510(k) · Cleared
Recalled · Class II · 2024Synthes (Usa) Ria System - Expanded Indications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HTO Reamer
Cleared on Mar 16, 2005 after a 147-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 18 times.
- Decided
- Mar 16, 2005
- Review
- 147 days
- Class
- Class I
- Product code
- HTO
- Recalls
- 18
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK042899 Synthes (Usa) Ria System - Expanded IndicationsSynthes (Usa) · 2005
- Descendant · cites it directly · 0 of its ownK111437 Synthes Ria System (Expanded Indications)Synthes (USA) Products, LLC · 2011 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K111437Synthes Ria System (Expanded Indications)Synthes (USA) Products, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042899 | Synthes (Usa) Ria System - Expanded Indications | Synthes (Usa) | 2005 | — |
| +1 | K111437 | Synthes Ria System (Expanded Indications) | Synthes (USA) Products, LLC | 2011 | 19 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (2)
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 RIA System Named without a submission number | |
| * | — | Spine-Tech Bone Harvester 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 |
|---|---|---|---|
| K111437 | Synthes Ria System (Expanded Indications) | 2011 | 0 |
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?
- Of its descendants, K111437 (Synthes (USA) Products, LLC, 2011) 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; 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042899: Synthes (Usa) 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/K042899
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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