(155 days)
No
The summary describes a mechanical knee implant made of specific materials and designed for increased range of motion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
This device is a total knee arthroplasty component, which is used to restore joint function and configuration, addressing various knee joint conditions. This functional restoration and treatment of disease classify it as a therapeutic device.
No
This device is a prosthetic implant (tibial insert and patella) used in total knee arthroplasty procedures for the treatment of various knee joint conditions, rather than for diagnosing them.
No
The device description clearly states that the device is a physical implant (tibial insert and patella) made from UHMWPE, intended for surgical implantation in total knee arthroplasty. It is not software.
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 use in "cemented total knee arthroplasty procedures." This is a surgical procedure performed on a patient's body.
- Device Description: The device is described as a "tibial insert and patella," which are components of a knee implant. These are physical devices implanted into the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such testing on bodily specimens.
The device is a surgical implant used to replace parts of the knee joint, which falls under the category of medical devices used in vivo (within the living body), not in vitro (in glass, or outside the living body).
N/A
Intended Use / Indications for Use
The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following.indications:
-
- Loss of knee joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint. 3.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
- Revision procedures where other treatments or devices have failed. 6.
Product codes (comma separated list FDA assigned to the subject device)
OIY, JWH
Device Description
The Balanced Knee® System High Flex Vitamin E (High Flex Vit E) PS tibial insert and patella are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE. Both components are single use only. The High Flex Vit E PS tibial insert must be used in conjunction with the High Flex PS femoral component (K123457). Used together, these components are designed to accommodate increased range of motion up to 150° of flexion. The High Flex Vit E patella may be used in conjunction with the Balanced Knee® System (BKS) femoral components (K994370), the BKS modular femoral components (K060569), or the High Flex PS femoral components (K123457). Both the High Flex Vit E PS tibial insert and patella may be used in conjunction with the BKS standard and modular tibial trays, tibial augments, and stems to complete the semi-constrained modular knee prosthesis. The tibial trays, tibial augments, and stems were approved under K994370 and K031201.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical testing was performed to determined substantial equivalence to the predicate devices:
- Range of Motion: Up to 150° flexion; Substantially Equivalent to predicate device, BKS High, Flex
- Femorotibial Constraint: Substantially Equivalent to predicate device, BKS High Flex
- Femorotibial Contact Area: Substantially Equivalent to predicate device, BKS High Flex
- Patellofemoral Constraint: Substantially Equivalent to predicate device, BKS High Flex
- Patellofemoral Contact Area: Substantially Equivalent to predicate device, BKS High Flex
- PS Spine Fatigue: Substantially Equivalent
- Insert Assembly/Disassembly: Substantially Equivalent
- Crosslinking Characterization of High Flex Vit E: Substantially equivalent or better than BKS
- Vitamin E Characterization of High Flex Vit E: Substantially equivalent or better than BKS
- High Flex Knee Wear: Decrease in wear over BKS
Ortho Development believes that the High Flex Vit E PS tibial insert and patella are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.
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.
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.
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
§ 888.3560 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
510(k) Summary
| NAME OF SPONSOR: | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | ------------------ | -- |
510(k) CONTACT:
Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020
.
Total Knee Replacement Prosthesis
Tom Haueter Regulatory Affairs Manager Telephone: (801) 553-9991 Facsimile: (801) 553-9993 Email: thaueter@orthodevelopment.com
OCT 11 2013
DATE PREPARED:
PROPRIETARY NAME:
Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella
COMMON NAME:
CLASSIFICATION:
21 CFR 888.3560, Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis, Class II device
DEVICE PRODUCT CODE:
PREDICATE DEVICES:
OIY, JWH
April 24, 2013
Balanced Knee® System (K994370), Ortho Development Corp.
Balanced Knee® System High Flex PS (K123457), Ortho Development Corp.
