(28 days)
Not Found
No
The document describes a hip stem implant and its intended use, focusing on mechanical properties and biocompatibility testing. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The Provident II Hip Stems are intended to treat various joint conditions, including degenerative joint disease, rheumatoid arthritis, and fractures, which indicates a therapeutic purpose.
No
The device description clearly states its purpose is to expand an existing hip system with new stems, indicating it is an implant for treatment rather than diagnosis. The "Intended Use / Indications for Use" list conditions that the device treats (e.g., degenerative joint disease, fractures, rheumatoid arthritis), further confirming its therapeutic nature.
No
The device description clearly states it is a "Provident II Hip Stems" which are physical implants, not software. The 510(k) is for a line extension of existing hip stems.
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 clearly describe the treatment of various conditions affecting the hip joint through surgical implantation. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a hip stem, a component of a total hip arthroplasty. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
-
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis , and avascular necrosis.
-
- Rheumatoid Arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
- Revision of previously failed total hip arthroplasty.
Product codes
LPH, JDI, LWJ, LZO, OOH, OOI, KWY
Device Description
The purpose of this Special 510(k) is to expand the Provident Hip System with a line extension to the existing Provident Hip Stems. The new stems are to be marketed as the Provident II Hip Stems and feature a shortened stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
An engineering analysis was performed on both the modified and predicate stems. All results demonstrate that the modified device performs similarly to the predicate device. Limulus Amebocyte Lysate (LAL) testing has been performed to establish that the device meets pyrogen limit specifications.
Key Metrics
Not Found
Predicate Device(s)
K935484, K946371, K001745, K002796, K094035, K122773
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
March 8, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services - USA. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
StelKast, Inc. % Hollace Rhodes Senior Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20005
Re: K190276
Trade/Device Name: Provident II Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI, LWJ, LZO, OOH, OOI, KWY Dated: February 7, 2019 Received: February 8, 2019
Dear Hollace Rhodes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Daniel S. Ramsey -S 2019.03.08 16:29:51 -05'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Provident II Hip Stem
Indications for Use (Describe)
-
- Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis , and avascular necrosis.
-
- Rheumatoid Arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
7 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
| Manufacturer: | StelKast, Inc. |
|---|---|
| 200 Hidden Valley Road | |
| McMurray, PA 15317 | |
| Phone: 724.731.2208 | |
| Contact: | Mr. David Stumpo |
| Vice President of Operations | |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: 202.552.5800 | |
| Date Prepared: | March 5, 2019 |
| Device Trade Name: | Provident II Hip Stems |
| Device Common Name: | Hip Prosthesis |
| Classification: | 21 CFR 888.3358: Hip joint metal/polymer/metal semi- |
| constrained porous-coated uncemented prosthesis – Class II | |
| 21 CFR 888.3350: Hip joint metal/polymer semi-constrained | |
| cemented prosthesis – Class II | |
| 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi- | |
| constrained cemented or nonporous uncemented prosthesis – Class II | |
| 21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented | |
| or uncemented prosthesis – Class II | |
| 21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer | |
| cemented or uncemented prosthesis – Class II |
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| Indications for Use: | 1. Non-inflammatory degenerative joint disease including
osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid Arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric
fractures of the proximal femur with head involvement,
unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The purpose of this Special 510(k) is to expand the Provident Hip
System with a line extension to the existing Provident Hip Stems.
The new stems are to be marketed as the Provident II Hip Stems and
feature a shortened stem. |
| Predicate Devices: | The Provident II Hip Stems are substantially equivalent to the
predicate stems of the Provident Hip Stem line (K935484,
K946371, K001745, K002796, K094035, K122773), with respect
to intended use, materials, design, range of available sizes, method
of fixation, and performance characteristics. The information
summarized in the Design Control Activities Summary
demonstrates that the modified stem length of the Provident II Hip
Stem meets the pre-determined acceptance criteria for the
verification activities. |
| Substantial
Equivalence: | An engineering analysis was performed on both the modified and
predicate stems. All results demonstrate that the modified device
performs similarly to the predicate device.
Limulus Amebocyte Lysate (LAL) testing has been performed to
establish that the device meets pyrogen limit specifications. |