(53 days)
Not Found
No
The device description focuses solely on the material, design, and mechanical properties of a cemented hip stem, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes.
The device is a hip stem intended for total hip arthroplasty to relieve hip pain and restore hip motion in patients with diseased or traumatized femoral heads, which are therapeutic functions.
No
The device description indicates it is a physical implant (cemented hip stem) intended to treat hip pain and restore motion, not to diagnose a condition.
No
The device description clearly details a physical, cemented hip stem made of metal alloy with specific geometric features and components, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat patients requiring total hip arthroplasty due to disease or trauma, or failed previous hip arthroplasties. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (a hip stem) made of metal, designed to be surgically placed within the patient's body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
This device is clearly a surgical implant used in a therapeutic procedure.
N/A
Intended Use / Indications for Use
The PLUS Orthopedics Cemented Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural fead 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
JDI
Device Description
This is a cemented hip stem fabricated from forged cobalt-chromium-molybdenum alloy (CoCrMo) that conforms to ASTM F799. It has a trapezoidal proximal body cross section, tapering both lateral to medial and proximal to distal. The proximal body has a cobra flange along the lateral aspect that helps to apply compressive stresses to the cement. It has a "standard 12/14" Morse type taper to accept modular heads and a neck/shaft angle of 129°. It also has a calcar collar that extends medially only.
The distal stem is conical in shape, tapering proximal to distal end the stem quickly necks down to accept a PMMA distal centralizer is four flanged and is utilized to assure that the distal stem is centered in the femoral canal and a uniform cement mantle is obtained. The distal stem bas four flutes or grooves that increases torsion stability when implanted in cement.
Shallow holes are drilled into the proximal body into which 3m PMMA spacers are pressed. These spacers assure a 3mm cement mantle around the medial, anterior and posterior surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis indicates that this stem will withstand cyclic loads similar to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K922561, K991227, K990369, K013352
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JUN - 6 2003 510(k) Summary
Date April 10, 2003
Submitter
PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock. TX 78681 212-388-0199
Common name
Cemented Hip Stem
Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (per 21 CFR section 888.3350)
Equivalent Device
This cemented hip stem is equivalent in design, materials, strength and indications to the Consensus Stem (K922561 - Hayes Medical), the Foundation Hip (K991227 - Encore Orthopedics), the Synergy stem (K990369 - Smith & Nephew) and the Summit stem (K013352 - J&J/DePuy).
Device Description
This is a cemented hip stem fabricated from forged cobalt-chromium-molybdenum alloy (CoCrMo) that conforms to ASTM F799. It has a trapezoidal proximal body cross section, tapering both lateral to medial and proximal to distal. The proximal body has a cobra flange along the lateral aspect that helps to apply compressive stresses to the cement. It has a "standard 12/14" Morse type taper to accept modular heads and a neck/shaft angle of 129°. It also has a calcar collar that extends medially only.
The distal stem is conical in shape, tapering proximal to distal end the stem quickly necks down to accept a PMMA distal centralizer is four flanged and is utilized to assure that the distal stem is centered in the femoral canal and a uniform cement mantle is obtained. The distal stem bas four flutes or grooves that increases torsion stability when implanted in cement.
Shallow holes are drilled into the proximal body into which 3m PMMA spacers are pressed. These spacers assure a 3mm cement mantle around the medial, anterior and posterior surfaces.
Intended Use
The PLUS Orthopedics Cemented Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural fead 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.
Summarv Nonclinical Tests
Engineering analysis indicates that this stem will withstand cyclic loads similar to the predicate devices.
Image /page/0/Picture/20 description: The image shows a sequence of alphanumeric characters, specifically 'KO31165'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or printed with a slightly rough texture. The sequence likely represents a code, identifier, or serial number.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2003
PLUS Orthopedics c/o Mr. J.D. Webb Authorized Contact Person 1001 Oakwood Blvd Round Rock, TX 78681
Re: K031165
Trade/Device Name: Plus Orthopedics Cemented Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: April 10, 2003 Received: April 14, 2003
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
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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) 594-4659. 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" (21CFR Part 807.97). 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.
Miriam C. Provost
for 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
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KOSTIFFE 510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PLUS Orthopedics Cemented Hip Stem
Indications for Use:
Cemented Hip Stem Indications for Use
The PLUS Orthopedics Cemented 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.
Miriam C Provost
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K031165
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