510(k) · Cleared
ClearedDC Ulnar Shortening System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopro, LLC · HRS Plate, Fixation, Bone
Cleared on Feb 29, 2008 after a 106-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Feb 29, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK073228 DC Ulnar Shortening SystemOrthopro, LLC · 2008
- Descendant · cites it directly · 3 of its ownK113364 2.7MM LCP Ulna Osteotomy SystemSynthes (USA) Products, LLC · 2012 · Recalled
- Descendant · cites it directly · 1 of its ownK130008 Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol)…I.T.S. GmbH · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K1133642.7MM LCP Ulna Osteotomy SystemSynthes (USA) Products, LLC · 2012 · cites it directly3descendants
- K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH · 2013 · cites it directly1descendant
- K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · 2 generations on0descendants
- K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073228 | DC Ulnar Shortening System | Orthopro, LLC | 2008 | — |
| +1 | K113364 | 2.7MM LCP Ulna Osteotomy System | Synthes (USA) Products, LLC | 2012 | 1 |
| +1 | K130008 | Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0… | I.T.S. GmbH | 2013 | 1 |
| +2 | K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with… | I.T.S. GmbH | 2026 | — |
| +2 | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
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?
- Of its descendants, K113364 (Synthes (USA) Products, LLC, 2012) has gone furthest, with 3 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. 2008, this device’s year, is highlighted.
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 DC Ulnar Shortening System provides fixation for osteotomies of the ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073228: DC Ulnar Shortening System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073228
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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