(56 days)
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.
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.
The provided text describes a 510(k) summary for the Apex PS Knee System PS-C Insert and its comparison to a predicate device, the Apex PS Knee System, PS Insert (K102578). The document focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical studies using patient data. Therefore, many of the requested categories related to clinical study design, such as sample size, expert ground truth, and reader studies, are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating that the subject device's performance characteristics are either identical to or within acceptable variations of the predicate device, as determined by specific ASTM standards. No explicit numerical "acceptance criteria" are stated for performance metrics in the table; rather, the subject device's design and mechanical properties are compared to the predicate.
| Characteristic | Predicate Device (Apex PS Knee System, PS Insert - K102578) | Subject Device (Apex PS Knee System PS-C Insert) | Comparison / Performance |
|---|---|---|---|
| Intended Use | Primary and revision total knee replacement | Yes | Identical intended use. |
| Design: Post Width | 15 - 20 mm depending on size | 16 - 21 mm depending on size | Slightly larger post (approx. 1mm larger) in the subject device, designed to produce more varus/valgus and internal/external rotational constraint. |
| Design: Varus/Valgus Constraint | No Varus/Valgus Constraint | 3 - 4° | Subject device shows added varus/valgus constraint compared to the predicate, as designed. |
| Design: Internal/External Rotation | 14 - 20° | 11 - 17° | Subject device shows a narrower range of internal/external rotation compared to the predicate, indicating increased rotational constraint, as designed. |
| Design: Range of Motion | 6° hyperextension and 132° flexion | Identical to K102578 | Identical. |
| Design: Condyle Geometry and Contact Area | Toroidal convex femoral surface and a toroidal concave insert surface with medial-lateral and anterior-posterior radii that increase with component size | Identical geometry to K102578 | Identical. |
| Design: Tibia Baseplate Mating Feature | Mates with two parallel dovetail rails on Tibia Baseplate. | Identical to K102578 | Identical. |
| Materials | UHMWPE ASTM F648 | Identical to K102578 | Identical Ultra high molecular weight polyethylene (UHMWPE ASTM F648). |
| Packaging & Sterilization | Ethylene oxide, SAL 10^-6^, Paper Board Box, Double Tyvek inner pouch | Identical to K102578 | Identical. |
| Non-Clinical Test Summary | 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 | N/A (Tests conducted on subject device) | The tests were conducted to demonstrate the subject device's performance against the established standards (ASTM F2083-08, ASTM F1223-03) and FDA guidance, allowing for comparison of its characteristics (like varus/valgus and rotational constraint) against the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of devices or units tested. The document refers to "the following tests were conducted," implying a sufficient number of samples were used for the mechanical tests to be representative and meet the requirements of the ASTM standards.
- Data Provenance: Not applicable as no clinical data (patient data) was used. The tests were non-clinical, likely bench testing performed by the manufacturer or a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: No clinical studies were performed, and thus no "ground truth" based on expert medical evaluation of patient data was established for a test set. The "ground truth" for non-clinical testing refers to the accepted standards (ASTM F2083-08, ASTM F1223-03) and FDA guidance.
4. Adjudication Method for the Test Set
- Not Applicable: No human review or adjudication of clinical outcomes was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: No MRMC study was performed. The evaluation was based on non-clinical, mechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This device is a mechanical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Standards and Guidance: The "ground truth" or reference for performance was established by recognized industry standards (ASTM F2083-08, ASTM F1223-03) and FDA guidance documents specific to knee joint prostheses. These standards define the methods and expected performance characteristics for evaluating such devices.
8. The Sample Size for the Training Set
- Not Applicable: No training set was used as this involved mechanical testing of a physical device, not an AI or algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: No training set was used.
{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-CInsert(subject device) | Apex PS Knee System,PS Insert(K12578) | |
|---|---|---|
| Intended Use | ||
| Priary and revision total kneereplacement | 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 toK102578 | Toroidal convex femoralsurface and a toroidal concaveinsert surface with medial-lateral and anterior-postriorradii that increase wthcomponent size |
| Tibia Baseplate Mating feature | Identical to K102578 | Mates with two paralleldovetail rails on TibiaBaseplate. |
| Materials | ||
| Ultra high molecular weightpolyethylene | 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, DoubleTyvek inner pouch |
| Non-ClinicalTest 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-CoatedUncemented Prostheses; Guidance for Industry and FDA" Tibio-Femoral Constraint per ASTM F2083-08, ASTM F1223-03 |
|---|---|
| Clinical TestSummary | No clinical studies were performed. |
| Conclusions | In summary, the Apex PS Knee System PS-C Insert, in our opinion, is substantially equivalent tothe 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
§ 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.