(199 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a femoral component intended for total joint replacement to treat various degenerative joint diseases and fractures, which is a therapeutic purpose.
No
Explanation: The device is a femoral component intended for joint replacement, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states that the device is a physical implantable component made from titanium alloy, which is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various conditions of the hip joint and femur. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically placed in the body. This is consistent with a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a physical implant used to treat a condition.
N/A
Intended Use / Indications for Use
The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use 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 joint replacement.
Product codes
LPH, JDI, LZO, KWY, KWZ,
Device Description
The XR-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® X-Series femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-620. The stem diameters and lengths are identical. The product offering has been expanded to include reduced proximal profile devices. All devices have a trapezoidal, polished neck.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral
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
Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not affect the safety of the device.
Clinical Testing: None provided
Key Metrics
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
FEB 1 7 2006
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
|---|---|
| Contact Person: | Patricia Sandborn Beres |
| Senior Regulatory Specialist | |
| Proprietary Name: | XR-Series Bi-Metric® Femoral Components |
| Common Name: | Hip joint replacement device |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous |
coated יות מש uncemented prosthesis.
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Bi-Metrix® X-Series Hip Femoral Components, originally cleared by 510(k) K020580, 03/22/02 and cleared for expanded indications by 510(k) K030055, 8/11/03.
Device Description: The XR-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® X-Series femoral components in overall geometry. Both device series are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-620. The stem diameters and lengths are identical. The product offering has been expanded to include reduced proximal profile devices. All devices have a trapezoidal, polished neck.
Intended Use: The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 1)
-
- Rheumatoid arthritis
- Correction of functional deformity 3)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal 4) femur with head involvement, unmanageable by other techniques.
-
- Revision of previously failed total joint replacement.
Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the XR-Series Bi-Metric® Femoral Components are similar to or identical to the predicate device or other previously cleared devices.
Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not affect the safety of the device.
Clinical Testing: None provided
Date Prepared: January 30, 2006
All trademarks are property of Biomet, Inc.
MAILING ADDRESS --------------------------------------------------------------------------------------------------------------------------------------------------------------1 - 1 - PO -Box - 887
Warsaw, IN -10581-0551 - 1 - 1 - 1 - 3 - 36 - Wansaw, IN -1658,
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SHIPPING ADDRESS Warsaw, I'N 16583
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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K052089
Trade/Device Name: XR-Series Bi-Metric Femoral Components Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: LPH, JDI, LZO, KWY, KWZ, Dated: February 1, 2006 Received: February 2, 2006
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 for ass stated in 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 r va may, ateres, mains 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 11 your de rise is onable (in al controls. Existing major regulations affecting your device can may or datyed to battle to begulations, 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 i read on a made a determination that your device complies with other requirements of the Act that + Dr daral statutes and regulations administered by other Federal agencies. You must or uny I oderal battler and 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
2
Page 2 - Ms. Patricia Sandborn Beres
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bysteins (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) This letter will anow you to ocgin mailiemlig of substantial equivalence of your device to a legally premarket notification: "The Price is 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 rryou desire specific as no liance at (240) 276-0120. Also, please note the regulation entitled, Coliable of Collied of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Herbert Leuer 19
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K052089
Device Name: XR-Series Bi-Metric® Femoral Components
Indications For Use: The XR-Series Bi-Metric® Femoral Components are intended for cemented or uncemented use in cases of:
- cemented of uncemented use in odood on
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Correction of functional dolormis)
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the Treatment of non anion, fornerament, unmanageable by other techniques.
-
- Revision of previously failed total joint replacement.
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 |
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510(k) Number_________________________________________________________________________________________________________________________________________________________________