# K962215: Consensus Posterior Stabilized Knee-Intercondylar Notch Router

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Medical Products, Inc.
- Decided: Aug 15, 1996 after 66 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Whiteside ORTHOLOC II Posterior Stabilized End Mill and Template: named in the summary without a submission number
- (no number) Intermedics Orthopedics Natural Knee II System Posterior Stabilized Router Assembly: named in the summary without a submission number

## Indications for use
The Consensus® Posterior Stabilized Knee system employs a router device to remove the intercondylar bone from the distal portion of the femur. This bone must be removed to accommodate the spine of the posterior stabilized tibial insert. This procedure occurs after all bone resections of the distal femur have been completed in the traditional manner with the existing Consensus® Knee instruments.

Source page: https://510kreport.com/device/K962215
Methodology: https://510kreport.com/methodology