510(k) · Cleared
ClearedEbi Distal Radius Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · HRS Plate, Fixation, Bone
Cleared on Jun 25, 2004 as substantially equivalent to K000636 (Howmedica Osteonics Corp., 2000) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Jun 25, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000636 (2000). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000636 Stryker Trauma Plating SystemHowmedica Osteonics Corp. · 2000
- This deviceK040908 Ebi Distal Radius Plating SystemEbi, L.P. · 2004
- Descendant · cites it directly · 3 of its ownK093761 Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp) · 2010
- Descendant · 2 generations on · 1 of its ownK150675 Dorsal Spanning PlateSkeletal Dynamics, LLC · 2015
- Descendant · 3 generations on · 0 of its ownK212601 DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022
- Descendant · cites it directly · 0 of its ownK110271 Maestro Wrist Plating SystemBiomet Manufacturing Corp · 2011
Most influential descendants
Showing 4 of 4 · See all- K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp) · 2010 · cites it directly3descendants
- K150675Dorsal Spanning PlateSkeletal Dynamics, LLC · 2015 · 2 generations on1descendant
- K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company · 2022 · 3 generations on0descendants
- K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000636 | Stryker Trauma Plating System | Howmedica Osteonics Corp. | 2000 | — |
| 0 (this device) | K040908 | Ebi Distal Radius Plating System | Ebi, L.P. | 2004 | — |
| +1 | K093761 | Optilock VL (Variable Angle Locking) Distal Radius Plating System | Biomet Trauma (Aka Ebi, Lp) | 2010 | — |
| +2 | K150675 | Dorsal Spanning Plate | Skeletal Dynamics, LLC | 2015 | — |
| +3 | K212601 | DRPx Locking Distal Radius Plate System | Orthopaedic Implant Company | 2022 | — |
| +1 | K110271 | Maestro Wrist Plating System | Biomet Manufacturing Corp | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K000636 | Stryker Trauma Plating SystemSummary page 1…pliances and Accessories, 21 CFR 888.3030 3. Predicate or legally marketed devices that are substantially equivalent: · Stryker Trauma Plating System (K000636) · Hand Innovations Distal Volar Radius Fracture Repair System (K002775)… | 2000 |
| * | K002775 | Distal Volar Radius Fracture Repair SystemSummary page 1…are substantially equivalent: · Stryker Trauma Plating System (K000636) · Hand Innovations Distal Volar Radius Fracture Repair System (K002775) to 4. Description of the device: The EBI® Di… | 2000 |
What descends from it? (4)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
The EBI® Distal Radius Plating System is indicated for the fixation of fractures and osteotomies involving the distal radius.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040908: Ebi Distal Radius Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040908
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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