(99 days)
The DePuy Attune™ Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
The Attune™ posterior stabilized (PS) femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is textured. It incorporates two lugs (pegs) to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune PS fixed bearing tibial insert is designed with a topography that, in the sagittal view, consists of multiple radii. The sagittal anterior radii are relatively conforming to the femoral component to aid in anterior constraint while the posterior radius is less conforming to allow rollback. The Attune PS fixed bearing tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. The inserts are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The Attune PS femoral components and PS fixed bearing inserts are compatible with the Attune FB tibial bases (K101433) and patellae (K103756). The Attune PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.
This document is a 510(k) premarket notification for a medical device, specifically the DePuy Attune Total Knee System – PS Femoral Components and PS Fixed Bearing Inserts. It does not describe a study involving algorithms, AI, or human-in-the-loop performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional testing for mechanical properties.
Therefore, many of the requested categories related to AI/algorithm performance and clinical studies are not applicable to this document.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria or reported performance metrics in a readily comparable table format for each characteristic against a defined threshold. Instead, it states that "Functional testing was conducted... to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via various constraint, contact, wear, and fatigue tests." This implies the acceptance criterion was "substantially equivalent" to predicate devices, and the reported performance met this criterion.
| Characteristic | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Performance | Substantially equivalent to predicate devices for anticipated in vivo loading (via constraint, contact, wear, and fatigue tests). | Verified as substantially equivalent to predicate devices through non-clinical functional testing. |
| Material (Femoral) | Cast Co-Cr-Mo alloy conforming to ASTM F75 (same as predicate) | Cast Co-Cr-Mo alloy conforming to ASTM F75 |
| Material (Tibial) | AOX UHMWPE conforming to ASTM F648 (same as predicate) | AOX UHMWPE conforming to ASTM F648 |
| Sizes (Femoral) | Sizes 1-10 standard, Left/Right; Sizes 3-6 narrow, Left/Right; Proportional Sizing (same as predicate) | Sizes 1-10 standard, Left/Right; Sizes 3-6 narrow, Left/Right; Proportional Sizing |
| Sizes (Tibial) | Proportional sizing, sizes 1-10, various thicknesses (similar to predicate) | Proportional sizing, sizes 1-10, thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. |
| Fixation Surface | Cemented (same as predicate) | Cemented |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as this was non-clinical functional testing, not a clinical study with patient samples. The "test set" would refer to the physical components tested in a lab.
- Data Provenance: The testing was conducted by DePuy Orthopaedics, Inc. in Warsaw, IN, USA. It is non-clinical (laboratory) data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood in AI/algorithm studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for non-clinical functional testing is based on engineering specifications, material standards (e.g., ASTM F75, ASTM F648), and design parameters, which are evaluated by engineers and technical staff during the testing process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human expert disagreements in interpreting data, which is not relevant for non-clinical mechanical testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a 510(k) for a knee replacement system, not an AI or imaging diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" or reference for this device's performance is based on engineering standards (ASTM F75, ASTM F648), pre-defined design specifications, and the performance characteristics of predicate devices as demonstrated through established non-clinical functional tests (constraint, contact, wear, and fatigue tests).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this type of device.
{0}------------------------------------------------
K111M33 #'/4
AUG 3 0 2011
Summary of Safety and Effectiveness Attune Total Knee System – PS Femoral Components and PS Fixed Bearing Inserts DePuy Orthopaedics
ﻟﻤﺴﺎﻋ
| Submitted by: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (574) 371-4923Fax: (574) 371-4987 |
|---|---|
| Contact Person: | Nancy Friddle, Project Manager Regulatory Affairs |
| Date Prepared: | May 16, 2011 |
| Proprietary Name: | DePuy Attune™ Knee System |
| Common Name: | Total Knee Replacement Prosthesis |
| Classification Name: | 21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis.Class II |
| Product Code: | JWHOIY |
| Predicate Devices: | The DePuy Attune PS Femoral Components and PS Fixed BearingInserts, which are part of the DePuy Attune Knee System, aresubstantially equivalent to currently marketed devices including:• Attune Knee System, K101433• Sigma Tibial Inserts, K033272• Sigma XLK Tibial Inserts, K040166• Sigma PS Femoral Components, K073529• Zimmer NexGen LPS Femoral Components / ArticularSurfaces, K960279 |
