(30 days)
Not Found
No
The summary describes a mechanical implant (hip stem) and its material properties and intended use. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as aiding the surgeon in "relieving the patient of hip pain and restoring hip motion," which aligns with the definition of a therapeutic device designed to treat a medical condition and improve patient health.
No
The device description indicates it is a "UNI Hip Stem" used in total hip arthroplasty to replace the natural femoral head. Its purpose is to relieve pain and restore hip motion, not to diagnose a condition.
No
The device description clearly describes a physical implantable hip stem made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating patients undergoing total hip arthroplasty due to disease or trauma, or for failed hip arthroplasties. It's a surgical implant used in the body.
- Device Description: The description details a physical implant (a hip stem) made of titanium alloy, designed to be surgically inserted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of these specimens.
This device is a surgical implant used directly in the patient's body during a surgical procedure.
N/A
Intended Use / Indications for Use
The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Product codes
LWJ, JDI
Device Description
This stem has a flat rectangular cross sectional geometry that is intended to withstand rotational stress. The large proximal surfaces transmits stress to the greater trochanter and the arch of the calcar. This geometry achieves high primary stability and lays the foundation for good secondary stability.
This cementless stem is manufactured from titanium alloy (Ti6Al4V per ASTM F136) and the body surface is blasted with corrundum media. It is available in twelve stem sizes and has a 12/14 neck taper to accept 22, 28 or 32mm metal or ceramic heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (femoral head)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
Fatigue testing per ISO 7206-4 was successfully performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
K 014/34 pg19/
510(k) Summary
Date December 13, 2002
Submitter
PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121-2700
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-4694
Common name
Press-fit hip stem
Classification name
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented (per 21 CFR section )
Equivalent Device
SL-PLUS Stem cleared on K001942.
Device Description
This stem has a flat rectangular cross sectional geometry that is intended to withstand rotational stress. The large proximal surfaces transmits stress to the greater trochanter and the arch of the calcar. This geometry achieves high primary stability and lays the foundation for good secondary stability.
This cementless stem is manufactured from titanium alloy (Ti6Al4V per ASTM F136) and the body surface is blasted with corrundum media. It is available in twelve stem sizes and has a 12/14 neck taper to accept 22, 28 or 32mm metal or ceramic heads.
Intended Use
The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Summary of Technological Characteristics Compared to Predicate Device
The UNI Stem is similar to the SL-PLUS Stem. Both stems have the same overall stem profile and are manufactured from similar titanium alloys (Ti6Al4V - UNI Stem & Ti6Al7Nb - SL-PLUS Stem). The indications for use are the same for both stems. The only difference are the minor change in material, removal of lateral suture holes from the SL-PLUS stem, and slightly smaller cross section and head offset for the Uni stem.
Summary Nonclinical Tests
Fatigue testing per ISO 7206-4 was successfully performed.
JAN 1 5 2003
1
Image /page/1/Picture/1 description: The image is a black and white 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 a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2003
PLUS Orthopedics C/o Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, TX 78681
Re: K024134 Trade/Device Name: UNI Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: LWJ, JDI Dated: December 13, 2002 Received: December 16, 2002
Dear Mr. Webb:
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. 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 (PMA), 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. J. D. Webb
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) number (if known):_____________________________________________________________________________________________________________________________________________________
K 024134
Device Name: UNI Hip Stem
Indications for Use:
UNI Hip Stem Indications for Use
The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Mark N Milkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices 024134 510(k) Number_