(73 days)
Not Found
No
The summary describes a passive implant (knee replacement components) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as an implant for partial replacement of articulating surfaces of the knee due to degenerative disease or previous injuries, indicating a therapeutic purpose.
No
The device is described as a knee implant for partial replacement of the knee's articulating surfaces, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description clearly states it is a "unicondylar knee replacement implant" and a "single-use implant intended for implantation with bone cement," indicating it is a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "partial replacement of the articulating surfaces of the knee." This describes a surgical implant used in the body to treat a physical condition.
- Device Description: The description details physical components (femoral knee components) that are implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
This device is a surgical implant used for knee replacement.
N/A
Intended Use / Indications for Use
The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
These devices are single-use implants intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HRY
Device Description
The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM).
The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K041466, K020264, K981996, K971938
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K063515 1/2
Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are thick and bold, with the "T" having a unique design where the horizontal bar is made up of three parallel lines. The overall design gives the word a strong and industrial appearance.
510(k) Summarv
FEB - 2 2007
Inc. Inc. Inc. Inc.
| Preparation Date: | November 20, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Susan Alexander |
| Proprietary Name: | Titanium Repicci II® Unicondylar Femoral Knee Components |
| CoCr Repicci II® Unicondylar Knee | |
| Common Name: | Knee femoral |
| Classification Name: | Prosthesis, Knee Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| (21 CFR §888.3530) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| Titanium Femoral Knee Components
| (Maxim® and AGC®) | K041466 | Biomet |
|---|---|---|
| Repicci II® Unicondylar Knee System | K020264 | Biomet |
| Titanium Femoral Component | K981996 | Biomet |
| Repicci II® Unicondylar Knee | K971938 | Biomet |
Device Description:
The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM).
The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),
Intended Use:
The Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
These devices are single-use implants intended for implantation with bone cement.
Image /page/0/Figure/13 description: This image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581-0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46582. The office number is 574.267.6639, the fax number is 574.267.8187, and the email address is biomet@biomet.com.
5 - 1
1
K063515 2/2
Summary of Technologies: The technological characteristics (material, design and sizing) of the Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee Components are similar or identical to the predicate devices. The indications are exactly the same as the predicate Repicci II® Unicondylar knee systems.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587 FEB - 2 2007
Re: K063515
Trade/Device Name: Titanium Repicci II® Unicondylar Femoral Knee Components and CoCr Repicci II® Unicondylar Knee Components Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: November 20, 2006 Received: November 21, 2006
Dear Ms. Alexander:
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
3
Page 2 - Ms. Susan Alexander
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.
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Brem
Mark N. Melkerson 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): | K063515 |
|---|---|
| --------------------------- | --------- |
Device Name: Titanium Repicci II(® Unicondylar Femoral Knee Components CoCr Repicci II® Unicondylar Knee
Indications For Use:
The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
These devices are single-use implants intended for implantation with bone cement.
Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Snehl D. MCN
(Division Sign. or Org.)
Division of General, Restorative, and Neurological Devices
510(k) Number