# K990816: Avcore System

- Pathway: 510(k) (Traditional)
- Applicant: Modular Cutting Systems, Inc.
- Decided: Sep 24, 1999 after 197 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) Trephines manufactured by Gambale & Merrill: named in the summary without a submission number

## Indications for use
The AV Core System is a system of cannulated trephines and drills used to obtain and insert a tailored bone graft into a matched hole in the femoral head. The use of the system is indicated for patients suffering from Avascular Necrosis, but in which the head does not radiologically show signs of gross collapse or degerative changes.

Source page: https://510kreport.com/device/K990816
Methodology: https://510kreport.com/methodology