510(k) · Cleared
ClearedANSER Clavicle Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BAAT Medical Products B.V. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 27, 2020 as substantially equivalent to K182783 (DePuy Synthes, 2018) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Aug 27, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K960642 (1996). 49 ancestors in all, the oldest K903258 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK960642 Nancy NailLandos, Inc. · 1996
- 4 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 3 generations backK081452 Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSynthes (Usa) · 2008
- 2 generations backK082148 Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line…Synthes (Usa) · 2008
- 1 generation backK163488 Flex-Thread Clavicle Pin SystemIntrafuse, LLC · 2017
- This deviceK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −4 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −3 | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | Synthes (Usa) | 2008 | — |
| −2 | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line Extension | Synthes (Usa) | 2008 | — |
| −1 | K163488 | Flex-Thread Clavicle Pin System | Intrafuse, LLC | 2017 | — |
| 0 (this device) | K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K182783 | DePuy Synthes Trauma Orthopedic Nail ImplantsSummary page 5…pin is secured both medially and laterally. 6. Predicate Device(s) The ANSER Clavicle Pin is substantially equivalent to the following devices: Primary Predicate: K182783 DePuySynthes - Elastic Intramedullary Nail (EIN; also known as Titanium Elastic… | 2018 |
| * | K163488 | Flex-Thread Clavicle Pin SystemSummary page 5…PuySynthes - Elastic Intramedullary Nail (EIN; also known as Titanium Elastic Nail or TEN) (primary predicate) Reference Device: K163488 Intrafuse LLC - Flex-Thread Clavicle Pin System (additional predicate) 7. T… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 12 of the 49 ancestors have a recall of any class.
- 1 other device also cites its predicate K182783.
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. 2020, 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 ANSER 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/K201830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201830: ANSER Clavicle Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201830
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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