Who is the manufacturer of Balanced Knee Revision System Trabecular Tibial Cone Augments?

Ortho Development Corporation filed the 510(k) submission for Balanced Knee Revision System Trabecular Tibial Cone Augments (K182085).

What is the FDA product code for Balanced Knee Revision System Trabecular Tibial Cone Augments?

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Balanced Knee Revision System Trabecular Tibial Cone Augments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Balanced Knee Revision System Trabecular Tibial Cone Augments?

Trabecular Metal Tibial Cone Augments (K053340, K102896).

Who can help prepare an FDA 510(k) submission like Balanced Knee Revision System Trabecular Tibial Cone Augments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Balanced Knee Revision System Trabecular Tibial Cone Augments

K182085 · Ortho Development Corporation · JWH · Oct 31, 2018 · Orthopedic

Device Facts

Record ID	K182085
Device Name	Balanced Knee Revision System Trabecular Tibial Cone Augments
Applicant	Ortho Development Corporation
Product Code	JWH · Orthopedic
Decision Date	Oct 31, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

These devices are intended for use in total knee arthroplasty procedures for the following conditions: 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. The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions. The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.

Device Story

Modular tibial cone augment implants; used in revision knee arthroplasty to provide proximal tibial reinforcement and support when bone voids exist. Implants designed for cemented or cementless fixation. Used by orthopedic surgeons in clinical/OR settings. Output is physical structural support for tibial prosthesis; aids in restoring joint stability and function in salvage procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included tibial construct fatigue (ASTM F2083, F1800), static compression, mechanical testing (ASTM F1044, F1147, F1160), porous structure analysis (ASTM F1854), material properties (ASTM F136, F3001), abrasion resistance (ASTM F1978), and bacterial endotoxin testing (ANSI/AAMI ST72).

Technological Characteristics

Modular tibial cone augments; porous structure; cemented or cementless fixation. Materials conform to ASTM F136 and ASTM F3001. Testing standards: ASTM F2083, F1800, F1044, F1147, F1160, F1854, F1978. Sterilization method not specified.

Indications for Use

Indicated for patients undergoing total knee arthroplasty or revision procedures requiring bone loss management due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or joint deformities (valgus, varus, flexion).

Regulatory Classification

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).

Predicate Devices

Trabecular Metal Tibial Cone Augments (K053340, K102896)

Reference Devices

Tesera Trabecular Technology (T³) Acetabular Shell System (K132312)

Related Devices

K094017 — TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 · Omni Life Science, Inc. · Mar 5, 2010
K120990 — NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL · Zimmer Trabecular Metal Technology · Jun 29, 2012
K152494 — Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments · Zimmer, Inc. · Nov 25, 2015
K170149 — 3DMetal Tibial Cones · Medacta International S.A. · Aug 18, 2017
K071417 — DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES · DePuy Orthopaedics, Inc. · Aug 2, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Ortho Development Corporation Adrienne Von Foller Sr. Regulatory Affairs Specialist 12187 So. Business Park Drive Draper, Utah 84020 October 31, 2018 Re: K182085 Trade/Device Name: Balanced Knee Revision System Trabecular Tibial Cone Augments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: August 1, 2018 Received: August 2, 2018 Dear Adrienne Von Foller: 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. 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 located 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. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > Sincerely, Daniel S. Ramsey -S 2018.10.31 14:59:18 -04'00' For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K182085 #### Device Name Balanced Knee® Revision System Trabecular Tibial Cone Augments Indications for Use (Describe) These devices are intended for use in total knee arthroplasty procedures for the following conditions: - 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. The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions. The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use. | Type of Use (Select one or both, as applicable) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table><tr><td><div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div></td></tr><tr><td><div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | ### 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." {3}------------------------------------------------ 12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax 553-9993 Orthodevelopment.com Image /page/3/Picture/2 description: The image shows the logo for "Ortho Development". The logo is purple and features a stylized "O" shape with gray arcs above it. The text "ORTHO" is written in capital letters to the right of the "O" shape, and the word "DEVELOPMENT" is written in smaller letters below the "ORTHO" text. # 510(k) Summary | Name of Sponsor: | Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact: | Adrienne von Foller Senior Regulatory Affairs Specialist Telephone: (801) 619-8933 Email: RA@OrthoDevelopment.com | | Date Prepared: | July 30, 2018 | | Submission Type: | Traditional 510(k) | | Proprietary Name: | Balanced Knee® Revision System Trabecular Tibial Cone Augments | | Common Name: | Knee Joint Replacement Prosthesis | | Classification: | 21 CFR 888.3560: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis | | Device Class: | Class II | | Device Product Code: | JWH, MBH | | Predicate Device: | K053340, K102896 - Trabecular Metal Tibial Cone Augments; Zimmer®, Inc. | | Reference Device: | K132312 – Tesera Trabecular Technology (T³) Acetabular Shell System; Renovis® Surgical Technologies, Inc. | #### 5.1 Device Description The Balanced Knee® Revision System (BKS® Revision) Trabecular Tibial Cone Augments are an addition to the Balanced Knee® Revision System to provide optional single-use modular cone augment implants used in revision knee surgery. The subject device provides additional support to the tibial implant and reinforcement to the proximal tibia when bone voids are present. The subject device is designed for cemented or uncemented fixation with the bone. {4}------------------------------------------------ ## 5.2 Indications for Use The subject device is intended for use in total knee arthroplasty procedures for the following conditions: - 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. The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions. The BKS Revision System Trabecular Tibial Cone Augments are for cementless use. ## 5.3 Basis for Substantial Equivalence: The BKS® Revision Trabecular Tibial Cone Augments have technological characteristics as the predicate device. These include: - 1. Indications for use - 2. Intended use - 3. Basic principles of operation - 4. Basic design - 5. Sterilization The following non-clinical tests were conducted and successfully met the predetermined acceptance criteria: - 1. Tibial construct fatigue per ASTM F2083 and ASTM F1800 - 2. Static compression - 3. Mechanical testing per ASTM F1044, ASTM F1147, and ASTM F1160 - 4. Porous structure analysis per ASTM F1854 - 5. Tensile properties and composition of material per ASTM F136 and ASTM F3001 - 6. Abrasion resistance per ASTM F1978 - 7. Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72 Note: Where testing was performed according to a recognized consensus standard, the designation number of the standard is referenced above. The fundamental scientific technology of the BKS® Revision Trabecular Tibial Cone Augments is the same as the previously cleared predicate. The test results further demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate. No clinical studies were deemed necessary for a determination of substantial equivalence. The intended use of the subject device is the same as the predicate. Based on similarities in indications for use, basic design, and the principle of operation, the BKS® Revision Trabecular Tibial Cone Augments are substantially equivalent to the previously cleared predicate device.