Regulatory requirements

If you implement only ISO 10328 you will not be in total compliance with required parts od FDA regulation. ISO 10328 is a standard for Structural testing of lower-limb prostheses — Requirements and test methods, and does not have any part to deal with quality management system described in 21 CFR 820, reports of correction and removals described in 21 CFR 806; registration described in 21 CFR 807, Unique Device identification described in 21 CFR 830 or electronic records and signatures described in 21 CFR 11.

Can they implement 13485/10328 with your ISO 13485:2016 Documentation Toolkit and will be OK with FDA requirements?
If your ISO 13485:2016 Documentation Toolkit is not enough to reach this goal, what else is needed?

If the company implements ISO 13485/10328, with our ISO 13485:2016 Documentation Toolkit the following requirements from the FDA will be met: quality management system described in 21 CFR 820, and reports of correction and removals described in 21 CFR 806. The following requirements need to be fulfilled in addition to our toolkit: registration described in 21 CFR 807, Unique Device identification described in 21 CFR 830 or electronic records and signatures described in 21 CFR 11.

For more information, please read the following article: 

How to use ISO 13485 to fulfill FDA regulatory classes for medical devices https://advisera.com/13485academy/blog/2017/09/14/how-to-use-iso-13485-to-fulfill-fda-regulatory-classes-for-medical-devices/