510(k) · Cleared
Recalled · Class II · 2024Modification to Synthes (Usa) 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 Dec 21, 2001 as substantially equivalent to K993335 (Synthes (Usa), 2000) after a 59-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 18 times.
- Decided
- Dec 21, 2001
- Review
- 59 days
- Class
- Class I
- Product code
- HTO
- Recalls
- 18
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993335 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK993335 Synthes Reamer/Irrigator/Aspirator (Ria) SystemSynthes (Usa) · 2000 · Recalled
- This deviceK013527 Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) SystemSynthes (Usa) · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993335 | Synthes Reamer/Irrigator/Aspirator (Ria) System | Synthes (Usa) | 2000 | 17 |
| 0 (this device) | K013527 | Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) System | Synthes (Usa) | 2001 | — |
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? (1)
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 |
|---|---|---|---|
| * | K993335 | Synthes Reamer/Irrigator/Aspirator (Ria) SystemSummary page 1…Aspirator (RIA) System Class II, 21 CFR 888.4540 and 888.1100 Orthopedic manual surgical instrument; Arthroscope Synthes (USA) Reamer Irrigator Aspirator (RIA) System, K993335 Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2024 | Class II | Z-1237-2024 | Process control | Products not sterilized, sterility cannot be confirmed |
| 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 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
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/K013527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013527: Modification to Synthes (Usa) Reamer Irrigator Aspirator (Ria) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013527
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026