(78 days)
K# 962248, K# 933275, K# 921111
Not Found
No
The 510(k) summary describes a ceramic femoral head for hip replacement, a purely mechanical device. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a femoral head intended for use in total hip replacement procedures to alleviate severe pain and disability caused by conditions affecting the hip joint. This directly addresses and treats a medical condition, classifying it as a therapeutic device.
No
Explanation: The device is a ceramic femoral head, which is an implant used in total hip replacement procedures. Its purpose is to replace a damaged part of the hip joint, not to diagnose a condition.
No
The device description clearly states it is a physical ceramic femoral head, which is a hardware component, not software.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a Surgical Implant (a femoral head for hip replacement). Its intended use is to be surgically implanted into the hip joint to replace damaged bone and restore function. It does not involve the examination of specimens taken from the body.
Therefore, based on the provided information, the S-ROM Zirconia Ceramic Femoral Head is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The S-ROM Zirconia Ceramic Hip Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.
Product codes
87 LZO, TLLO
Device Description
The S-ROM Zirconia Ceramic hip head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®. The S-ROM ceramic hip heads are designed to be used with the S-ROM Total Hip System femoral stems.
The ceramic femoral heads are contraindicated for use with any acetabular components other than an UHMWPE cup or metal backed UHMWPE cup.
The S-ROM Zirconia Ceramic Femoral Hip Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the 11/13 Morse taper trunnions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
K# 962248, K# 933275, K# 921111
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
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arti nesser in
NOV 2 0 1997
Summary of Safety and Effectiveness Data for the S-ROM® Zirconia Ceramic Femoral Head
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person_
Mary E. Gray Associate Regulatory Affairs Specialist Phone: (508) 828-3545 Fax: (508) 828-3212
Name of Device
Proprietary Name: | S-ROM Zirconia Ceramic Femoral Head |
---|---|
Common Name: | Hip Prosthesis |
Classification Name: | Hip joint metal/ceramic/polymer semi-constrained |
cemented or nonporous uncemented prosthesis. | |
Regulatory Class: | Class II by 21 CFR 888.3353 |
Product Code: | 87 LZO |
Owner/Operator No.: | 9001269 |
Device Classification_
This device has been placed in Class II for Hip joint metal/ ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR § 888.3353.
Statement of Substantial Equivalence_
The S-ROM Zirconia Ceramic Hip Head is identical in material (PROZYR®) and in function (indicated use) to the P.F.C. Zirconia Ceramic Hip Head cleared for marketing under premarket notifications K# 962248 (August 29, 1996)/ K# 933275 (September 28, 1994).
The S-ROM Zirconia Ceramic Hip Head is identical in design (drawing specifications) and function (indicated use) to the S-ROM Zirconia Ceramic Hip Head cleared for marketing under premarket notification K# 921111.
The subject device is composed of similar materials to the predicate device mentioned above (P.F.C. Zirconia Ceramic Hip Head). Further, the intended use and the manufacture of the S-ROM Ziconia Ceramic Hip Head are substantially equivalent to those already cleared for domestic commercial distribution.
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Additionally, the packaging and method of sterilization utilized for the S-ROM Zirconia Ceramic Hip Head are the same as those used for the previously mentioned predicate device.
Indications for Use
The S-ROM Zirconia Ceramic Hip Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.
Physical Description_
The S-ROM Zirconia Ceramic hip head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®. The S-ROM ceramic hip heads are designed to be used with the S-ROM Total Hip System femoral stems.
The ceramic femoral heads are contraindicated for use with any acetabular components other than an UHMWPE cup or metal backed UHMWPE cup.
S-ROM® Zirconia Ceramic Femoral Heads
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle is facing right, and the profiles are arranged in a way that they form the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Ms. Mary E. Gray Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts
Re: K973307 S-ROM® Zirconia Ceramic Femoral Hip Head for Use with the S-ROM® Total Hip System Regulatory Class: II Product Code: Code: TLLO Trip Dated: September 2, 1997 Received: September 3, 1997
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 and the following limitation that the package insert must reflect that the S-ROM Zirconia Ceramic Femoral Hip Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the 11/13 Morse taper trunnions.
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. 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to
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Page 2 - Ms. Mary E. Gray
comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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,
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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Indications for Use for the S-ROM® Zirconia Ceramic Femoral Head
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Indications of Use
The S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.
Prescription Use
(Per 21 CFR 801.109)
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(Division Sign-Off) (Division of General Restorative Devices 1697370 $10(k) Number .
S-ROM® Zirconia Ceramic Femoral Heads