(49 days)
Not Found
No
The device description focuses on the materials and physical characteristics of an acetabular shell, insert, and screw plug, which are components of a hip replacement system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
This device is a therapeutic device because its intended use is to treat various medical conditions affecting the hip, such as osteoarthritis, rheumatoid arthritis, avascular necrosis, and traumatic arthritis, by replacing or supplementing joint components.
No
The device description indicates that the Providence acetabular shell, insert, and screw plug are components of a hip replacement system, designed to replace parts of the hip joint. Its intended use is to treat various conditions like osteoarthritis and avascular necrosis by being implanted in the body, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components made of titanium and UHMWPE, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed (Osteoarthritis, Rheumatoid arthritis, Avascular necrosis, Traumatic arthritis) are all conditions affecting the hip joint. The device is described as being used in conjunction with a femoral stem and head, indicating it's a component of a hip replacement system.
- Device Description: The description details the materials and design of an acetabular shell, insert, and screw plug – components of a hip implant.
- Anatomical Site: The anatomical site is the hip.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The device is a physical implant used to replace a damaged joint.
In vitro diagnostics are tests performed on samples taken from the body, outside of the body itself. This device is an implantable medical device used for surgical treatment.
N/A
Intended Use / Indications for Use
Indications for Use:
- A) Osteoarthritis
- B) Rheumatoid arthritis with severe hip pain and limited joint motion
- C) Avascular necrosis
- D) Traumatic arthritis
E) To be used in conjunction with a Biopro femoral stem and a 28mm or 32mm Biopro ceramic or cobalt chrome head.
Product codes (comma separated list FDA assigned to the subject device)
JDI and LZO
Device Description
Proprietary name: Providence Cup System
Common name: Prosthesis, Hip, Semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented
Classification name: Prosthesis, Hip. Semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented
Acetabular Cup
The Providence acetabular shell is manufactured from 6-4 Eli Titanium. It is porous coated and contains screw holes to allow for additional fixation. The acetabular component houses 28mm and 32mm ID inserts that are either neutral or lipped. It is available in eight sizes: 46mm, 48mm, 50mm, 52mm, 56mm, 56mm, 58mm, and 60mm.
Acetabular Insert
The Providence acetabular insert is manufactured from UHMWPE. It is designed to snap-fit into the acetabular cup. The acetabular cup will accept 28mm and 32mm heads. It is available in both a neutral and hooded variety. The insert is available in sizes ranging from 46mm to 60mm.
Screw Plug
The Providence screw plug is manufactured from 6-4 Eli Titanium. It is used to plug the threaded impaction hole in the acetabular shell.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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): 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.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
4/29/99
510 (k) Summary
Submitted By: Biopro
17 17th Street Port Huron, MI 48060 Contact: Cheryl Warsinske (810) 982-7777 Fax (810) 982-7794
Device Information:
Proprietary name: Providence Cup System
Common name: Prosthesis, Hip, Semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented
Classification name: Prosthesis, Hip. Semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented
Acetabular Cup
The Providence acetabular shell is manufactured from 6-4 Eli Titanium. It is porous coated and contains screw holes to allow for additional fixation. The acetabular component houses 28mm and 32mm ID inserts that are either neutral or lipped. It is available in eight sizes: 46mm, 48mm, 50mm, 52mm, 56mm, 56mm, 58mm, and 60mm.
Acetabular Insert
The Providence acetabular insert is manufactured from UHMWPE. It is designed to snap-fit into the acetabular cup. The acetabular cup will accept 28mm and 32mm heads. It is available in both a neutral and hooded variety. The insert is available in sizes ranging from 46mm to 60mm.
Screw Plug
The Providence screw plug is manufactured from 6-4 Eli Titanium. It is used to plug the threaded impaction hole in the acetabular shell.
Substantial Equivalence:
The Providence Cup System is substantially equivalent to the Horizon Cup System (510k # K962769). Both cups are low profile cups and both house the same acetabular insett. The OD of both cups is porous coated. The Providence shell is also equivalent to the Interseal shell from Wright Medical Technology. The outer geometry of the two cups is very similar.
The Horizon cup is manufactured from cobalt chrome and the Providence cup is manufactured from titanium. The Interseal cup is cobalt chrome.
The Horizon cup contains three external pegs, which aid in fixation, while the Providence cup contains screw holes to accept screws for fixation. The Providence cup contains a through impaction hole to accept an impaction tool. The Horizon cup contains a blind impaction hole. A screwplug is provided to plug the immaction hole in the Providence cup. The Interseal cup also contains an impaction hole in the dome and can be used with a screwplug.
Although there are minor differences between the Horizon cup and the Providence cup, they are substantially equivalent in form and function. All three systems are indicated for treatment of osteoarthritis, theumatoid arthritis, avascular necrosis, and traumatic arthritis. Contraindications include: excessive bone loss, septic arthritis, periarticular osteomyelitis, and local or systemic infection.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Cheryl L. Warsinske, M.S. Director of Enqineering Biopro, Inc. 17 Seventeenth Street Port Huron, Michigan 48060
Re: K990821 Providence Cup System Trade Name: Requlatory Class: II Product Codes: JDI and LZO Dated: March 5, 1999 March 11, 1999 Received:
Dear Ms. Warsinske:
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). 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 Requlations, 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 action. In addition, FDA may publish further announcements 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.
2
Page 2 - Cheryl L. Warsinske, M.S.
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 requlation (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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
K99,0821
510k Number (if known):
Device Name: The Providence Cup System
Indications for Use:
- A) Osteoarthritis
- B) Rheumatoid arthritis with severe hip pain and limited joint motion
- C) Avascular necrosis
- D) Traumatic arthritis
E) To be used in conjunction with a Biopro femoral stem and a 28mm or 32mm Biopro ceramic or cobalt chrome head.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
e Evaluation (ODE)
(Division/Sign-Off)
Division of General Restorative Devices
510(k) Number K 990
Prescription Use ---(Per 21 CFR 801.109)
OR
Over The Counter Use ---(Optional Format 1-2-96)