(56 days)
Not Found
No
The summary describes a mechanical knee replacement system and does not mention any AI or ML components.
Yes
The device is a total knee replacement system intended to treat various joint diseases and deformities, thereby alleviating symptoms and restoring function.
No
This device is described as a "total knee replacement" system, which is a prosthetic intended for surgical implantation to replace a diseased or damaged knee joint. Its purpose is to correct functional deformity and replace failed joints, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical knee replacement system with components like femoral components, tibial inserts, and augments, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Apex Knee™ System is a total knee replacement prosthesis. This is a surgical implant used to replace a damaged knee joint.
- Device Description: The description details the components of the prosthesis (femoral component, tibial inserts, tibial augments) and their function in providing stability and constraint within the knee joint.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Clinical Context: The device is intended for surgical implantation to treat conditions affecting the knee joint.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body to restore function.
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). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The posterior stabilized system offers a femoral component and two tibial inserts (PS (K102578) and PS-C (subject device)) offering different levels of constraint. The PS-C Insert post is approximately 1 mm larger than the PS Insert (K102578). The slightly larger post is designed to produce more varus/valgus and internal/external rotational constraint.
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)
Non-Clinical Test Summary: The following tests were conducted: ROM evaluation per ASTM F2083-08, FDA " Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA" Tibio-Femoral Constraint per ASTM F2083-08, ASTM F1223-03.
Clinical Test Summary: No clinical studies were performed.
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
§ 888.3560 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
Image /page/0/Picture/0 description: The image shows two symbols or characters written in what appears to be black ink on a white background. The symbol on the left resembles a number sign or hashtag. The symbol on the right looks like a vertical line with a loop or curve extending to the right from its lower portion.
510(K) Summary
JUN 2 2 2011
06 June, 2011 Apex PS Knee System Radhika Pondicherry Submitter OMNIlife science, Inc. Contact Regulatory Affairs 50 O'Connell Way 774-226-1852 E. Taunton MA 02718 (508) 822-6030 (fax) Preparation 06 June,2011 Date Apex PS Knee System, PS-C Insert Device Name Sizes 1 thru 6 available in 6 thicknesses for each respective Insert size. Sizes Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Common Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis. name/ Classification Class II per 21 CFR § 888.3565, 888.3560 Regulatory Class Product Code 21 CFR Product Code-MBH , JWH Legally Apex PS Knee System K102578 Marketed Predicate Device(s) Device The posterior stabilized system offers a femoral component and two tibial inserts (PS Description (K102578) and PS-C (subject device)) offering different levels of constraint. The PS-C Insert post is approximately 1 mm larger than the PS Insert (K102578). The slightly larger post is designed to produce more varus/valgus and internal/external rotational constraint The Apex Knee™ System is intended for use as a primary or revision total knee replacement. Indications for This prosthesis may be used for the following conditions, as appropriate: Use 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). All other femoral, tibial baseplate and patellar components are indicated for cemented use onlv. The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
1
KIIII1184*2/2
7
Predicate Device Comparison
:
| | Apex PS Knee System PS-C
Insert
(subject device) | Apex PS Knee System,
PS Insert
(K12578) |
|-----------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | |
| Priary and revision total knee
replacement | Yes | Yes |
| Design | | |
| Post Width | 16 -21 mm depending on size | 15 -20 mm depending on size |
| Varus/ Valgus Constraint | $3 - 4^\circ$ | No Varus/Valgus Constraint |
| Intenal/ External Rotation | 11 - 17 ° | 14 - 20 ° |
| Range Of Motion | Idntical to K102578 | 6° hyperextension and 132 °
flexion |
| Condyle Geometry and Contact Area | Identical geometry to
K102578 | Toroidal convex femoral
surface and a toroidal concave
insert surface with medial-
lateral and anterior-postrior
radii that increase wth
component size |
| Tibia Baseplate Mating feature | Identical to K102578 | Mates with two parallel
dovetail rails on Tibia
Baseplate. |
| Materials | | |
| Ultra high molecular weight
polyethylene | Identical to K102578 | UHMWPE ASTM F648 |
| PACKAGING AND STERILIZATION | | |
| Sterilization | Identical to K102578 | Ethylene oxide |
| SAL | Identical to K102578 | $10^6$ |
| Packaging | Identical to K102578 | Paper Board Box, Double
Tyvek inner pouch |
| Non-Clinical
Test Summary | The following tests were conducted:
ROM evaluation per ASTM F2083-08, FDA " Class II Special Controls Guidance Document:
Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated
Uncemented Prostheses; Guidance for Industry and FDA" Tibio-Femoral Constraint per ASTM F2083-08, ASTM F1223-03 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test
Summary | No clinical studies were performed. |
| Conclusions | In summary, the Apex PS Knee System PS-C Insert, in our opinion, is substantially equivalent to
the predicate device. |
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-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OMNIlife science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs 50 O'Connell Way East Taunton, Massachusetts 02718
Re: K111184
JUN 2 2 2011
Trade/Device Name: Apex PS 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, MBH Dated: June 6, 2011 Received: June 7, 2011
Dear Ms. Pondicherry:
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 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
3
Page 2 - Ms. Radhika Pondicherry
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 11 you doshe specific aa weboutFDA/CentersOffices/CDRH/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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for Pete O R
CLIN 080 UR
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Hcalth
Enclosure
4
Indications for Use
510(k) Number (if known):
【
Device Name: Apex PS Knee System
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}. All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
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)
Page 1 of 1
for M. Mellekson
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111184