# K993335: Synthes Reamer/Irrigator/Aspirator (Ria) System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 12, 2000 after 252 days
- Product code: HTO (Reamer)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Synthes Intramedullary Reamers: named in the summary without a submission number
- (no number) Zimmer's Flexible Intramedullary Reamer: named in the summary without a submission number
- (no number) Davol's Pneumatic Arthroscopy Pulsed Irrigator System: named in the summary without a submission number

## Most influential descendants
- K013527: Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) System (2001), 0 descendants of its own

## Recalls of this device
- 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/K993335
Methodology: https://510kreport.com/methodology