(291 days)
No
The summary describes a mechanical knee replacement system and its components, with no mention of AI or ML technology in its design, function, or testing.
Yes
The device is a knee replacement system intended to treat conditions such as degenerative joint disease and rheumatoid arthritis, which are health-related conditions that require medical intervention.
No
Explanation: The device is a total knee replacement system, which is a therapeutic device intended to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly outlines physical components made of Cobalt Chrome and polyethylene, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Apex Knee™ System is a total knee replacement prosthesis. It is an implantable device used to replace a damaged knee joint.
- Intended Use: The intended use is for primary and revision total knee replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and functional deformities. This involves surgical implantation into the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes based on in vitro analysis.
Therefore, the Apex Knee™ System is a surgical implant, not an In Vitro Diagnostic device.
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 (biological fixation).
The porous coated tibial baseplate is to be used uncemented (biological fixation).
All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to the Tibia baseplate and cemented to the prepared tibia.
Product codes
JWH, MBH
Device Description
The proposed devices are intended to be used for primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining
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)
Non-clinical testing specifically for the Pegged Porous Coated Cementless Tibial Baseplates include FEA simulation and peg location templating study.
The results of the testing show that the Apex Knee Pegged Porous Coated Cementless Tibial Baseplates are safe and effective for the proposed indications and is substantially equivalent to the predicate devices.
Non-clinical testing was conducted specifically for the ECiMa Tibial Inserts & Patellae. These tests include:
• material characterization,
• PS post strength testing,
• insert disassembly strength testing,
• wear testing.
Biological testing of the ECiMa material was conducted for biocompatibility. These tests include:
• intramuscular implantation in animal models,
• implant toxicity and subcutaneous implantation in animal models.
The results of the testing show that the Apex Knee ECiMa Tibial Inserts & Patellae are safe and effective for the proposed indications and is substantially equivalent to the predicate devices.
The conclusions drawn from the nonclinical tests demonstrate that the devices are safe, as effective, and perform as well as or better than the legally marketed device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OMNI TiN Coated Apex Knee™ System- K191765
Reference Device(s)
K060192, K102578, K111184, K112891
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
April 2, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features a stylized depiction of human figures, while the FDA part includes a blue square with "FDA" in white and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OMNIlife science Dipti Dharia Chief Quality, Regulatory, & Clinical Officer 480 Paramount Drive Raynham, Massachusetts 02767
Re: K201611/S001
Trade/Device Name: Apex Knee™ System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: February 19, 2021 Received: March 4, 2021
Dear Dipti Dharia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K201611
Device Name Apex Knee™ System
Indications for Use (Describe)
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 (biological fixation).
The porous coated tibial baseplate is to be used uncemented (biological fixation).
All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to the Tibia baseplate and cemented to the prepared tibia.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for OMNI. The logo consists of a circular graphic on the left and the word "OMNI" on the right. The circular graphic is blue and green and appears to be a stylized representation of a person. Below the word "OMNI" is the phrase "Engineering Orthopaedic Innovation".
510(k) Summary
| TABLE 1: 510(k) SUMMARY | |
|---|---|
| Date Summary Prepared | 06/12/2020 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science |
| 480 Paramount Drive | |
| Raynham, MA 02767 | |
| 510(k) Contact | Dipti Dharia |
| Chief Quality, Regulatory & Clinical Officer | |
| Corin Ltd., | |
| 480 Paramount Drive | |
| Raynham, MA 02767 | |
| Telephone: +1-732-754-5466 | |
| Email: Dipti.Dharia@coringroup.com |
Secondary Contact:
Jack Liang
Senior Regulatory Affairs Specialist
Corin Ltd / Corin Australia
+61 2 9497 7400
Jack.Liang@coringroup.com |
| Trade Name | Apex Knee™ System |
| Common Name | prosthesis, knee, patellofemorotibial, semi-constrained,
cemented, polymer/metal/polymer
prosthesis, knee, patello/femorotibial, semi-constrained,
uncemented, porous, coated |
| Classification | 21 CFR 888.3560. Class II. Knee joint
patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis. JWH
21 CFR 888.3565. Class II. Knee joint
patellofemorotibial metal/polymer porous-coated
uncemented prosthesis. MBH |
| Predicate Device | OMNI TiN Coated Apex Knee™ System- K191765 |
| Purpose of Submission | This traditional 510(k) premarket notification is being
submitted to obtain clearance for the modifications to
the Apex Knee™ System to expand OMNI's product
offering for total knee arthroplasty. |
| 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 is to be used
uncemented (biological fixation).
