(29 days)
No
The summary describes a mechanical implant with changes to geometry and material, with no mention of AI or ML.
No.
The device is a non-cemented femoral component for hip replacement surgery due to degenerative joint disease, indicating it replaces or restores a body part rather than treating a disease or condition.
No
The device is a femoral component used in hip replacement surgery, which is a therapeutic intervention, not a diagnostic procedure.
No
The device description clearly states it is a femoral component made from titanium alloy, which is a hardware implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "primary hip replacement surgery," which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "femoral component," which is an implantable medical device used in hip replacement surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Product codes
LPH
Device Description
The X-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® 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. An oblong insertion hole replaces the predicate round insertion hole in order to provide the surgeon with more control during insertion.
For the new lateralized style, the difference in the two series lies in the horizontal offsets and neck angle. The offset is increased and therefore the distance from the center of the modular head to the center of the stem is also increased. The taper trunion or post is angled at 130° on the modified device whereas the post of the predicate device is at 135°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
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: Mechanical testing was 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)
Bi-Metric® Hip Femoral Component (K921224)
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
MAR 2 2 2002
Image /page/0/Picture/2 description: The image shows the logo for BIOMET CORPORATE HEADQUARTERS. The word BIOMET is in a stylized font with thick, black lines. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller, serif font.
Summary of Safety and Effectiveness
Applicant/Sponsor: Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist Phone: (574) 267-6639
Proprietary Name: X-Series Bi-Metric® Hip Femoral Components
Common Name: Hip replacement prosthesis
Classification Name: Prosthesis, hip, semi-constrained, metal/polymer, porous coated uncemented (888.3558
Legally Marketed Device to which Substantial Equivalence is Claimed: Bi-Metric® Hip Femoral Component (K921224)
Device Description: The X-Series Bi-Metric® femoral components are identical to the predicate Bi-Metric® 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. An oblong insertion hole replaces the predicate round insertion hole in order to provide the surgeon with more control during insertion.
For the new lateralized style, the difference in the two series lies in the horizontal offsets and neck angle. The offset is increased and therefore the distance from the center of the modular head to the center of the stem is also increased. The taper trunion or post is angled at 130° on the modified device whereas the post of the predicate device is at 135°.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
Image /page/0/Picture/17 description: The image shows the number 000135 in a bold, sans-serif font. The numbers are evenly spaced and aligned horizontally. The image is a close-up of the numbers, with no other objects or background elements visible.
1
Intended Use: Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the X-Series Bi-Metric femoral components are similar to or identical to the predicate device.
Non-Clinical Testing: Mechanical testing was conducted to insure the design changes would not effect the safety of the device.
Clinical Testing: None provided
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AR 2 2 2002
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K020580
Trade/Device Name: X-Series Bi-Metric® Hip Femoral Components Regulation Number: 21 CFR §888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: February 20, 2002 Received: February 21, 2002
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suned in the encreat 1976, the enactment date of the Medical Device Amendments, or to conninered prior to rial) 2011-07-2017 accordance with the provisions of the Federal Food, Drug, de nees mat have been route 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 I ou may, arorely 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 If your device is classinod (too arotrols. Existing major regulations affecting your device can may or buyer to back are are are are and 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 nean r rouse be actived and i bromination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 Of R Part 8077, acomig (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.
R. Mch. A. Mchllum
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
4
510(k) Number (if known): __ KO20580
Device Name: X-Series Bi-Metric Femoral Components
Indications For Use:
Indications For OSE.
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Madk.M.Melle
(Division Sign-Off) Division of General, Res rative and Neurological Devices KO2OSBU
510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801709)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
000005