(241 days)
Signature Orthopaedics Imboki Knee Instrument System are accessory devices intended to be used to assist the implantation of Signature Orthopaedics' World Total Knee System and its cleared indications for use.
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions:
- · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- · Inflammatory degenerative joint disease including rheumatoid arthritis.
- · Functional deformity such as varus, valgus or flexion deformities.
- · Revision procedures where other treatments or devices have failed.
- · Fractures that are unmanageable using other techniques.
The Imboki Knee Instrument System is a simplified instrument set containing accessory devices that are intended to assist in the implantation of Signature Orthopaedics' previously cleared World Total Knee System (K180750).
The Imboki Knee Instrument System consists of manual orthopaedic surgical instruments which are either device-specific or non-device specific. The World Smart Card is a device-specific component which varies in geometry to match the specific dimensions of a particular sized World Knee component. It is a rectangular guide manufactured from acetal polymer as per ASTM F1855 which is assembled with the IM rod to assist with femoral alignment and distal resection. The Imboki Knee Instrument System also includes the same trial instruments as the World Knee previously cleared under 510(k) submission K180750 for the femoral, tibial and patella components. The non-device specific instruments are manufactured from 630 stainless steel as per ASTM A269 or 420 stainless steel as per ASTM F899. All instruments are supplied non-sterile.
The provided text is a 510(k) summary for the Imboki Knee Instrument System, which is an accessory device intended to assist in the implantation of a previously cleared knee system. It explicitly states that clinical data is not required to support the safety and effectiveness of the Imboki Knee Instrument System. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way one might expect for a primary therapeutic or diagnostic device.
The basis for clearance is substantial equivalence to a predicate device (Signature Orthopaedics' World Total Knee System instruments, K180750). The document argues that this new instrument system falls within the scope of validation and verification conducted on the previously cleared system.
Because clinical data was not required for this submission, the following sections will be largely empty or marked as "Not applicable" based on the provided text's explicit statement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified as clinical data was not required. | Not specified. The device's performance is assumed to be substantially equivalent to the predicate device based on its design, materials, and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. Clinical test data was not required for this 510(k) submission. The device's substantial equivalence was based on its similarity to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Clinical test data was not required for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. Clinical test data was not required for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Imboki Knee Instrument System is a set of manual orthopedic surgical instruments, not an algorithm or AI-driven device.
7. The Type of Ground Truth Used
Not applicable. Clinical performance data or ground truth for diagnostic accuracy was not required for this submission. The "ground truth" used for clearance was the established safety and effectiveness of the predicate device, to which the new device was demonstrated as substantially equivalent.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical instrument system, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a mechanical instrument system, not an AI or machine learning model that requires a training set with established ground truth.
§ 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.