AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN

• K Number: K033489
• Device Name: AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
• Manufacturer: BIOMET, INC.
• Date Cleared: 2004-06-02 ( 211 days)
• Product Code: MBH
• Regulation Number: 888.3565
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K833921 , K912245 , K982869 , K994326 , K915132 , K023546 , K031462 , K030612 , K030623

Intended Use

The indications for Biomet's Non-Cemented Porous Coated Knee Components include:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, where one or more compartments are involved.
2. Correction of varus, valgus or posttraumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

Device Description

All devices are metallic knee femoral and tibial base-plate components. The components are identical to those cleared in previous 510(k) submissions for cemented application.

The porous coated components that are subject of this 510(k) are intended for use with components (tibial bearings, all polyethylene patellar components, non-porous coated femoral and tibial base-plates) previously covered by 510(k) submission for cemented use.

AI/ML Overview

This 510(k) summary for the Biomet's Non-Cemented Porous Coated Knee Components explicitly states "Clinical and Non-Clinical Testing: None provided." Therefore, there is no study described in this document that proves the device meets acceptance criteria.

The submission is based on substantial equivalence to predicate devices that were previously cleared for cemented application. The current submission seeks clearance for non-cemented application of the same metallic knee femoral and tibial base-plate components.

As no testing was provided, the following information cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided as no testing was submitted.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, no studies were done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no testing and thus no ground truth establishment for a test set occurred.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
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.(b)
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.