| Device Description: | The Attune™ posterior stabilized (PS) femoral components have anasymmetric trochlear groove and are available in sizes 1-10 in rightand left options. Sizes 3-6 are available in standard and narrowoptions. The fixation surface is textured. It incorporates two lugs(pegs) to provide additional stability and recessed cement pockets forenhanced cement fixation. The Attune femoral components aremanufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. |
| The Attune PS fixed bearing tibial insert is designed with atopography that, in the sagittal view, consists of multiple radii. Thesagittal anterior radii are relatively conforming to the femoralcomponent to aid in anterior constraint while the posterior radius isless conforming to allow rollback. The Attune PS fixed bearing tibialinserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10,12, 14, 16, 18, 20, and 22mm. The inserts are manufactured fromAOX ultra high molecular weight polyethylene conforming to ASTMF648. | |
| The Attune PS femoral components and PS fixed bearing inserts arecompatible with the Attune FB tibial bases (K101433) and patellae(K103756). | |
| The Attune PS Total Knee is designed to accommodate knee flexionto 145 degrees in those patients able to attain a high degree of kneeflexion. | |
| Intended Use: | Total knee replacement is intended to provide increased patientmobility and reduced pain by replacing the damaged knee jointarticulation in patients where there is evidence of sufficient soundbone to seat and support the components. |
| The Attune PS Total Knee is intended to accommodate knee flexionto 145 degrees in those patients able to attain a high degree of kneeflexion. | |
| Indications for Use: | As part of the DePuy Attune Knee System, the DePuy Attune PSfemoral components and tibial inserts are intended for cemented useas a total knee replacement system.Candidates for total knee replacement include patients with a severelypainful and/or severely disabled joint resulting from osteoarthritis,post-traumatic arthritis, rheumatoid arthritis, or a failed previousimplant. |
| TechnologicalCharacteristics: | As shown in the following tables, the technological characteristics ofthe Attune PS femoral components and tibial inserts are similar tothe predicate devices including design and material. |
・
{1}------------------------------------------------
K1114.33 *2/4
| Characteristic | Attune PS FemoralComponent | Attune CR FemoralComponent (K101433) |
|---|---|---|
| Material | Cast Co-Cr-Mo alloyconforming to ASTM F75 | Cast Co-Cr-Mo alloyconforming to ASTM F75 |
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the text "K111433 *3/4". The text is written in a handwritten style. The numbers are written in a clear and legible manner.
| Characteristic | Attune PS FemoralComponent | Attune CR FemoralComponent (K101433) |
|---|---|---|
| Sizes | Sizes 1 to 10 standard, Leftand Right | Sizes 1 to 10 standard, Leftand Right |
| Sizes 3-6 narrow, Left andRight | Sizes 3-6 narrow, Left andRight | |
| Proportional Sizing | Proportional Sizing | |
| FixationSurface | Cemented | Cemented |
| Characteristic | Attune PS Fixed BearingTibial Inserts | Attune CR Fixed BearingTibial Inserts (K101433) andSigma Tibial Inserts(K033272) |
|---|---|---|
| Material | AOX UHMWPE conformingto ASTM F648 | Attune CR: AOX UHMWPEconforming to ASTM F648 |
| Sizes | Proportional sizingPS inserts, sizes 1 to 10Actual thicknesses 5, 6, 7, 8,10, 12, 14, 16, 18, 20, and22mm. | Attune CR:Proportional sizingCR inserts, sizes 1 to 10Actual thicknesses 5, 6, 7, 8,10, 12, 14, 16, and 18mm.Sigma Stabilized:Constant sizingStabilized inserts, sizes 1.5 to 6Composite thicknesses 8, 10,12.5, 15, 17.5, 20, 22.5 and25mm. |
Summary of Substantial Equivalence:
The DePuy Attune Total Knee System is substantially equivalent to currently marketed devices as demonstrated with preclinical data.
{3}------------------------------------------------
K111433*4/4
Non-Clinical Testing:
Functional testing was conducted in compliance with FDA guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA, to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via various constraint, contact, wear, and fatigue tests.
Clinical Testing:
None provided as it was not necessary to determine substantial equivalence between the Attune Knee System's PS femoral and PS fixed bearing insert components and the predicate devices.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Inc. % Ms. Nancy Friddle 700 Orthopaedic Drive Warsaw, Indiana 46581
AUG 3 0 2011
Re: K111433 Trade/Device Name: DePuy Attune™ 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: OIY, JWH Dated: August 10, 2011 Received: August 11, 2011
Dear Ms. Friddle:
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
{5}------------------------------------------------
Page 2 - Ms. Nancy Friddle
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/ReportalProblem/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,
urs,
For Pati
Der
Cli
B.N
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
2. INDICATIONS FOR USE
KU11433 510(k) Number (if known): _
Device Name: DePuy Attune™ PS Knee System
Indications for Use:
The DePuy Attune™ Knee System is intended for cemented use as a total knee replacement system.
Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteo.arthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Prescription Use __ X (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)
Page 1 of 1
for M.Mellerson
(Division Sign-Oft) (Division Sign-on) )
Division of Surgical, Orthopedic, Division of Surgices
510(k) Number K111433.
§ 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.