(20 days)
No
The summary describes a mechanical knee implant and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for addressing painful and disabled knee joints, correcting deformities, and revising unsuccessful prior procedures, all of which fall under therapeutic interventions.
No
This device is a knee joint replacement (tibial component) used for treating painful and disabled knee joints, not for diagnosing conditions.
No
The device description clearly details a physical implant made of polyethylene and Co-Cr-Mo, intended for surgical implantation in the knee joint. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a knee implant used for surgical replacement of a damaged knee joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The description focuses on the materials, design, and surgical application of the device, which are characteristic of a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Fixed Bearing Uni Components are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Fixed Bearing Uni Components are for use with bone cement.
Product codes
HRY
Device Description
The tibial component consists of polyethylene plateau molded over a one-piece Co-Cr-Mo base and central keel. The molded tibial components are anatomical in geometry with right and left medical/lateral allocations. The overall form of the implant is tear-shaped. The Fixed Bearing Uni Components will be used in conjunction with the Oxford Unicompartmental Knee Femoral Component (K011138) and the Repicci IITM Unicondylar Knee (K971938).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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: Engineering Justifications, Mechanical Testing, and a Finite Element Analysis (FEA) determined that the Fixed Bearing Uni Components presented no new risks and was, therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.
0
JUN 0 5 2002
Image /page/0/Picture/1 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 printed in a smaller, sans-serif font. The text is all in black and the background is white.
page 1 of 2
Koolbool
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley
Telephone: (574) 267-6639 |
| Proprietary Name: | Fixed Bearing Uni Component |
Common Name: Molded Uni Tibial Bearing
Classification: Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.3530)
Device Classification: Class II
Legally Marketed Device to which Substantially Equivalence is Claimed: Repicci IITM Unicondylar Knee (K971938)
Device Description: The tibial component consists of polyethylene plateau molded over a one-piece Co-Cr-Mo base and central keel. The molded tibial components are anatomical in geometry with right and left medical/lateral allocations. The overall form of the implant is tear-shaped.
The Fixed Bearing Uni Components will be used in conjunction with the Oxford Unicompartmental Knee Femoral Component (K011138) and the Repicci IITM Unicondylar Knee (K971938).
Indications for Use: The indications for the Fixed Bearing Uni Components are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Fixed Bearing Uni Components are for use with bone cement.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
프
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639 FAX 219.267.8137
00022
1
Summary of Technologies: The Fixed Bearing Uni Components -the materials, design, sizing, and indications are similar or identical to the predicate devices.
Non-Clinical Testing: Engineering Justifications, Mechanical Testing, and a Finite Element Analysis (FEA) determined that the Fixed Bearing Uni Components presented no new risks and was, therefore, substantially equivalent to the predicate device.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
JUN 0 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dalene T. Binkley Regulatory Affairs Specialist . Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K021621
Trade Name: Fixed Bearing Uni Component Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: April 26 2002 Received: May 16, 2002
Dear Ms. Binkley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Dalene T. Binklev
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 vours.
Sincerely yours,
Mark N Millers
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
Page _ of _
510 (k) NUMBER (if KNOWN): _ KO2 1621_
DEVICE NAME: Fixed Bearing Uni Component
INDICATIONS FOR USE:
The Fixed Bearing Uni Component is indicated for use for 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
This device is intended to be used with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Comments of the manage of the management of the comments of the programment of the management of the management of the management of the manufacturer | ||
|---|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
Prescription Use ☑
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)
for Mark N. Melkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K021621
ONAB