Highly Cross-Linked Vitamin E UHMWPE Tibial Insert (K091956), DJO Surgical/Encore Medical
High Flex Vit E 510(k)
Section 5, 510(k) Summary
1
K131337 (2/3)
- Device Description
The Balanced Knee® System High Flex Vitamin E (High Flex Vit E) PS tibial insert and patella are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE. Both components are single use only. The High Flex Vit E PS tibial insert must be used in conjunction with the High Flex PS femoral component (K123457). Used together, these components are designed to accommodate increased range of motion up to 150° of flexion. The High Flex Vit E patella may be used in conjunction with the Balanced Knee® System (BKS) femoral components (K994370), the BKS modular femoral components (K060569), or the High Flex PS femoral components (K123457). Both the High Flex Vit E PS tibial insert and patella may be used in conjunction with the BKS standard and modular tibial trays, tibial augments, and stems to complete the semi-constrained modular knee prosthesis. The tibial trays, tibial augments, and stems were approved under K994370 and K031201.
Intended Use
The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following indications:
-
- Loss of knee joint configuration and joint function.
- Osteoarthritis of the knee joint. 2.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
- ഗ് Valgus, varus, or flexion deformities of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
Technological Characteristics
| Feature | Equivalent Device |
|---|---|
| Indications for Use and Design | Ortho Development: Balanced Knee® System (K994370) |
| Ortho Development: Balanced Knee® System High Flex PS (K123457) | |
| Material: Extensively Crosslinked Vitamin E | |
| Polyethylene UHMWPE (α-tocopherol) | DJO Surgical/Encore Medical: Vit E UHMWPE Tibial Insert (K091956) |
There is only one difference between the High Flex Vit E PS insert when compared to the BKS High Flex PS insert: the implementation of a different material, crosslinked Vitamin E UHMWPE. Likewise, the High Flex Vit E patella is identical to the BKS patella except for the crosslinked Vitamin E UHMWPE material. The indications for use for the High Flex Vit E PS tibial insert and patella are identical to the indications for use for the BKS High Flex. The crosslinked Vitamin E UHMWPE for the High Flex Vit E PS insert and patella undergoes substantially equivalent fabrication and final processing as its predicate, DJO/Encore's Vitamin E UHMWPE tibial insert.
2
Performance Data
The following non-clinical testing was performed to determined substantial equivalence to the predicate devices:
| Property | Result |
|---|---|
| Range of Motion | Up to 150° flexion; Substantially Equivalent to predicate device, BKS High, |
| Flex | |
| Femorotibial | |
| Constraint | Substantially Equivalent to predicate device, BKS High Flex |
| Femorotibial | |
| Contact Area | Substantially Equivalent to predicate device, BKS High Flex |
| Patellofemoral | |
| Constraint | Substantially Equivalent to predicate device, BKS High Flex |
| Patellofemoral | |
| Contact Area | Substantially Equivalent to predicate device, BKS High Flex |
| PS Spine Fatigue | Substantially Equivalent |
| Insert Assembly/ | |
| Disassembly | Substantially Equivalent |
| Crosslinking | |
| Characterization of | |
| High Flex Vit E | Substantially equivalent or better than BKS |
| Vitamin E | |
| Characterization of | |
| High Flex Vit E | Substantially equivalent or better than BKS |
| High Flex Knee Wear | Decrease in wear over BKS |
Basis for Substantial Equivalence
Ortho Development believes that the High Flex Vit E PS tibial insert and patella are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.
.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with a single snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gho9 Silver Spring, MIJ 20993-0002
October 11, 2013
Ortho Development Corporation Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020
Re: K131337
Trade/Device Name: Balanced Knee* System High Flex Vitamin E PS Tibial Insert and Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patcllofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY Dated: September 6, 2013 Received: September 9, 2013
Dear Mr. Haucter:
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
4
Page 2 - Mr. Tom Haueter
CFR Part 807); labeling (21 CFR Part 801); medical device 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Sincercly yours,
Image /page/4/Picture/7 description: The image shows the name "Erin I. Keith" in a bold, sans-serif font. The name is presented in a single line, with the first name "Erin" clearly visible. The middle initial "I." is followed by the last name "Keith", completing the full name displayed in the image.
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use Form Ortho Development Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella 510(k)
510(k) Number (if known): _K131337
Device Name: Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella
Indications for Use:
The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following.indications:
-
- Loss of knee joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint. 3.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
- Revision procedures where other treatments or devices have failed. 6.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices