(384 days)
Not Found
No
The summary describes a mechanical implant and its intended uses, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is a femoral prosthesis intended to replace a hip joint, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. These are therapeutic indications as they aim to treat or alleviate a disease or injury.
No
Explanation: The device is a femoral prosthesis intended to replace a hip joint, which is a treatment not a diagnostic function.
No
The device description explicitly states it is a femoral prosthesis composed of titanium alloy, indicating it is a physical implant, not software.
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 are all related to the surgical replacement of a hip joint due to various conditions affecting the bone and joint structure. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a "femoral prosthesis intended to replace a hip joint." This is a medical device designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for surgical implantation in vivo.
N/A
Intended Use / Indications for Use
-
- Non-inflammatory degenerative joint disease including osteoarthritis, 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, LWJ, LZO, OQH, OQI, KWY
Device Description
The Provident II Hip Stem is a femoral prosthesis intended to replace a hip joint. The subject stem is a line extension of the Provident II Hip System and is fully compatible with existing femoral heads and liners. The stem is composed of titanium alloy, and is coated with commercially pure titanium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical testing (Stem Fatigue, Neck Fatigue) was conducted in accordance with ISO 7206-4:2010, ISO 7206-6:2013, and the "Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses," September 17, 2007, to demonstrate substantial equivalence of the subject stem to the predicate devices.
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
§ 888.3358 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
July 14, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name in a sans-serif font. The full name is "U.S. Food & Drug Administration".
Globus Medical Inc. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K201733
Trade/Device Name: Provident II Hip Stems 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, OQH, OQI, KWY Dated: July 13, 2021 Received: July 14, 2021
Dear Jennifer Antonacci:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known)
Device Name Provident II Hip Stem
Indications for Use (Describe)
-
- Non-inflammatory degenerative joint disease including osteoarthritis, 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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: Provident II Hip Stem
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
| ---------- | ----------------------------------------------------------------------------------------- |
|---|
Contact: Jennifer Antonacci, Ph.D. Group Manager, Regulatory Affairs
- June 24, 2020 Date Prepared:
- Device Name: Provident II Hip Stems
- Hip Prosthesis Common Name:
Classification: Per 21 CFR as follows: §888.3350 Hip joint metal/polymer semi-constrained cemented or nonporous uncemented prosthesis §888.3353 Hip joint metal/ceramic/polymer semi-
- constrained cemented or nonporous uncemented prosthesis
- §888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
- §888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
- §888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Product Codes: LPH, JDI, LWJ, LZO, OQH, OQI, KWY
Regulatory Class: II, Panel Code: 87
Primary Predicate: Provident II Hip Stem (K190276)
Additional Predicate: Provident Hip System (K935484)
Purpose:
The purpose of this submission is to request clearance for additional Provident II Hip Stem implants.
Device Description:
The Provident II Hip Stem is a femoral prosthesis intended to replace a hip joint. The subject stem is a line extension of the Provident II Hip System and is fully compatible with existing femoral heads and liners. The stem is composed of titanium alloy, and is coated with commercially pure titanium.
4
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.
Technoloqical Characteristics:
The subject Provident II Hip Stem has the same technological characteristics as the predicate devices including design, intended use, material composition, and function.
Performance Testing:
Mechanical testing (Stem Fatigue, Neck Fatigue) was conducted in accordance with ISO 7206-4:2010, ISO 7206-6:2013, and the "Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Prostheses," September 17, 2007, to demonstrate substantial equivalence of the subject stem to the predicate devices.
Basis of Substantial Equivalence:
The subject Provident II Hip Stem is similar to the predicate devices with respect to technological characteristics, performance, design, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.