(21 days)
Not Found
No
The description focuses on the mechanical design and materials of a modular revision stem, with no mention of AI or ML technology.
No
The device is a revision stem intended to anchor into the femur to fix fractures, indicating it replaces or supports a body part, which is a prosthetic function rather than a direct therapeutic function.
No
The device is a revision stem for use in femoral fractures, not a tool for diagnosis.
No
The device description clearly describes a physical implantable medical device made of Ti-6Al-4V alloy, consisting of a modular stem with distal and proximal components. It does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The provided text describes a surgical implant (a revision stem for the femur) that is intended for use inside the human body to treat bone fractures. It is a physical device implanted during surgery.
The description clearly indicates a device used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.
Product codes
LWJ
Device Description
The Modular PLUS Revision Stem is a cementless two part modular stem that consists of distal anchorage module and proximal revision module, connected by a multi-stage tapered coupling, secured by a cylindrical screw.
The proximal module has a standard 12/14 taper to accept modular heads.
The Modular PLUS stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um.
This submission adds three additional proximal modules, designated as size AX, BX and CX, have the same circumferential dimensions as the previously cleared AS/AL, BS/BL and CS/CL proximal modules. The differences lie in the overall length of the components. The AX module increases by 15.4mm, the BX module by 18.7mm and the CX module by 22.7mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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)
Engineering analysis shows that the bending stresses in the taper connection are less for the modified, longer modules.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
2 3 2003
510(k) Summary
Date
August 28, 2003
Submitter
PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name
Hip stem
Classification name
Prosthesis, hip, semi-constrained, metal/polymer, uncemented per 21 CFR Sec. 888.3360
Equivalent Device
The modifications to this device continue to be equivalent in design, fundamental scientific technology, indications and material to the Modular PLUS stem cleared on K030971.
Device Description
The Modular PLUS Revision Stem is a cementless two part modular stem that consists of distal anchorage module and proximal revision module, connected by a multi-stage tapered coupling, secured by a cylindrical screw.
The proximal module has a standard 12/14 taper to accept modular heads.
The Modular PLUS stem is manufactured from Ti-6Al-4V alloy that conforms to ASTM F136. The surface is grit blasted with corundum to produce a surface roughness of 4-6um.
This submission adds three additional proximal modules, designated as size AX, BX and CX, have the same circumferential dimensions as the previously cleared AS/AL, BS/BL and CS/CL proximal modules. The differences lie in the overall length of the components. The AX module increases by 15.4mm, the BX module by 18.7mm and the CX module by 22.7mm.
Intended Use
The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.
Summary of Technological Characteristics Compared to Predicate Device
The modifications to this device continue to be equivalent in design, fundamental scientific technology, indications and material to the Modular PLUS stem cleared on K030971.
Summary Nonclinical Tests
Engineering analysis shows that the bending stresses in the taper connection are less for the modified, longer modules.
032709
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle, which is the symbol of the HHS.
Public Health Service
SEP 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PLUS Orthopedics c/o Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K032709
Trade/Device Name: Modular PLUS Revision Stem Regulation Numbers: 21 CFR 888.3360 Regulation Names: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LWJ Dated: August 28, 2003 Received: September 2, 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 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.
2
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) 594-4659. 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 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 N. Milkeson
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): _ K032709
Device Name:
Indications for Use:
Modular PLUS Revision Stem Indications for Use
The Modular PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of the bone is damaged and the stem must anchor into the distal half of the femur.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional format 1-2-96)
for Mark A. Milken
ivision of General, Restorative and Neurological Devices
(k) Number K032709