(24 days)
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Not Found
No
The summary describes a mechanical hip implant and its intended use, with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is a hip stem system used in total hip arthroplasty to restore the femoral side of a total joint and address various arthritic conditions or failed procedures, which are considered therapeutic interventions.
No
Explanation: The device is described as a hip stem system for total hip arthroplasty, which is a surgical implant designed to treat joint diseases or injuries. It is not used to diagnose a medical condition.
No
The intended use and anatomical site descriptions clearly indicate this device is a physical hip stem system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (a hip stem) used in a total hip arthroplasty procedure. This is a medical device used in vivo (within the body) for structural support and joint replacement.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The B2C hip stem system does not perform any such testing.
- Anatomical Site: The anatomical sites mentioned (femoral hip, femoral cavity, femoral head, acetabular) are all parts of the human musculoskeletal system where a surgical implant would be placed.
- Lack of IVD Characteristics: The description lacks any mention of laboratory testing, samples, analysis of biological materials, or diagnostic information derived from such analysis.
Therefore, the B2C hip stem system is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The B2C hip stem system is intended to be used as a press fit or cemented femoral hip component as part of a total hip arthoplasty. The stem geometry has been designed to be either implanted with or without cemented into the femoral cavity.
The stems are to be used to restore the femoral side of a total joint arthoplasty and is used in conjunction with an acetabular cup. The indications for use of the B2C hip system are as follows: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies. Salvage of previous unsuccessful procedures such as osteosynthesis, joint reconstruction, arthrodesis, hemi or total hip arthroplasty. Bipolar head or Austin Moore type head revision. Fracture or avascular necrosis of the femoral head in the elderly. Replacement of acetabular and stem component in total hip arthroplasty. Primary arthroplasty of the acetabular in dysplastic hips.
Product codes
JDI
Device Description
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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
femoral, hip
Indicated Patient Age Range
elderly
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)
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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.
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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
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird in flight, with three horizontal lines forming the body and wings, and a wavy line representing the tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 1999
Mr. Douglas W. Stuart Lepine Group Spa. C/O Surgical Implants Incorporated 962 South Tamiami Trail, Suite 203 Sarasota, Florida 34326
Re: K992490 Trade Name: Lepine, B2C Hip System Regulatory Class: II Product Code: JDI Dated: July 21, 1999 Received: July 26, 1999
Dear Mr. Stuart:
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 control provisions of the Act. The general control provisions 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. 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.
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Page 2 - Mr. Douglas W. Stuart
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,
Russell Sage
Ser 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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page 6
EXHIBIT 9
K 992490 510(K) Number not known Device Name: B2C Hip Stem System
Statement of Intended Use
Indications For Use:
The B2C hip stem system is intended to be used as a press fit or cemented femoral hip component as part of a total hip arthoplasty. The stem geometry has been designed to be either implanted with or without cemented into the femoral cavity.
The stems are to be used to restore the femoral side of a total joint arthoplasty and is used in conjunction with an acetabular cup. The indications for use of the B2C hip system are as follows: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies. Salvage of previous unsuccessful procedures such as osteosynthesis, joint reconstruction, arthrodesis, hemi or total hip arthroplasty. Bipolar head or Austin Moore type head revision. Fracture or avascular necrosis of the femoral head in the elderly. Replacement of acetabular and stem component in total hip arthroplasty. Primary arthroplasty of the acetabular in dysplastic hips.
Signed:
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Russell Ligone Sor Jr
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992490
Prescription Use X
(Per 21 CFR 801.109)
.
OR
Over The Counter Use _
(Optional Format 1-2-96)