(86 days)
Not Found
No
The summary describes a physical knee implant component and its intended use and materials. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes.
The device is an implantable prosthesis used for total knee replacement to treat degenerative joint diseases and deformities, which is a therapeutic intervention.
No
The device description clearly states it is part of a total knee implant system used for joint replacement, which is a therapeutic intervention, not a diagnostic process.
No
The device description clearly states it is a physical implant made from Ultra High Molecular Weight Polyethylene (UHMWPE) and is intended for surgical implantation as part of a total knee replacement. It is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Apex All Poly Tibia is a physical implant designed to be surgically placed within the knee joint. It is a prosthetic component used in total knee replacement surgery.
- Intended Use: The intended use is to replace damaged parts of the knee joint due to various conditions. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The information clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Apex All Poly Tibia is used as part of a primary or revision cemented total knee implant using established total knee arthroplasty procedures. The All Poly Tibia is intended for use with bone cement, single use implantation and for use only with the Apex Knee™ System Femoral and Patella components. The device is machined from compression molded Ultra High Molecular Weight Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock tibia and designed for posterior cruciate substitution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Skeletally mature patients.
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 The following tests were conducted:
- FEA Contact Stress Testing
- Stress Analysis
- Peg Stiffness Analysis
- Cement Mantle Stress Analysis
- FEA Abrasive Wear
- Insert Contact Pressure and Contact AreaTesting (ASTM F2083-08)
All samples tested met the acceptance criteria.
Clinical Test 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
K111062
p11/2
·
JUL 1 3 2011
Appendix B 510(k) Summary
| Submitter Name | OMNIlife science, Inc.
50 O'Connell Way
Suite #10
East Taunton, MA 02718 | Contact: Christine Nassif
Regulatory Affairs
Phone: 774-226-1871
Fax: 508.822.6030 | | Apex All Poly Tibia
(subject device) | Smith & Nephew
Genesis II Total
Knee System
[K002740] | Apex Knee™ System
[K060192] |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Submission Date: | July 11, 2011 | | Body Site | Knee | Knee | Knee |
| Trade Name | The Apex Knee System, Apex All Poly Tibia | | Intended Use | Primary or revision
total knee
replacement
(cemented) | Primary or revision
total knee
replacement
(cemented) | Primary or
revision total
knee
replacement
(cemented
for Ultra
Congruent) |
| Classification
Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented
prosthesis | | Patient Population | Skeletally mature
patients. | Skeletally mature
patients. | Skeletally mature
patients. |
| Regulatory Class | Class II per 21 CFR § 888.3560 | | Similar Design and Specifications | | | |
| Product Code | JWH | | Device Design
[component] | All Polyethylene
Tibia | All Polyethylene
Tibia | Apex Knee™ System
- Ultra Congruent
Tibial Component:
Tibial insert
Tibial Baseplate
(asymmetrical) |
| Device
Description | The Apex All Poly Tibia is used as part of a primary or revision cemented total knee
implant using established total knee arthroplasty procedures. The All Poly Tibia is
intended for use with bone cement, single use implantation and for use only with the
Apex Knee™ System Femoral and Patella components. | | Sterility | Ethylene oxide
SAL 10-6
Residuals: ISO
10993-7 | Ethylene oxide | Ethylene oxide
SAL 10-6
Residuals:
ISO 10993-7 |
| | The device is machined from compression molded Ultra High Molecular Weight
Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock
tibia and designed for posterior cruciate substitution. | | Shelf Life | 5 years from date of
manufacture | Not Available | 5 years from date of
manufacture |
| Indications for
Use | The Apex Knee™ System, Apex All Poly Tibia: | | | MATERIALS and Standards | | |
| | The Apex All Poly Tibia is intended for use as part of a primary or revision total knee
replacement. This prosthesis may be used for the following conditions, as appropriate: | | Tibia Component(s) | Machined from
compression molded
UHMWPE (ASTM
F648) | UHMWPE ( ASTM
F648) | Machined from
compression molded
UHMWPE(ASTM
F648)
CoCr Baseplate |
| | • 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella
components. The Apex All Poly Tibia is indicated for cemented use only. | | | | | |
| Legally Marketed
Predicate
Device(s) | • Smith & Nephew Genesis II Total Knee System, K002740
• Apex Knee™ System, K060192 | | | | | |
1
KIII062
p2/2
Predicate Device Comparison
Non Clinical The following tests were conducted:
- · FEA Contact Stress Testing
- Stress Analysis
- Peg Stiffness Analysis
- · Cement Mantle Stress Analysis
- FEA Abrasive Wear
- Insert Contact Pressure and Contact AreaTesting (ASTM F2083-08)
All samples tested met the acceptance criteria.
Clinical Test No clinical studies were performed.
Summary
Test Summary
- The Apex Knee™ System, Apex All Poly Tibia is substantially equivalent to the predicate Conclusion devices.
2
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 depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. 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. Christine Nassif Director, Regulatory Affairs 50 O'Connell Way. Suite #10 E. Taunton, Massachusetts 02767
JUL 13 2011
Re: K111062
Trade/Device Name: Apex Knee System, Apex All Poly Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH
Dated: April 15, 2011 Received: April 18, 2011
Dear Ms. Nassif:
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
3
Page 2 - Ms. Christine Nassif
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 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 go to http://www.fda.gov/AboutFDA/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix A
Indications for Use Statement
510(k) Number: (if known): K111062
Device Name: Apex Knee™ System, Apex All Poly Tibia
Indications for Use
The Apex Knee™ System, Apex All Poly Tibia:
The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 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)
for M.meikarn
(Division Sign (Off) (Division Signical, Orthopedic, Divisionen Surges and Restorative Devices
510(k) Number_