(206 days)
No
The 510(k) summary describes a mechanical knee implant component made of UHMWPE. There is no mention of software, algorithms, image processing, AI, or ML. The function is purely mechanical restoration of the knee joint.
Yes.
The device is designed to restore function and replace diseased/arthritic knees, which is a therapeutic purpose.
No
This device, the Balanced Knee® System, is described as a replacement for diseased and arthritic knees, functioning to restore function. Its indications for use relate to treating existing conditions and replacing structures, not to diagnosing conditions.
No
The device description clearly details a physical implant made of UHMWPE, which is a hardware component.
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 a knee replacement system for patients suffering from severe knee pain and disability due to various conditions. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The description details a physical implantable device made of UHMWPE, designed to replace parts of the knee joint.
- Function: The function is described as "restoration of function as a replacement for diseased and arthritic knees," which is a therapeutic function, not a diagnostic one.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
Therefore, the Ortho Development Balanced Knee® System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ortho Development Balanced Knee® System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to:
-
- Loss of joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities.
-
- Revision procedures where other treatments or devices have failed.
The Balanced Knee® System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.
Product codes
JWH
Device Description
The Balanced Knee System Ultracongruent Tibial Insert may be used in conjunction with the Balanced Knee System CR femorals, standard and modular tibial trays, tibial augments, stems, and patellae. The Ultracongruent Tibial Insert has an anterior lip and tighter anterior curvature to stabilize the knee in the anterior direction and are snap fitted into the tibial trays and locked in place by mating features, the circumferential rim of the tray, and tabs on the anterior and posterior sides. The Ultraconqruent Tibial Insert is available in seven sizes to fit the majority of patients encountered. The sizes match each size of the Balanced Knee System tibial trays cleared under Premarket Notifications K994370, K020383, and K031201. The insert is symmetric, not left/right specific. It is supplied in thicknesses of 7, 8, 9, 10, 11, 12, 13. 14. 16. 18. and 20mm.
Materials: The device is manufactured from Compression Molded Ultra High Molecular Weight Polyethylene (UHMWPE, ASTM F-648). Function: The system functions to provide restoration of function as a replacement for diseased and arthritic knees.
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)
The Food and Drug Administration have established no performance standards applicable to the Ultracongruent Tibial Insert, however biomechanical testing and analysis of the device was performed with results included as part of the submission. Clinical data and conclusion were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K994770, K033272, P830055, K923277, K001456, K001456, K951987, K000586, K872379, K912663, K936159
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
OCT ~ 9 2009
Image /page/0/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a circular graphic to the left of the text. The graphic contains three curved lines that appear to be orbiting a central point. Below the words "Ortho Development" is the phrase "engineering simplicity" in a smaller font.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS:
Submitter:
ﺎ ﻓ
Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020
Contact Person:
Johanne Young Manger, Quality Assurance and Regulatory/Clinical Affairs (801) 619-3450 Telephone: Fax: (801) 619-8950
Date Prepared:
October 5, 2009
Name of the Device
| Trade Name: | Balanced Knee System® Ultracongruent Tibial Insert |
|---|---|
| Common Name: | Knee Joint Prosthesis |
| Classification Name: | Prosthesis, Knee patellofemorotibial, Semi-constrained |
| Cemented, Polymer/Metal/Polymer (888.3560) | |
| Product Code: | JWH |
Predicate or legally marketed devices which are substantially equivalent:
- Ortho Development Corporation Balanced Knee System CR or PS Insert � (K994770)
- Depuy Sigma Deep Dish Insert (K033272) .
- Depuy LCS Deep Dish Bearing (P830055) .
- Encore Medical Foundation Ultracongruent Insert (K923277) .
- Hayes Medical Concensus Ultracongruent Insert (K001456) .
- OMNI Life Science Apex Knee Ultracongruent Insert (K001456) .
- Smith & Nephew Genesis II Dished Insert (K951987) .
- Smith & Nephew (Plus Orthopedics) TC-PLUS Solution Ultracongruent Insert . (Коореве)
- Zimmer Insall-Bernstein PSCK Tibial Insert (K872379) .
- Zimmer (Intermedics) Natural Knee II Ultracongruent and PS Insert . (K912663, K936159)
1
Description of the device:
The Balanced Knee System Ultracongruent Tibial Insert may be used in conjunction with the Balanced Knee System CR femorals, standard and modular tibial trays, tibial augments, stems, and patellae. The Ultracongruent Tibial Insert has an anterior lip and tighter anterior curvature to stabilize the knee in the anterior direction and are snap fitted into the tibial trays and locked in place by mating features, the circumferential rim of the tray, and tabs on the anterior and posterior sides. The Ultraconqruent Tibial Insert is available in seven sizes to fit the majority of patients encountered. The sizes match each size of the Balanced Knee System tibial trays cleared under Premarket Notifications K994370, K020383, and K031201. The insert is symmetric, not left/right specific. It is supplied in thicknesses of 7, 8, 9, 10, 11, 12, 13. 14. 16. 18. and 20mm.
Materials: The device is manufactured from Compression Molded Ultra High Molecular Weight Polyethylene (UHMWPE, ASTM F-648). Function:
The system functions to provide restoration of function as a replacement for diseased and arthritic knees.
Intended Use:
The Ortho Development Balanced Knee™ System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to:
-
- Loss of joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities.
-
- Revision procedures where other treatments or devices have failed.
The Balanced Knee® System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.
Performance Testing:
The Food and Drug Administration have established no performance standards applicable to the Ultracongruent Tibial Insert, however biomechanical testing and analysis of the device was performed with results included as part of the submission. Clinical data and conclusion were not needed for this device.
Basis for substantial equivalency:
There are no significant differences between the components of the Ortho Development Ultracongruent Tibial Insert and other commercially available tibial inserts listed in the substantial equivalency section currently being marketed, which would adversely affect the use of the product. Testing met all acceptance criteria and verifies that the performance of the Ultracongruent Tibial Insert is substantially equivalent in design, function, material and intended use to the predicate devices.
INTENDED USE/INDICATIONS
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 features a stylized depiction of an eagle or bird in flight, composed of several curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ortho Development Corporation % Ms. Johanne Young Manager, Quality Assurance & Regulatory/Clinical Affairs 12187 South Business Park Drive Draper, Utah 84020
OCT - 9 2009
Re: K090705
Trade Name: Balanced Knee System Ultracongruent Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH
Dated: August 20, 2009 Received: August 21, 2009
Dear Ms. Young:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Johanne Young
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
fel
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 Indications for Use Statement
Indications for Use of Device Form
1090705
510(k) Number (if known):
Device Name: Balanced Knee® System Ultracongruent Tibial Insert
Indications for Use
The Ortho Development Balanced Knee® System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to:
-
- Loss of joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities.
-
- Revision procedures where other treatments or devices have failed.
The Balanced Knee® System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart C)
(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices
510(k) Number