(104 days)
Not Found
No
The summary describes a mechanical implant (femoral component for hip replacement) and its material properties. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML medical devices.
Yes
The device is a non-cemented total joint replacement for various orthopedic conditions, which are therapeutic interventions.
No
Explanation: The device is described as a "femoral component" for "total joint replacement," indicating it is an implantable medical device used for treatment, not for diagnosing a condition.
No
The device description explicitly states it is a physical implant manufactured from titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that this device is a femoral component for total joint replacement. This is an implantable medical device used within the body during surgery.
- Intended Use: The intended uses listed are all related to surgical procedures for treating conditions affecting the hip joint.
Therefore, based on the description and intended use, this device is a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Non-cemented total joint replacement in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed total hip arthroplasty
Product codes
LPH
Device Description
The X-Series Integral® RPP Femoral Components are identical to the predicate X-Series Integral® Femoral components in overall design. The X-Series Integral® RPP Femoral Components have a reduced proximal geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (femoral components of hip replacement prosthesis)
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)
Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device.
Clinical Testing: None provided
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
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NOV - 9 2004
BIOMET
K04-2029
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist Phone: (574) 267-6639
Proprietary Name: X-Series Integral® RPP Hip Femoral Components
Common Name: Hip replacement prosthesis
Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (21 CFR 888.3558)
Legally Marketed Device to which Substantial Equivalence is Claimed: X-Series Integral® Hip Femoral Component (K030501)
Device Description: The X-Series Integral® RPP Femoral Components are identical to the predicate X-Series Integral® Femoral components in overall design. The X-Series Integral® RPP Femoral Components have a reduced proximal geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136.
Indications for Use: Non-cemented total joint replacement in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
- Correction of functional deformity 3)
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed total hip arthroplasty
Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Integral® femoral components are similar to or identical to the predicate device.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
()FFICE 574.267.6639
Image /page/0/Picture/22 description: The image shows the word "FAX" at the top, followed by the number "574.267.8137" on the next line. Below that, the number "127" is printed in a larger, bold font. The image appears to be a snippet from a document, possibly a fax cover sheet or a document containing contact information.
E-MAH biomet@biomet.com
1
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Non-Clinical Testing: Finite Element Analysis and engineering analysis were conducted to insure the design changes would not effect the safety of the device.
Clinical Testing: None provided
Integral is a trademark of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an abstract image of an eagle with three lines representing its wings. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 2004
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
Re: K042029
Ko42027
Trade/Device Name: X-Series Integral® Reduced Proximal Profile (RPP) Femoral Components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prostheses. Regulatory Class: II Product Code: LPH Dated: October 11, 2004 Received: October 12, 2004
Dear Ms. Beres:
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.
3
Page 2 - Ms. Patricia Sandborn Beres
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and hy your he 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 (240) 276-0120. 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,
L. 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
4
Indications for Use
510(k) Number (if known):
Device Name: X-Series Integral® RPP Femoral Components
Indications For Use:
Non-cemented total joint replacement in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed total hip arthroplasty
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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, Restorative,
and Neurological Devices
510(k) Number K0402029
Ko 92029 MN
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