Balanced Knee System TriMax Porous Femoral Components
Device Facts
| Record ID | K253161 |
|---|---|
| Device Name | Balanced Knee System TriMax Porous Femoral Components |
| Applicant | Ortho Development Corp. |
| Product Code | MBH · Orthopedic |
| Decision Date | Dec 19, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3565 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed.
Device Story
Balanced Knee System TriMax Porous Femoral Components are cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral implants used in total knee arthroplasty (TKA). The device replaces worn or damaged knee joint surfaces. It features a sintered porous coating on bone-contacting surfaces to facilitate uncemented fixation, though it remains compatible with cemented use. Available in Cruciate Retaining (CR) and Posterior Stabilized (PS) configurations, the device comes in various sizes to match patient anatomy. Surgeons implant the device in an operating room. The device functions as a mechanical replacement for the femoral component of the knee joint, restoring joint configuration and function. Benefits include relief of pain and restoration of mobility for patients with degenerative or traumatic knee conditions.
Clinical Evidence
No clinical testing was performed. Safety and effectiveness were established through non-clinical bench testing, including range of motion (ASTM F2083), femorotibial/patellofemoral constraint and contact area (ASTM F1223, F1672, F2083), femoral fatigue strength (ASTM F3210), wear testing (ISO 14243), and extensive porous coating characterization (ASTM F1854, F1044, F1147, F1978, F1160).
Technological Characteristics
Material: Cast Co-Cr-Mo alloy (ASTM F75). Features: Sintered porous coating on bone-contacting surfaces. Configurations: Cruciate Retaining (CR) and Posterior Stabilized (PS). Sterilization: Gamma radiation (ISO 11137, SAL 10^-6). Dimensions: Medial-lateral width 56–79.5mm; anterior-posterior width 50–74mm. Mechanical testing standards: ASTM F2083, F1223, F1672, F3210, ISO 14243.
Indications for Use
Indicated for patients requiring total knee arthroplasty due to loss of joint function/configuration, osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, valgus/varus/flexion deformities, or revision procedures.
Regulatory Classification
Identification
A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
Predicate Devices
- Balanced Knee® System TriMax® CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts (K152169)
Reference Devices
- Balanced Knee® System High Flex PS (K123457)
- Maxx Orthopedics, Freedom® Cementless Femoral Component (K150680)
- BKS® High Flex PS Tibial Inserts (K131337)
- BKS® TriMax® PS Plus Tibial Inserts (K233093)
Related Devices
- K051380 — TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM · Howmedica Osteonics Corp. · Aug 30, 2005
- K073529 — DEPUY SIGMA PS FEMORAL COMPONENTS · DePuy Orthopaedics, Inc. · Jan 24, 2008
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite · Howmedica Osteonics Corp. · May 13, 2020
- K073325 — LEGION POROUS PRIMARY · Smith & Nephew, Inc. · Dec 20, 2007
- K152169 — Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts · Ortho Development Corporation · Oct 27, 2015
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
December 19, 2025
Ortho Development Corporation
Drew Weaver
Director of Regulatory Affairs
12187 S. Business Park Drive
Draper, Utah 84020
Re: K253161
Trade/Device Name: Balanced Knee System TriMax Porous Femoral Components
Regulation Number: 21 CFR 888.3565
Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis
Regulatory Class: Class II
Product Code: MBH, JWH
Dated: September 25, 2025
Received: September 26, 2025
Dear Drew Weaver:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253161 - Drew Weaver
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253161 - Drew Weaver
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu -S
Lixin Liu, Ph.D
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253161 | |
| Device Name Balanced Knee® System TriMax® Porous Femoral Components | |
| Indications for Use (Describe) | |
| Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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12187 So. Business Park Drive
Draper, Utah 8402
801-553-9991/fax 553-999
Orthodevelopment.com
K253161 (Page 1 of 4)
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ORTHO
DEVELOPMENT
# 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Name of the Sponsor: | Ortho Development® Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
| --- | --- |
| 510(k) Contact: | Name: Drew Weaver
Position: Director of Regulatory Affairs
Address: 12187 S. Business Park Drive
Draper, UT 84020 USA
Telephone: (801) 553-9991
Email: dweaver@orthodevelopment.com |
| Date Prepared: | November 26, 2025 |
| Submission Type: | Traditional |
| Proprietary Name: | Balanced Knee® System TriMax® Porous Femoral Components |
| Common Name: | Knee Femoral Prosthesis
(Co-Cr-Mo sintered porous coated knee femoral prosthesis) |
| Product Code / Classification: | MBH 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. |
| Associated Product Code(s) / Classification: | JWH 21 CFR 888.3560: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
| Device Class: | Class II |
| Primary Predicate Device: | Balanced Knee® System TriMax® CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts (K152169) |
| Reference Device: | Balanced Knee® System High Flex PS (K123457)
Maxx Orthopedics, Freedom® Cementless Femoral Component (K150680) |
Balanced Knee® System TriMax® Porous Femoral Components - 510(k) Summary – Page 1 of 4
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12187 So. Business Park Drive
Draper, Utah 8402
801-553-9991/fax 553-999
Orthodevelopment.com
K253161 (Page 2 of 4)
ORTHO DEVELOPMENT
# 1.0 Device Description:
Balanced Knee® System TriMax® Porous Femoral Components are intended for use as part of total knee arthroplasty (TKA) procedures. Total knee arthroplasty is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.
