
2. Device Name
| Proprietary Name: | Apex Knee System Porous Coated Tibial 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 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. .
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
4. Device Description
The Apex Knee System Porous Coated Tibial Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome tibial components have a plasma sprayed CP titanium porous coating (ASTM F1580) with a plasma sprayed overcoat of hydroxyapatite (ASTM F1185), and are intended for use without bone cement. Fixation of the porous coated tibial component is achieved by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System includes a tibial component option with two holes for supplemental fixation using cancellous bone screws, and the same 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 size-for-size match to the femoral component. There are two different articular geometries for
1
K080842 *2/2
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.
5. Predicate Device Comparison
Substantial equivalence is claimed to the Apex Knee System (K060192 and K073602) and the Apex Modular™ HA Hip Stem (K043123), distributed by OMNI life science, Inc. The following table summarizes the similarities and differences between the subject uncemented tibial components of the Apex Knee System and these predicate devices:
| | Apex Knee
Porous Coated
Tibial
Components | Apex Knee
System
(K060192 and
K073602) | Apex Modular™
HA Hip Stem
(K043123) |
|---------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------|
| INTENDED USE | | | |
| Primary and revision, 3
compartment knee | Yes, cemented or
uncemented
(porous coated
tray: uncemented
only) | Yes, cemented
(porous coated
femoral:
cemented or
uncemented) | Yes, uncemented
(THA) |
| DESIGN | | | |
| Anatomic (asymmetric)
tibial tray | Yes | Yes | N/A |
| Metal-backed UHMWPE
tibial component | Yes | Yes | N/A |
| Tibial insert designs | CR and Ultra | CR and Ultra | N/A |
| Screw holes | None or two | None | N/A |
| Tibial tray distal features | Central post and
2 keels | Central post and
2 keels | N/A |
| MATERIALS | | | |
| Tibial component | Cobalt chrome | Cobalt chrome | N/A |
| Porous coating | Plasma sprayed
CP titanium with
HA overcoat
(tibial tray) | No (tibial tray) | Plasma sprayed
CP titanium with
HA overcoat (hip
stem) |
The only change to the Sponsor's predicate Apex Knee System (K060192 and K073602) is the addition of a plasma sprayed CP titanium porous coating with a plasma sprayed overcoat of hydroxyapatite (ASTM F1185) to the tibial components, and the addition of a tibial tray option with the same porous coating and two holes for supplemental fixation using cancellous bone screws. This porous coating is identical to the plasma sprayed CP titanium and hydroxyapatite porous coating on the Sponsor's Apex Modular™ HA Hip Stem (K043123, February 10, 2005). 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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2008
OMNIlife Science % Bill McCallum 175 Paramount Drive Raynham, MA 02767
K080842 Re: Trade/Device Name: Apex Knee System, Model KC-230XY, KC-240XY [no holes, 2 holes] Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: April 30, 2008 Received: May 02, 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 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.
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Page 2 – Bill McCallum
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Mark H. Miller
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):
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 knec replacement. 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. ●
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
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)
Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
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510(k) Num