All other femoral, tibial baseplate, and patellar
components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial
Augments are intended to be bolted to the Tibia
baseplate and cemented to the prepared tibia. |
| Device Description | The proposed devices are intended to be used for
primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional
stability by adding pegs to the posterior end of the
device. The material of the proposed Pegged Tibial
Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from
compression molded highly crosslinked polyethylene
with Vitamin E (VE-XLPE) and attaches to the cobalt
chrome tibial baseplate via dovetails and a retaining |
| Engineering Orthopaedic Innovation | |
| Sterility and Biocompatibility | The proposed devices undergo the same validated
sterilization process, using ethylene oxide (EO), as the
predicate devices (K060192, K102578, K111184,
K112891) under the sterility assurance level (SAL) of
10-6. All ethylene oxide residuals are monitored and
well below standard limits.
In addition, OMNI has developed a plan to test
endotoxins on all OMNIlife science device groups
through Limulus amebocyte lysate (LAL) testing.
Products have been segregated into product families
based on manufacturing process and material type and
have generated 8 product groups that will be tested for
endotoxins on a quarterly basis on a yearly rotation, and
the subject devices are included in one of the product
groups. Product will not be released if the 4 EU/device
limit is exceeded. |
| Substantial Equivalence Summary | The proposed devices with modifications are
substantially equivalent to the existing Apex Knee™
System cleared in K191765 as the basic design,
interface, fundamental technology and intended use are
the same.
The use of the new Apex Knee™ System components
with the existing knee components do not introduce any
new risks of safety or efficacy.
Tibial Baseplate:
In addition to the testing performed for the Apex Knee
System, non-clinical testing specifically for the Pegged
Porous Coated Cementless Tibial Baseplates include
FEA simulation and peg location templating study.
The results of the testing show that the Apex Knee
Pegged Porous Coated Cementless Tibial Baseplates are |
| | safe and effective for the proposed indications and is
substantially equivalent to the predicate devices.
The justifications are described in Section 10, Device
Description. |
| | ECiMa Tibial Inserts & Patellae |
| | In addition to the testing already performed for the Apex
Knee System, non-clinical testing was conducted
specifically for the ECiMa Tibial Inserts & Patellae.
These tests include:
• material characterization,
• PS post strength testing,
• insert disassembly strength testing,
• wear testing. |
| | Biological testing of the ECiMa material was conducted
for biocompatibility. These tests include:
• intramuscular implantation in animal models,
• implant toxicity and subcutaneous implantation in
animal models. |
| | The results of the testing show that the Apex Knee
ECiMa Tibial Inserts & Patellae are safe and effective
for the proposed indications and is substantially
equivalent to the predicate devices. |
| | Based on the design, fundamental technology, material,
intended use and technological characteristics,
OMNIlife science believes the proposed Apex KneeTM
System devices to be substantially equivalent to legally
marketed predicates. |
| Conclusion Statement | The conclusions drawn from the nonclinical tests
demonstrate that the devices are safe, as effective, and
perform as well as or better than the legally marketed
device |
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Image /page/4/Picture/1 description: The image shows the logo for OMNI. The logo consists of a blue and green circular graphic to the left of the word "OMNI" in large, bold, blue letters. Below the word "OMNI" is the text "Engineering Orthopaedic Innovation" in a smaller font size. The logo is clean and professional, and the colors are eye-catching.
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Image /page/5/Picture/1 description: The image shows the logo for OMNI Engineering Orthopaedic Innovation. The logo features a stylized human figure inside of a circle on the left. The word "OMNI" is in large, bold, blue letters to the right of the figure. Below the word "OMNI" is the phrase "Engineering Orthopaedic Innovation" in a smaller font.
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Image /page/6/Picture/1 description: The image shows the logo for OMNI. The logo consists of a blue and green circular design on the left, followed by the word "OMNI" in large, bold, blue letters. Below the word "OMNI" is the text "Engineering Orthopaedic Innovation" in a smaller font.