510(k) · Cleared
ClearedEasy Out
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Feet For Life Podiatry Center · HWC Screw, Fixation, Bone
Cleared on Feb 20, 2015 as substantially equivalent to K051605 (Small Bone Innovations, LLC, 2005) and 3 other predicates after a 268-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Feb 20, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K000684 (2000). 23 ancestors in all, the oldest K874669 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- 4 generations backK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
- 3 generations backK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- 2 generations backK140508 Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc. · 2014
- 1 generation backK143066 Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions…Zimmer, Inc. · 2014
- This deviceK141401 Easy OutFeet For Life Podiatry Center · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| −4 | K063303 | Universal Locking System, 2.7MM Plates & Screws | Zimmer, Inc. | 2006 | 4 |
| −3 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| −2 | K140508 | Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws | Zimmer, Inc. | 2014 | — |
| −1 | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions… | Zimmer, Inc. | 2014 | — |
| 0 (this device) | K141401 | Easy Out | Feet For Life Podiatry Center | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K051605 | Sbi K-WiresSummary page 4…ification Panel: Orthopedic Product Code: HWC Device Class: II 5. Legally Marketed Predicate Device(s) Small Bone Innovations, Inc. SBI K-Wires (510(k) Number K051605, cleared August 10, 2005) Zimmer®, Inc. Zimmer® Plates and Screws System (ZPS) – Non-Sterile, Sterile/ Non-Sterile ZPS Scre… | 2005 |
| * | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile… Cleared while this submission was under review Summary page 4…er K051605, cleared August 10, 2005) Zimmer®, Inc. Zimmer® Plates and Screws System (ZPS) – Non-Sterile, Sterile/ Non-Sterile ZPS Screws and Washers (510(k) Number K143066, cleared November 28, 2014) Stryker® Corporation Asnis™ Micro Cannulated Screw (formally Howmedica Osteonics Corp.) (510(k)… | 2014 |
| * | K071092 | Asnis Micro Cannulated ScrewSummary page 4…Washers (510(k) Number K143066, cleared November 28, 2014) Stryker® Corporation Asnis™ Micro Cannulated Screw (formally Howmedica Osteonics Corp.) (510(k) Number: K071092) 2.0mm and 3.0mm diameter implants Page 5-1… | 2007 |
| * | K024060 | Modification to Asnis Iii Cannulated Screw SystemSummary page 5…K141401 Page 2 of 3 Stryker® Corporation, Asnis™ III Cannulated Screws (510(k) Number K024060, cleared December 20, 2002) 6. Device Description Easy Out™ system consists of various, partially threaded solid screws d… | 2002 |
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 15 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 23 ancestors have a recall of any class.
- 5 other devices also cite its predicate K051605.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Easy Out™ system is indicated for temporary internal fixation and stabilization of osteotomies and fractures during normal healing of ankle, elbow and small bones such as those in the foot and wrist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141401: Easy Out.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141401
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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