510(k) · Cleared
ClearedPogo Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fxdevices · HWC Screw, Fixation, Bone
Cleared on Nov 25, 2008 as substantially equivalent to K060736 (Smith & Nephew, Inc., 2006) and 1 other predicate after a 263-day review. Its family tree reaches back 3 generations to 1990. 15 later devices descend from it.
- Decided
- Nov 25, 2008
- Review
- 263 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K903810 (1990). 11 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK903810 Ace Cannulated Self Tapping Cancellous Bone ScrewAce Medical Co. · 1990
- 2 generations backK051296 Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005
- 1 generation backK060736 Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 2006 · Recalled
- This deviceK080649 Pogo ScrewFxdevices · 2008
- Descendant · cites it directly · 12 of its ownK152686 Conquest FNSmith & Nephew · 2016
- Descendant · 2 generations on · 10 of its ownK193029 Conquest FNSmith & Nephew, Inc. · 2020
- Descendant · cites it directly · 8 of its ownK172785 Conquest FNSmith & Nephew · 2017
- Descendant · 2 generations on · 7 of its ownK210837 Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · Recalled
- Descendant · 2 generations on · 2 of its ownK213126 Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc…Smith & Nephew, Inc. · 2022 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K152686Conquest FNSmith & Nephew · 2016 · cites it directly12descendants
- K193029Conquest FNSmith & Nephew, Inc. · 2020 · 2 generations on10descendants
- K172785Conquest FNSmith & Nephew · 2017 · cites it directly8descendants
- K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 2021 · 2 generations on7descendants
- K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc. · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903810 | Ace Cannulated Self Tapping Cancellous Bone Screw | Ace Medical Co. | 1990 | — |
| −2 | K051296 | Sijf Cannulated Screw System | Depuy Spine, Inc. | 2005 | — |
| −1 | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated Screws | Smith & Nephew, Inc. | 2006 | 1 |
| 0 (this device) | K080649 | Pogo Screw | Fxdevices | 2008 | — |
| +1 | K152686 | Conquest FN | Smith & Nephew | 2016 | — |
| +2 | K193029 | Conquest FN | Smith & Nephew, Inc. | 2020 | — |
| +1 | K172785 | Conquest FN | Smith & Nephew | 2017 | — |
| +2 | K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021 | 1 |
| +2 | K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100… | Smith & Nephew, Inc. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 22.3 · 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? (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 |
|---|---|---|---|
| * | K060736 | Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSummary page 1…entification of Predicate or Legally Marketed Device The POGO Screw is substantially equivalent to the Smith and Nephew Cannulated Screws cleared under K060736 and the Stryker Medical Asnis III cleared under K071092. 4. Device Description The POGO Screws are compr… | 2006 |
| * | K071092 | Asnis Micro Cannulated ScrewSummary page 1…POGO Screw is substantially equivalent to the Smith and Nephew Cannulated Screws cleared under K060736 and the Stryker Medical Asnis III cleared under K071092. 4. Device Description The POGO Screws are comprised of various size cannulated screws for the fixation… | 2007 |
What descends from it? (15)
See all 154 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 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K152686 (Smith & Nephew, 2016) has gone furthest, with 12 descendants of its own.
- 9 other devices also cite its predicate K060736.
How does its category compare?
All HWC devicesHWC Screw, 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 · 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 POGO Screw is indicated for use in the general management of fractures and
reconstructive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080649 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080649: Pogo Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080649
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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