(44 days)
No
The summary describes a mechanical hip prosthesis and makes no mention of AI or ML.
Yes
The device is a prosthesis designed to replace a damaged hip joint, which aligns with the definition of a therapeutic device as it treats a medical condition.
No
The device is a femoral hip prosthesis, used for replacing a damaged hip joint in total hip arthroplasty. Its intended use is therapeutic (replacement) rather than diagnostic (identifying a disease or condition).
No
The device description clearly describes a physical hip prosthesis made of materials and available in different sizes and configurations, indicating it is a hardware 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.
- Device Description: The provided text describes a femoral hip prosthesis, which is an implantable device used to replace a damaged hip joint. This is a surgical device, not a diagnostic test performed on samples.
- Intended Use: The intended use is to replace a damaged hip joint, which is a surgical procedure, not a diagnostic process.
The information provided clearly indicates this is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The DePuy Profile® Femoral Hip with Porocoat® prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of a patient whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.
Product codes
LPH, 87LPH
Device Description
The DePuy Profile® Hip with Porocoat® prosthesis is identical in design and materials to the DePuy Profile® Hip with Porocoat® prosthesis cleared by FDA for cemented use (K872776). The prosthesis is designed with an anatomical conformance to the medullary canal, proximal porous-coating, rounded distal taper, and 12/14 femoral neck taper which allows for the use of interchangeable modular femoral heads. The prosthesis is available in six sizes, each are available in right and left configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K934457, K872776, K910156, K850055
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| SPONSOR OF THIS 510(K): | DePuy Orthopaedics, Inc.
a Johnson & Johnson company
P.O. Box 988
700 Orthopaedics Drive
Warsaw, Indiana 46581-0988 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust
Sr. Regulatory Associate
DePuy Orthopaedics, Inc.
a Johnson & Johnson company
(219) 372-7455; FAX (219) 267-7098 |
| TRADE NAME: | DePuy Profile® Femoral Hip with Porocoat® |
| COMMON NAME: | Hip Device |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrained
porous coated uncemented prosthesis |
| DEVICE CODE: | 87LPH |
| EQUIVALENT DEVICES: | DePuy Stability Hip System with Porocoat®
(K934457) (Uncemented, K934457)
DePuy Profile® Femoral Hip Prosthesis with
Porocoat® (Cemented, K872776)
DePuy Hydroxyapatite Coated Profile® Hip Stem
(Press-Fit, K910156)
DePuy Profile® Femoral Hip (Press-Fit, K850055) |
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Profile® Hip with Porocoat® prosthesis is identical in design and materials to the DePuy Profile® Hip with Porocoat® prosthesis cleared by FDA for cemented use (K872776). The prosthesis is designed with an anatomical conformance to the medullary canal, proximal porous-coating, rounded distal taper, and 12/14 femoral neck taper which allows for the use of interchangeable modular femoral heads. The prosthesis is available in six sizes, each are available in right and left configurations.
The DePuy Profile® Femoral Hip with Porocoat® prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of a patient whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Profile® Hip with Porocoat® prosthesis is similar in design (proximal porous coating, anatomical, and modular heads), identical in material (Ti-6AI-4V alloy) and intended use (uncemented) to the previously cleared DePuy Stability Hip (K934457).
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With the exception of the additional intended use (uncemented), the DePuy Profile® Femoral Hip with Porocoat® prosthesis is identical in design, material (Ti-6AI-4V alloy) and intended use (cemented) to the previously cleared DePuy Profile® Femoral Hip with Porocoat® prosthesis (K872776). The material (Ti-6A1-4V alloy conforming to ASTM F-620), manufacturing process and design of the DePuy Profile® Hip with Porocoat® prosthesis, including stem diameters, location of the porous coating and characteristics of the porous coating will not be changed from those of the DePuy Profile® Hip with Porocoat® prosthesis previously cleared (K872776) by FDA.
The DePuy Profile® Hip with Porocoat® prosthesis is identical in material (Ti-6Al-4V alloy), similar in design (proximal porous coating, anatomical, and modular heads), and similar in intended use (uncemented) to the previously cleared DePuy Profile® Hip with Hydroxyapatite (K910156) and DePuy Profile® Hip (K850055).
Based on the information provided in this premarket notification, DePuy considers the DePuy Profile® Hip with Porocoat® prosthesis to be substantially equivalent to uncemented hip prostheses that are currently legally marketed.
| | Profile®
Porocoat®
(this submission) | Stability
K934457 | Profile®
Porocoat®
K872776 | Profile®
Hydroxyapatite
K910156 | Profile®
K850055 |
|-----------------------------|--------------------------------------------|-----------------------------|----------------------------------|---------------------------------------|-----------------------|
| Intended Use | Uncemented | Uncemented | Cemented | Press-Fit | Press-Fit |
| Stem Material | Ti-6Al-4V
ASTM-620 | Ti-6Al-4V
ASTM-620 | Ti-6Al-4V
ASTM-620 | Ti-6Al-4V
ASTM-620 | Ti-6Al-4V
ASTM-620 |
| Proximal
Surface Coating | Porocoat®
Porous-coating | Porocoat®
Porous-coating | Porocoat®
Porous-coating | Hydroxyapatite | None |
| Design | Anatomical | Anatomical | Anatomical | Anatomical | Anatomical |
| Modular Heads | Yes | Yes | Yes | Yes | Yes |
| Modular Taper | 12/14mm | 12/14mm | 12/14mm | 12/14mm | 12/14mm |
The following table summarizes the similarities:
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Ms. Sally Foust Senior Regulatory Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K984459 DePuy Profile® Femoral Hip with Porocoat® Trade Name: Requlatory Class: II Product Code: LPH December 14, 1998 Dated: December 15, 1998 Received:
Dear Ms. Foust:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, 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. ત substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (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 regulation 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.
3
Page 2 - Ms. Sally Foust
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, 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 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.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
510(k) Number (if known)_K984459
Device Name: DePuy Profile Femoral Hip with Porocoat: Additional Indication
Indications for Use:
The DePuy Profile Femoral Hip with Porocoat prosthesis is indicated for uncemented or cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of a patient whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.
Concurrence of CDRH, Office of Device Evaluation
OR
Prescription Use_ X (Per 21 CFR 801.109) Over-The-Counter Use_
beall
(Divisior Division of General Restorative I 510(k) Number