510(k) · Cleared
ClearedEnsplintcmx Clavicle Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoma Orthopedic Products, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Oct 10, 2008 as substantially equivalent to K991649 (Depuy, Inc., 1999) after a 105-day review. Its family tree reaches back 2 generations to 1990. 4 later devices descend from it.
- Decided
- Oct 10, 2008
- Review
- 105 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903258 (1990). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK903258 Hagie PinOnyx Medical Corp. · 1990
- 1 generation backK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
- This deviceK081832 Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK100112 Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy…Sonoma Orthopedic Products, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK163488 Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020
- Descendant · cites it directly · 0 of its ownK111550 Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac…Sonoma Orthopedic Products, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K100112Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM)Sonoma Orthopedic Products, Inc. · 2010 · cites it directly2descendants
- K163488Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017 · cites it directly1descendant
- K201830ANSER Clavicle PinBAAT Medical Products B.V. · 2020 · 2 generations on0descendants
- K111550Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia…Sonoma Orthopedic Products, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903258 | Hagie Pin | Onyx Medical Corp. | 1990 | — |
| −1 | K991649 | Depuy Rockwood Clavicle Pin | Depuy, Inc. | 1999 | — |
| 0 (this device) | K081832 | Ensplintcmx Clavicle Pin | Sonoma Orthopedic Products, Inc. | 2008 | — |
| +1 | K100112 | Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia… | Sonoma Orthopedic Products, Inc. | 2010 | — |
| +1 | K163488 | Flex-Thread Clavicle Pin System | Intrafuse, LLC | 2017 | — |
| +2 | K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020 | — |
| +1 | K111550 | Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy… | Sonoma Orthopedic Products, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K991649 | Depuy Rockwood Clavicle PinSummary page 1…on, Threaded 21 CFR 888.3040 Predicate Device DePuy Rockwood TM Clavicle Pin K991649, cleared July 14, 1999 Description of device The EnsplintCMXTM configuration consists of… | 1999 |
What descends from it? (4)
3 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K100112 (Sonoma Orthopedic Products, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K991649.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The ENSPLINTCMxTM Clavicle Pin is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081832: Ensplintcmx Clavicle Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081832
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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