(99 days)
Not Found
No
The description focuses on the mechanical design and materials of the knee replacement system, with no mention of AI or ML capabilities.
Yes
The device is a total knee replacement system intended for patients with severely painful and/or disabled knee joints, indicating its use for restoring function and alleviating symptoms.
No
This device is a total knee replacement system, which is a prosthetic implant used in surgery, not a device for diagnosing medical conditions.
No
The device description clearly outlines physical components made of materials like Co-Cr-Mo alloy and polyethylene, indicating it is a hardware medical device (a total knee replacement system).
No, 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 provided text describes a total knee replacement system, which is an implantable medical device used to replace a damaged knee joint. It is a physical device implanted within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for "cemented use as a total knee replacement system" for patients with joint issues. This is a surgical intervention, not a diagnostic test.
The information provided describes a Class II medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / 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 osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
Product codes (comma separated list FDA assigned to the subject device)
JWH, OIY
Device Description
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.
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 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.
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.
K101433, K033272, K040166, K073529, K960279
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
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 Drive
Warsaw, IN 46581
Phone: (574) 371-4923
Fax: (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 patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis.
Class II |
| Product Code: | JWH
OIY |
| Predicate Devices: | The DePuy Attune PS Femoral Components and PS Fixed Bearing
Inserts, which are part of the DePuy Attune Knee System, are
substantially 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 / Articular
Surfaces, K960279 |
| Device Description: | 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. |
| Intended Use: | Total knee replacement is intended to provide increased patient
mobility and reduced pain by replacing the damaged knee joint
articulation in patients where there is evidence of sufficient sound
bone to seat and support the components. |
| | The Attune PS Total Knee is intended to accommodate knee flexion
to 145 degrees in those patients able to attain a high degree of knee
flexion. |
| Indications for Use: | As part of the DePuy Attune Knee System, the DePuy Attune PS
femoral components and tibial inserts are 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. |
| Technological
Characteristics: | As shown in the following tables, the technological characteristics of
the Attune PS femoral components and tibial inserts are similar to
the predicate devices including design and material. |
・
1
K1114.33 *2/4
| Characteristic | Attune PS Femoral
Component | Attune CR Femoral
Component (K101433) |
|----------------|-----------------------------------------------|-----------------------------------------------|
| Material | Cast Co-Cr-Mo alloy
conforming to ASTM F75 | Cast Co-Cr-Mo alloy
conforming 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 Femoral
Component | Attune CR Femoral
Component (K101433) |
|---------------------|-------------------------------------------|-------------------------------------------|
| Sizes | Sizes 1 to 10 standard, Left
and Right | Sizes 1 to 10 standard, Left
and Right |
| | Sizes 3-6 narrow, Left and
Right | Sizes 3-6 narrow, Left and
Right |
| | Proportional Sizing | Proportional Sizing |
| Fixation
Surface | Cemented | Cemented |
| Characteristic | Attune PS Fixed Bearing
Tibial Inserts | Attune CR Fixed Bearing
Tibial Inserts (K101433) and
Sigma Tibial Inserts
(K033272) |
|----------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | AOX UHMWPE conforming
to ASTM F648 | Attune CR: AOX UHMWPE
conforming to ASTM F648 |
| Sizes | Proportional sizing
PS inserts, sizes 1 to 10
Actual thicknesses 5, 6, 7, 8,
10, 12, 14, 16, 18, 20, and
22mm. | Attune CR:
Proportional sizing
CR inserts, sizes 1 to 10
Actual thicknesses 5, 6, 7, 8,
10, 12, 14, 16, and 18mm.
Sigma Stabilized:
Constant sizing
Stabilized inserts, sizes 1.5 to 6
Composite thicknesses 8, 10,
12.5, 15, 17.5, 20, 22.5 and
25mm. |
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.