(115 days)
Not Found
No
The device description and intended use focus solely on the mechanical design and materials of the femoral stems for hip replacement. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a femoral stem used in hip replacement procedures to alleviate severe pain and disability caused by conditions impacting the hip joint. Its purpose is to correct structural damage and restore hip function, which aligns with the definition of a therapeutic device.
No
The device description indicates that the G2 Total Hip System Femoral Stems are implants used in hip replacement procedures, designed to replace damaged hip joints. This is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components made of titanium alloy and cobalt chromium, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a femoral stem, which is a component of a hip replacement prosthesis. This is an implantable device used in surgery to replace a damaged part of the hip joint.
- Intended Use: The intended use clearly states that the device is for use in total or partial hip replacement procedures for patients with various hip conditions. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The description of the device, its intended use, and the performance studies all point to it being a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The G2 Total Hip System Femoral Stems (11/13 Taper) are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatiod arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenial hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The G2 Polished Femoral Stem (11/13 taper) is indicated for use only with PMMA bone cement.
The G2 Microtextured Femoral Stem (11/13 taper) is not indicated for use with PMMA bone cement.
Product codes
LZO, JDI, KWY
Device Description
G2 Cementless Femoral Stem
The cementless G2 femoral stems are made of the titanium alloy which is microtextured/roughened and available in 12 sizes with both a standard neck length and an offset neck length. These stems are designed with a series of anterior and posterior fins on the proximal portion of the press fit stem and a proximal to distal taper. The design features of the press fit stem allow for axial load transfer to the bone while minimizing shear loads at the stem and bone interface. The design also features initial torsional stability, enhancement of load transfer and the minimizing of micromotion.
G2 Cemented Femoral Stem
The cemented G2 stems are forged cobalt chromium with a polished surface and are available in 6 sizes, with both standard and offset neck lengths. They have a double taper collarless geometry with a proximal lateral flange, as well as mid shaft PMMA cement spacers to allow for centralization of the stem in the cement. The design features of the polished stem allow for proper seating of stem in cement, reduction of torsional stesses in the proximal section of the cement mantle, and potentially minimize cement debris at the stem interface during micromotion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, hip, femoral
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)
The G2 Total Hip System Femoral Stems (11/13 taper) were evaluated following the ISO standard titled 7206-4- Implants for Surgery - Partial and Total Joint Prosthesis -Part 4 which ensures conformance to the FDA's Draft Guidance Document for Femoral Stem Prothesis. Test results for both the titanium and cobalt chrome femoral stems were provided in this submission and demonstrated conformity to the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K964769, K963109, K933570, K944592, K945518, K963885, K972435, K924379
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
4 1998 DEC
Summary of Safety and Effectiveness Data for the G2 Total Hip System Femoral Stem (11/13 Taper)
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
Mary E. Gray Associate Regulatory Affairs Specialist Phone: (508) 828-3545 (508) 828-3212 Fax:
Name of Device
G2 Total Hip System Femoral Stem (11/13 Taper)
Device Classification
This device has been placed in Class II for Hip joint femoral (hemi-hip) metal /polymer cemented or uncemented prosthesis per 21 CFR § 888.3390.
Physical Description
G2 Cementless Femoral Stem
The cementless G2 femoral stems are made of the titanium alloy which is microtextured/roughened and available in 12 sizes with both a standard neck length and an offset neck length. These stems are designed with a series of anterior and posterior fins on the proximal portion of the press fit stem and a proximal to distal taper. The design features of the press fit stem allow for axial load transfer to the bone while minimizing shear loads at the stem and bone interface. The design also features initial torsional stability, enhancement of load transfer and the minimizing of micromotion.
G2 Cemented Femoral Stem
The cemented G2 stems are forged cobalt chromium with a polished surface and are available in 6 sizes, with both standard and offset neck lengths. They have a double taper collarless geometry with a proximal lateral flange, as well as mid shaft PMMA cement spacers to allow for centralization of the stem in the cement. The design features of the polished stem allow for proper seating of stem in cement, reduction of torsional stesses in the proximal section of the cement mantle, and potentially minimize cement debris at the stem interface during micromotion.
1
Indications for Use
The G2 Total Hip System Femoral Stems (11/13 Taper) are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to
structural damage in the hip joint from rheumatiod arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenial hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The G2 Polished Femoral Stem (11/13 taper) is indicated for use only with PMMA bone cement.
The G2 Microtextured Femoral Stem (11/13 taper) is not indicated for use with PMMA bone cement.
Summary of Testing_
The G2 Total Hip System Femoral Stems (11/13 taper) were evaluated following the ISO standard titled 7206-4- Implants for Surgery - Partial and Total Joint Prosthesis -Part 4 which ensures conformance to the FDA's Draft Guidance Document for Femoral Stem Prothesis. Test results for both the titanium and cobalt chrome femoral stems were provided in this submission and demonstrated conformity to the standard.
Statement of Substantial Equivalence
The G2 Total Hip System Femoral Stems are substantially equivalent in material and function to the following list of commercially distributed products:
| Zimmer Versys™ Enhanced Taper
| Hip System | K964769 |
|---|---|
| Zimmer Heritage™ Hip System | K963109 |
| Wright Resolution™ Microtextured | |
| Femoral Component | K933570 |
| Howmedica Precision Osteolock™ | |
| Hip System | K944592 |
| Johnson & Johnson Professional, Inc. | |
| P.F.C. ® 2 Hip System | K945518 |
| Johnson & Johnson Professional, Inc. | |
| ULTIMA® Fx Femoral Hip System | K963885 |
| Johnson & Johnson Professional, Inc. | |
| ULTIMA® LX Femoral Hip System | K972435 |
| K924379 |
2
Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 4 1998
Ms. Marv E. Gray Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767 Raynham, Massachusetts
Re: K982812 G2 Total Hip System Femoral Trade Name: Stems (11/13 Taper) Requlatory Class: II Product Codes: LZO, JDI, and KWY Dated: September 30, 1998 October 1, 1998 Received:
Dear Ms. Gray:
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 of the Act. 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.
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlation 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.
3
Page 2 - Ms. Mary E. Gray
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 Radiological Health
Enclosure
4
510(k) Number (if known) Device Name
G2 Total Hip System Femoral Stem (11/13 Taper)
Indications For Use
The G2 Total Hip System Femoral Stems (11/13 Taper) are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatiod arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenial hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The G2 Polished Femoral Stem (11/13 taper) is indicated for use only with PMMA bone cement.
The G2 Microtextured Femoral Stem (11/13 taper) is not indicated for use with PMMA bone cement.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)