510(k) · Cleared
Recalled · Class II · 2024Synthes Ria System (Expanded Indications)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HTO Reamer
Cleared on Aug 10, 2011 as substantially equivalent to K042899 (Synthes (Usa), 2005) after a 78-day review. Its family tree reaches back 1 generation to 2005. It has been recalled 19 times.
- Decided
- Aug 10, 2011
- Review
- 78 days
- Class
- Class I
- Product code
- HTO
- Recalls
- 19
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042899 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK042899 Synthes (Usa) Ria System - Expanded IndicationsSynthes (Usa) · 2005 · Recalled
- This deviceK111437 Synthes Ria System (Expanded Indications)Synthes (USA) Products, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042899 | Synthes (Usa) Ria System - Expanded Indications | Synthes (Usa) | 2005 | 18 |
| 0 (this device) | K111437 | Synthes Ria System (Expanded Indications) | Synthes (USA) Products, LLC | 2011 | — |
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 |
|---|---|---|---|
| * | K042899 | Synthes (Usa) Ria System - Expanded IndicationsSummary page 1…ss 11, 21 CFR §888.4540, Orthopedic manual surgical instrument Product Code: HTO & HRX Pre-dicate Device: Synthes RIA System (K042899) -De-vice Description: Synthes IA System is a flexible intramedullary reaming and bone harvesting… | 2005 |
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 |
| May 28, 2015 | Class II | Z-2092-2015 | Labeling False and Misleading | It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA)… |
The 5 latest of 19 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. 2011, this device’s year, is highlighted.
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 MIA System is intended for use in adults and adolescents
(12-21 years) 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, to harvest finely
morselized autogenous bone and bone marrow for any surgical
procedure requiring bone graft to facilitate fusion and/or fill bone
defects, and to remove infected and necrotic bone and tissue from
the medullary canal in the treatment of osteomyelitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111437 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111437: Synthes Ria System (Expanded Indications).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111437
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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