# K960685: Orthodoc Preoperative Planner Model 500

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Surgical Systems, Inc.
- Decided: Jan 17, 1997 after 332 days
- Product code: HWT (Template)
- Device class: 1
- Regulation: 21 CFR 888.4800
- 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) Depuy AML templates: named in the summary without a submission number
- (no number) Howmedica Osteolock HA templates: named in the summary without a submission number

## Indications for use
The ORTHODOC Preoperative Planner is a software device indicated for the planning of primary total hip arthroplasties on a personal computer. The software is intended to import compurted tomography data, provide a constructed image of the data, and use computerized files, representing implant patterns of femoral components, to overlay the constructed image to aid surgeons in their selection and positioning of the femoral components.

Source page: https://510kreport.com/device/K960685
Methodology: https://510kreport.com/methodology