# K011715: Macropore IB Resorbable Plug

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Aug 27, 2001 after 84 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K974017 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010529: Titanium Cement Restrictor Material Pldla, Medtronic Sofamor Danek USA, Inc. (2001) Summary page 2.
- K003718: Titanium Cement Restrictor (TCR), Medtronic Sofamor Danek, Inc. (2001) Summary page 2.
- K994158: Macrosorbos Protective Sheet, Macropore Biosurgery, Inc. (2000) Summary page 2.

## Indications for use
MacroPore IR Resarbable Plng is indicated for use as a cement restrictor in the femur, tibia and humerus.

Source page: https://510kreport.com/device/K011715
Methodology: https://510kreport.com/methodology