The components are prescription products consisting of single use devices for implanting into patients in an operating room by a qualified surgeon.
Balanced Knee® System TriMax® Porous Femoral Components are a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component with Co-Cr-Mo sintered porous coating.
The device will have two configurations:
- Cruciate Retaining (CR) Femoral – (Substantially Equivalent to K152169)
- Posterior Stabilized (PS) Femoral – (Substantially Equivalent to K123457)
They have the same materials of constructions and the same articular geometry as the legally marketed TriMax cemented femoral components. The new feature is the addition of the CoCr porous coating on the bone contacting surfaces that is substantially equivalent to the reference device: Maxx Orthopedics Freedom Porous Femoral Component (K150680).
Balanced Knee® System TriMax® Porous Femoral Components are manufactured from cast Co-Cr-Mo per ASTM F75.
The subject device has a variety of sizes to accommodate variations in patient anatomies: left and right orientations, medial-lateral width (56 – 79.5mm), anterior-posterior width (50 – 74mm), and CR & PS variations.
Balanced Knee® System TriMax® Porous Femoral Components are compatible with BKS® High Flex PS Tibial Inserts (K123457, K131337), BKS® High Flex Patellar Button (K131337), BKS® TriMax® CR and US Tibial Inserts (K152169), and BKS® TriMax® PS Plus Tibial Inserts (K233093).
# 2.0 Indication for Use:
Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications:
1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.
Balanced Knee® System TriMax® Porous Femoral Components - 510(k) Summary – Page 2 of 4
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12187 So. Business Park Drive
Draper, Utah 8402
801-553-9991/fax 553-999
Orthodevelopment.com
K253161 (Page 3 of 4)
ORTHO
DEVELOPMENT
## 3.0 Comparison of Technological Characteristic:
Balanced Knee® System TriMax® Porous Femoral Components come in two variations:
- Cruciate Retaining (CR) Femoral – (Substantially Equivalent to K152169)
- Posterior Stabilized (PS) Femoral – (Substantially Equivalent to K123457)
They are manufactured out of Co-Cr-Mo alloy by the same suppliers as these previously cleared devices with the exception of the new porous coating. They have the same articular geometry as these previously cleared devices.
The Co-Cr-Mo porous coating is the same as the previously cleared reference device: Maxx Orthopedics Freedom Porous Femoral Component (K150680).
## 4.0 Performance Data:
### Sterilization
Balanced Knee® System TriMax® Porous Femoral Components are gamma radiation sterilized and are validated to a sterility assurance level of $10^{-6}$ in accordance with the ISO 11137.
### Shelf Life
The packaging for Balanced Knee® System TriMax® Porous Femoral Components are validated in accordance with ASTM D4169.
### Biocompatibility
Balanced Knee® System TriMax® Porous Femoral Component’s biocompatibility was established according to the requirements of ISO 10993-1 and found to be safe for its intended use.
### Mechanical Testing
The following non-clinical mechanical tests and analyses were conducted on the subject device.
| Range of Motion Test (ASTM F2083) | ASTM F2083 |
| --- | --- |
| Femorotibial Constraint (ASTM F1223) | ASTM F1223 |
| Femorotibial Contact Area (ASTM F2083) | ASTM F2083 |
| Patellofemoral Constraint (ASTM F1672) | ASTM F1672 |
| Patellofemoral Contact Area (ASTM F1672) | ASTM F1672 |
| Femoral Fatigue Strength (ASTM 3210) | ASTM F3210 |
| Wear Testing (ISO 14243) | ISO 14243 |
| Porous Coating Characterization | ASTM F1854 |
Balanced Knee® System TriMax® Porous Femoral Components - 510(k) Summary – Page 3 of 4
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12187 So. Business Park Drive
Draper, Utah 8402
801-553-9991/fax 553-999
Orthodevelopment.com
K253161 (Page 4 of 4)
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ORTHO
DEVELOPMENT
| Porous Coating Static Shear and Tensile | ASTM F1044 & F1147 |
| --- | --- |
| Porous Coating Abrasion | ASTM F1978 |
| Porous Coating Shear Fatigue | ASTM F1160 |
## Clinical Testing
No clinical testing is required to establish the safety and effectiveness of Balanced Knee® System TriMax® Porous Femoral Components.
## 5.0 Substantial Equivalence Conclusion:
Verification and validation activities were conducted to establish the performance of Balanced Knee® System TriMax® Porous Femoral Components. The results of verification and validation activities demonstrate that Balanced Knee® System TriMax® Porous Femoral Components are as safe and effective and perform as well as the legally marketed predicates.
Based on similarities in indication for use/intended use, technological characteristic, basic design, device material, and principle of operation, Balanced Knee® System TriMax® Porous Femoral Components are considered substantially equivalent to the previously cleared predicate devices.
Balanced Knee® System TriMax® Porous Femoral Components - 510(k) Summary – Page 4 of 4
