510(k) · Cleared
ClearedRetrograde Pediatric Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · HTY Pin, Fixation, Smooth
Cleared on Aug 11, 1998 after a 159-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- Aug 11, 1998
- Review
- 159 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK980854 Retrograde Pediatric NailEncore Orthopedics, Inc. · 1998
- Descendant · cites it directly · 15 of its ownK020885 Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 14 of its ownK041393 Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 7 of its ownK111232 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 6 of its ownK160545 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016
- Descendant · 3 generations on · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K020885Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · cites it directly15descendants
- K041393Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · 2 generations on14descendants
- K111232Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · 2 generations on7descendants
- K160545Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016 · 2 generations on6descendants
- K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980854 | Retrograde Pediatric Nail | Encore Orthopedics, Inc. | 1998 | — |
| +1 | K020885 | Fassire-Duval Telescopic IM System | Pega Medical, Inc. | 2003 | 4 |
| +2 | K041393 | Fassier-Duval Telscopic IM System | Pega Medical, Inc. | 2004 | 5 |
| +2 | K111232 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2012 | 1 |
| +2 | K160545 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2016 | — |
| +3 | K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020885 | Fassire-Duval Telescopic IM System | 2003 | 15 |
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, K020885 (Pega Medical, Inc., 2003) has gone furthest, with 15 descendants of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The indications for use of the Retrograde Pediatric Nail include: use in fractures of the femur, tibia and humerus with retrograde applications. Applications would be available in any patients where the growth plate would not be compromised.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980854: Retrograde Pediatric Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980854
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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