510(k) · Cleared
Recalled · Class II · 2020Synthes Reamer/Irrigator/Aspirator (Ria) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HTO Reamer
Cleared on Jun 12, 2000 after a 252-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 17 times.
- Decided
- Jun 12, 2000
- Review
- 252 days
- Class
- Class I
- Product code
- HTO
- Recalls
- 17
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993335 Synthes Reamer/Irrigator/Aspirator (Ria) SystemSynthes (Usa) · 2000
- Descendant · cites it directly · 0 of its ownK013527 Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) SystemSynthes (Usa) · 2001 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K013527Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) SystemSynthes (Usa) · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993335 | Synthes Reamer/Irrigator/Aspirator (Ria) System | Synthes (Usa) | 2000 | — |
| +1 | K013527 | Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) System | Synthes (Usa) | 2001 | 18 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Synthes Intramedullary Reamers Named without a submission number | |
| * | — | Zimmer's Flexible Intramedullary Reamer Named without a submission number | |
| * | — | Davol's Pneumatic Arthroscopy Pulsed Irrigator System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013527 | Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) System | 2001 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2020 | Class II | Z-0572-2021 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 | Use error | 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 |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013527 (Synthes (Usa), 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HTO devicesHTO Reamer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTO
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · HTO
Too few HTO 510(k)s in any year since 2007 to give a median.
Recalls per year · HTO
17in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTO
1,046in 2025
MAUDE reports naming product code HTO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 31 |
| 2008 | 0 | — | 1 | 76 |
| 2009 | 0 | — | 0 | 81 |
| 2010 | 0 | — | 21 | 90 |
| 2011 | 1 | — | 2 | 79 |
| 2012 | 0 | — | 3 | 162 |
| 2013 | 0 | — | 1 | 523 |
| 2014 | 0 | — | 1 | 405 |
| 2015 | 0 | — | 1 | 655 |
| 2016 | 0 | — | 7 | 1,039 |
| 2017 | 0 | — | 7 | 1,234 |
| 2018 | 0 | — | 1 | 1,835 |
| 2019 | 0 | — | 0 | 1,955 |
| 2020 | 0 | — | 17 | 1,531 |
| 2021 | 0 | — | 0 | 4,802 |
| 2022 | 0 | — | 0 | 3,909 |
| 2023 | 0 | — | 0 | 4,401 |
| 2024 | 0 | — | 0 | 4,746 |
| 2025 | 0 | — | 0 | 1,046 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993335 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993335: Synthes Reamer/Irrigator/Aspirator (Ria) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993335
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026