(29 days)
No
The 510(k) summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical properties and geometric analysis.
Yes.
The device is intended for total knee arthroplasty procedures to address various knee joint conditions like osteoarthritis, rheumatoid arthritis, and deformities, indicating its use in treating and rehabilitating patients.
No
The provided text describes an implanted device used for total knee arthroplasty procedures, focusing on its physical characteristics, intended use in surgical salvage, and evaluation through mechanical testing, rather than the identification or assessment of a medical condition.
No
The device description clearly describes a physical implantable device (Sleeve Junction Box) made from materials and with specific geometric and mechanical properties, intended for surgical procedures. It does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a device for total knee arthroplasty procedures to address issues like osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, deformities, and revision surgeries. These are all related to surgical intervention and the replacement of a joint.
- Device Description: The device is described as a Sleeve Junction Box for a BKS Revision System, which is part of a total knee arthroplasty system. It's a physical component designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically tests or instruments used in a laboratory or point-of-care setting.
In summary, this device is a surgical implant used in orthopedic procedures, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
-
- 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 of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
The BKS, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.
The BKS is indicated in the salvage of previously failed surgical attempts where 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.
BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications/contraindications requirements.
The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.
The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.
The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.
Product codes
JWH, MBH
Device Description
The purpose of this special 510(k) submission is to request clearance for BKS Revision Sleeve Junction Box of the BKS Revision System which is an extension of Ortho Development's previously cleared predicate BKS Revision Sleeves System (K181569).
The subject device incorporates the same locking taper interface for mating with the BKS Revision Sleeves and the same principle of operation for locking the A/P position relative to the BKS Revision Modular Femoral Component. The subject device is manufactured in the same manner from the same material. The subject device also employs the same packaging components and sterilization method.
Differences between the subject and predicate device include small adjustments to the envelope geometry, internal configuration, and driving feature for assembly during use. These changes have been made to optimize the Sleeve Junction Box for use specifically with femoral sleeves. The mechanics of the connection and locking mechanism are the same as the predicate device.
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
The modified device was evaluated using well established methods and recognized consensus standards to confirm that it meets the original design inputs of the predicate.
The evaluation includes: geometric analysis, axial fatigue strength per ASTM F1814, disassembly strength, assembly evaluation, and packaging evaluation.
These performance data demonstrate that the original design inputs of the predicate are met.
Key Metrics
Not Found
Predicate Device(s)
BKS® Revision Sleeves System (K181569)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2024
Ortho Development Corp. Drew Weaver Director of Regulatory Affairs 12187 S. Business Park Drive Draper, Utah 84020
Re: K242984
Trade/Device Name: BKS Revision System 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: October 25, 2024 Received: September 26, 2024
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 (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.
1
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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 and Part 809); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.
Peter G. Allen -S Allen-S
Digitally signed by Peter G.
Date: 2024.10.25 15:56:31
-04'00'
For: 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
2
Indications for Use
510(k) Number (if known) K242984
Device Name BKS Revision System
Indications for Use (Describe)
-
- 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 of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
The BKS, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.
The BKS is indicated in the salvage of previously failed surgical attempts where 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.
BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications requirements.
The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.
The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.
The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offiset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.
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.
3
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Image /page/4/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a purple circle with gray lines emanating from the top left, followed by the word "ORTHO" in purple block letters. Below "ORTHO" is the word "DEVELOPMENT" in a smaller, lighter font, with a registered trademark symbol.
510(k) Summary of Safety & Effectiveness
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: | October 25, 2024 | |
| Submission Type: | Special | |
| Proprietary Name: | BKS Revision System | |
| Common Name: | BKS Revision Sleeve Junction Box | |
| Product Code /
Classification: | JWH | Prosthesis, knee, patellofemorotibial, semi-
constrained, cemented, polymer/metal/polymer
21 CFR 888.3560: Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis. |
| Associated Product
Code(s) / Classification: | MBH | Prosthesis, knee, patello/femorotibial, semi-
constrained, uncemented, porous, coated,
polymer/metal/polymer
21 CFR 888.3565: Knee joint patellofemorotibial
metal/polymer porous-coated uncemented prosthesis. |
| Device Class: | Class 2 | |
| Primary Predicate
Device: | BKS® Revision Sleeves System (K181569) | |
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Image /page/5/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a purple circle with three curved lines emanating from the top left, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in gray, smaller letters.
1.0 Device Description:
The purpose of this special 510(k) submission is to request clearance for BKS Revision Sleeve Junction Box of the BKS Revision System which is an extension of Ortho Development's previously cleared predicate BKS Revision Sleeves System (K181569).
The subject device incorporates the same locking taper interface for mating with the BKS Revision Sleeves and the same principle of operation for locking the A/P position relative to the BKS Revision Modular Femoral Component. The subject device is manufactured in the same manner from the same material. The subject device also employs the same packaging components and sterilization method.
Differences between the subject and predicate device include small adjustments to the envelope geometry, internal configuration, and driving feature for assembly during use. These changes have been made to optimize the Sleeve Junction Box for use specifically with femoral sleeves. The mechanics of the connection and locking mechanism are the same as the predicate device.
2.0 Indication for Use:
-
- 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 of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
The BKS, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures.
The BKS is indicated in the salvage of previously failed surgical attempts where 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.
BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications/contraindications requirements.
The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.
The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications.
6
Image /page/6/Picture/2 description: The image shows the logo for "Ortho Development". The logo consists of a purple circle with three gray arcs emanating from the left side, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in a smaller, gray font with a trademark symbol.
The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.
3.0 Comparison of Technological Characteristic:
The Sleeve Junction Box is technologically the same as the already cleared Tapered Junction Box that was a component of BKS Revision Sleeves (K181569). It is the same in terms of indications for use/intended use, basic design, device materials, and principles of operation.
Differences between the subject and predicate device include small adjustments to the envelope geometry, internal configuration, and driving feature for assembly during use. These changes have been made to optimize the Sleeve Junction Box for use specifically with femoral sleeves. The mechanics of the connection and locking mechanism are the same as the predicate device.
Labeling, packaging and sterilization do not change.
The modified device was evaluated using well established methods and recognized consensus standards to confirm that it meets the original design inputs of the predicate.
4.0 Performance Data:
The modified device was evaluated using well established methods and recognized consensus standards to confirm that it meets the original design inputs of the predicate.
The evaluation includes: geometric analysis, axial fatigue strength per ASTM F1814, disassembly strength, assembly evaluation, and packaging evaluation.
These performance data demonstrate that the original design inputs of the predicate are met.
5.0 Substantial Equivalence Conclusion:
Verification and validation has been conducted according to design control procedures within a risk analysis framework to determine that the design outputs meet the design inputs using the same test criteria and methodology as the predicate K181569.
Based on similarities in indication for use/intended use, technological characteristic, basic design, device material, and principle of operation, the BKS Revision Sleeve Junction Box of the BKS Revision System is considered substantially equivalent to the previously cleared predicate device.