(190 days)
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No
The document describes a physical medical device (a knee implant component) and contains no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is intended to replace severely disabled or painful joints, which is a therapeutic function.
No
The device, the DePuy AMK 3 Peg Patella, is an all polyethylene patella component intended for use with a total knee system to replace severely disabled or painful joints. It is a surgical implant, not a tool for diagnosing medical conditions.
No
The device description clearly states it is an "all polyethylene patella component," indicating it is a physical implant, not software.
Based on the provided information, the DePuy AMK 3 Peg Patella is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for surgical implantation in the knee to replace a damaged joint. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a physical implantable component made of polyethylene.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DePuy AMK 3 Peg Patella is a prosthetic implant used for treatment.
N/A
Intended Use / Indications for Use
The DePuy AMK 3 Peg Patella is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The DePuy AMK 3 Peg Patella is an all polyethylene patella component with a domed articular surface and a 3 peg fixation surface. It is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing indicates that the fixation strength of the AMK 3 Peg Patella is similar to those of the Johnson & Johnson PFC Oval Sombrero Patella and the Zimmer NexGen All Polyethylene Patella.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
DePuy AMK All Polyethylene Patella, DePuy LCS 3 Peg Patella, Johnson & Johnson PFC Oval Sombrero Patella
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.
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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).
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§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc. |
|---|---|
| 700 Orthopaedic Drive | |
| Warsaw, Indiana 46581-0988 | |
| 510(k) CONTACT: | Cheryl Hastings |
| Manager, Clinical Affairs | |
| TRADE NAME: | DePuy AMK 3 Peg Patella |
| COMMON NAME: | All Polyethylene Patella |
| CLASSIFICATION: | 888.3560 Prosthesis, Knee, PatelloFemorotibial, Semiconstrained, Cemented, Polymer, Metal, Polymer |
| DEVICE PRODUCT CODE: | 87 JWH |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy AMK All Polyethylene PatellaDePuy LCS 3 Peg PatellaJohnson & Johnson PFC Oval Sombrero Patella |
- Zimmer NexGen All Polyethylene Patella જુન
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy AMK 3 Peg Patella is an all polyethylene patella component with a domed articular surface and a 3 peg fixation surface. It is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, ioints with correctable varus or valgus deformity and joints with failed previous surgeries where pain, deformity or dysfunction persist.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy AMK 3 Peg Patella is identical to the AMK All Polyethylene Patella which has been previously cleared by FDA except that the fixation surface has been changed from two circular arcs to 3 pegs. The material, intended use and design of the articular surface of the patella are the same as those of the original AMK All Polyethylene Patella. The 3 peg fixation surface is similar to the fixation surface used on the DePuy LCS All Polyethylene 3 Peg Patella. Testing indicates that the fixation strength of the AMK 3 Peg Patella is similar to those of the Johnson & Johnson PFC Oval Sombrero Patella and the Zimmer NexGen All Polyethylene Patella.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1998
Ms. Cheryl Hastings Manager, Regulatory Submissions DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K972643 Re : AMK 3 Peq Patella Requlatory Class: II Product Code: JWH Dated: December 17, 1997 Received: December 19, 1997
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone You may, therefore, market your device subject to cement . " the general controls provisions of the Act and the following limitations:
- This device may not be labeled or promoted for non-1. cemented use.
-
- All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
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Page 2 - Ms. Cheryl Hastings
- Any non-cemented fixation of this device is considered 3. 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 investigation.
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 device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: 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 Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device 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 device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
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Page 3 - Ms. Cheryl Hastings
obtained from the Division of Small Manufacturers 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
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510(k) Number (if known) _k972643
Device Name AMK 3 Peg Patella
Indications for Use:
The DePuy AMK 3 Peg Patella is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended 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.
Concurrence of CDRH, Office of Device Evaluation
Acolla
(Div Divisi of General Restorative Devices 510(k) Number. K97264
Prescription Use >>
OR
Over-The Counter Use
(Per 21 CFR 801.109)