510(k) · Cleared
Recalled · Class II · 2015Synthes (R) Titanium Small Reconstruction Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Jan 17, 1992 after an 18-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 230 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 17, 1992
- Review
- 18 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 0
230 later devices descend from it, 4 citing it directly.
- This deviceK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992
- Descendant · cites it directly · 127 of its ownK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- Descendant · 2 generations on · 117 of its ownK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- Descendant · 3 generations on · 113 of its ownK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- Descendant · cites it directly · 112 of its ownK981775 Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co. · 1998
- Descendant · 2 generations on · 98 of its ownK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
Showing 5 of 230 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 230 · See all- K990094Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999 · cites it directly127descendants
- K991873Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999 · 2 generations on117descendants
- K021321Wrist Fusion PlateAcu Med, Inc. · 2002 · 3 generations on113descendants
- K981775Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co. · 1998 · cites it directly112descendants
- K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · 2 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | — |
| +1 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| +2 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| +3 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| +1 | K981775 | Depuy Ace Timax Calcaneal Peri-Articular Plate | Depuy Ace Medical Co. | 1998 | — |
| +2 | K033639 | Acumed Lower Extremity Congruent Plate System | Acumed, LLC | 2004 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 7 | 0 |
| 2017 | 19 | 0 |
| 2018 | 5 | 0 |
| 2019 | 10 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 12 | 0 |
| 2023 | 26 | 0 |
| 2024 | 20 | 0 |
| 2025 | 15 | 0 |
| 2026 | 23 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (230)
See all 2304 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 8, 2015 | Class II | Z-0236-2016 | No Marketing Application | The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates.… |
| Jan 27, 2014 | Class II | Z-1174-2014 | Labeling design | Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990094 (Kinetikos Medical, Inc., 1999) has gone furthest, with 127 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
https://510kreport.com/device/K915818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K915818: Synthes (R) Titanium Small Reconstruction Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915818
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026