# K013527: Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) System

- Pathway: 510(k) (Special)
- Applicant: Synthes (Usa)
- Decided: Dec 21, 2001 after 59 days
- Product code: HTO (Reamer)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993335 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993335: Synthes Reamer/Irrigator/Aspirator (Ria) System, Synthes (Usa) (2000) Summary page 1.

## Recalls of this device
- Jan 24, 2024 · Class II · Z-1237-2024: Products not sterilized, sterility cannot be confirmed
- Nov 19, 2020 · Class II · Z-0572-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0577-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0583-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0584-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0586-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0571-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0585-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0573-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0578-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0579-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0580-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0587-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0574-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0575-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0576-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0581-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
- Nov 19, 2020 · Class II · Z-0582-2021: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

## Indications for use
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.

Source page: https://510kreport.com/device/K013527
Methodology: https://510kreport.com/methodology