(73 days)
Not Found
No
The device description focuses on the physical components and materials of knee implants, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to replace severely disabled or painful joints, which is a therapeutic purpose.
No
The device is a knee implant designed for total knee arthroplasty, which is a treatment for joint conditions, not a tool for diagnosis.
No
The device description clearly outlines physical components made of polyethylene and metal, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text clearly describes a device intended for surgical implantation within the human body to replace a damaged knee joint. It is a physical implant used in a surgical procedure, not a test performed on a sample.
The device is a surgical implant used in total knee arthroplasty.
N/A
Intended Use / Indications for Use
The DePuy AMK and Coordinate Ultra Cross-Linked Polyethylene Inserts and Trays are to be used with the currently marketed AMK Total Knee System and/or the Coordinate Ultra Knee Revision System components.
The DePuy AMK Total Knee System and Coordinate Ultra Knee Revision System are intended to be used in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or posttraumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.
Product codes
JWH
Device Description
The subject DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and trays are available in five sizes (1-5) with five thickness' (10, 12, 14, 16, and 18mm) or ten thickness' (10, 12, 14, 16. 18. 20. 22. 24. 26. and 28mm), depending on the specific device, in each size. The cross-linked polyethylene tibial inserts fasten to a metal tibial tray by means of a central pin and interlocking clip or a tibial stabilizing post. The fixative surface of the cross-linked polyethylene tibial trays have a salt-blasted surface, a round central stem, and cloverleaf patterned recesses to enhance cement fixation to the proximal tibia surface. The DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and trays are intended to be used with the currently legally marketed DePuy AMK Total Knee System and/or Coordinate Ultra Knee Revision System in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K864671, K910940, K943299, K954684, K955884, K972596
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
5 1098 OCT
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|----------------------|-------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Sally Foust
Sr.Regulatory Submissions Associate
(219) 372-7455; FAX (219) 267-7098 |
| TRADE NAME: | DePuy AMK® Total Knee System
DePuy Coordinate Ultra™ Knee Revision System |
| COMMON NAME: | Knee Device |
| CLASSIFICATION: | 888.3560 Prosthesis, Knee, PatelloFemorotibial,
Semiconstrained, Cemented, Polymer, Metal, Polymer |
| DEVICE PRODUCT CODE: | 87 JWH |
SUBSTANTIALLY EQUIVALENT DEVICES:
- (DePuy) Anatomic Modular Knee (AMK) System (K864671) ●
- (DePuy)Anatomic Modular Knee (AMK) Polyethylene Tibial Tray (K910940) .
- (DePuy) AMK Polyethylene Posterior Stabilized Tibial Tray (K943299) .
- (DePuy) AMK Congruency Posterior Stabilized Insert (K954684) .
- (DePuy) Coordinate II (Ultra) Knee Revision System (K955884) .
- (DePuy) Duraloc Acetabular Cup System (K972596) t
DEVICE DESCRIPTION-AND INTENDED USE:
The subject DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and trays are available in five sizes (1-5) with five thickness' (10, 12, 14, 16, and 18mm) or ten thickness' (10, 12, 14, 16. 18. 20. 22. 24. 26. and 28mm), depending on the specific device, in each size. The cross-linked polyethylene tibial inserts fasten to a metal tibial tray by means of a central pin and interlocking clip or a tibial stabilizing post. The fixative surface of the cross-linked polyethylene tibial trays have a salt-blasted surface, a round central stem, and cloverleaf patterned recesses to enhance cement fixation to the proximal tibia surface. The DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and trays are intended to be used with the currently legally marketed DePuy AMK Total Knee System and/or Coordinate Ultra Knee Revision System in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject DePuy AMK and Coordinate cross-linked polyethylene tibial inserts and trays are substantially equivalent to the AMK Total Knee System and Coordinate Ultra Knee Revision System polyethylene tibial inserts and trays that have previously been cleared in that they have the basic same design and the same intended use. Both the subject cross-linked polyethylene tibial inserts and trays and the previously cleared polyethylene tibial inserts and trays are manufactured from UHMWPE meeting the specifications of ASTM F648. The only difference, other than minor design changes, between the subject components and the previously cleared components is that the subject components are manufactured from cross-linked UHMWPE.
000003
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1998 OCT
Ms. Sally Foust Senior Regulatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re : K982585 DePuy AMK® Total Knee System and Coordinate Ultra™ Knee Revision System: Cross-Linked Polyethylene Tibial Inserts and Trays Requlatory Class: II Product Code: JWH Dated: July 23, 1998 Received: July 24, 1998
Dear Ms. Foust:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on these devices being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone You may, therefore, market your devices subject to cement." the general controls provisions of the Act and the following limitations:
- The thinnest tibial insert available is the nominal 1. "10mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.02mm.
- The thinnest tibial tray available is the nominal "10mm" 2. sized tray, which has a minimum polyethylene thickness under the condyles of 10.5mm.
- These devices may not be labeled or promoted for non-3 . cemented use.
- All labeling for these devices, including package label 4 . and labeling included within the package, must
2
Page 2 - Ms. Sally Foust
prominently state that the devices are intended for cemented use only.
- Any non-cemented fixation of these devices is 5. considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investiqation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your devices in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note
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3
Page 3 - Ms. Sally Foust
the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible in the factorers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known)_K982585
DePuy AMK® Total Knee System and Coordinate Ultra™ Knee Device Name: Revision System: Cross-Linked Polyethylene Tibial Inserts and Trays
Indications for Use:
The DePuy AMK and Coordinate Ultra Cross-Linked Polyethylene Inserts and Trays are to be used with the currently marketed AMK Total Knee System and/or the Coordinate Ultra Knee Revision System components.
The DePuy AMK Total Knee System and Coordinate Ultra Knee Revision System are intended to be used in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or posttraumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Concurrence of CDRH, Office of Device Evaluation
× Prescription Use
OR (Per 21 CFR 801.109) Over-The Counter Use
000002