# K042899: Synthes (Usa) Ria System - Expanded Indications

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 16, 2005 after 147 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
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 RIA System: named in the summary without a submission number
- (no number) Spine-Tech Bone Harvester: named in the summary without a submission number

## Most influential descendants
- K111437: Synthes Ria System (Expanded Indications) (2011), 0 descendants of its own

## 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; and to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, and tumor removal.

Source page: https://510kreport.com/device/K042899
Methodology: https://510kreport.com/methodology