510(k) · Cleared
ClearedFassier-Duval Telescopic IM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pega Medical, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on May 26, 2021 as substantially equivalent to K020885 (Pega Medical, Inc., 2003) and 1 other predicate after a 28-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.
- Decided
- May 26, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960642 (1996). 6 ancestors in all, the oldest K813371 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960642 Nancy NailLandos, Inc. · 1996
- 3 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 2 generations backK020885 Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · Recalled
- 1 generation backK041393 Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · Recalled
- This deviceK211292 Fassier-Duval Telescopic IM SystemPega Medical, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK241983 Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical · 2025
- Descendant · cites it directly · 0 of its ownK232648 RODEO Telescopic NailOrthofix Srl · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −3 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −2 | K020885 | Fassire-Duval Telescopic IM System | Pega Medical, Inc. | 2003 | 4 |
| −1 | K041393 | Fassier-Duval Telscopic IM System | Pega Medical, Inc. | 2004 | 5 |
| 0 (this device) | K211292 | Fassier-Duval Telescopic IM System | Pega Medical, Inc. | 2021 | — |
| +1 | K241983 | Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical | 2025 | — |
| +1 | K232648 | RODEO Telescopic Nail | Orthofix Srl | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K020885 | Fassire-Duval Telescopic IM SystemSummary page 4…cal characteristics (materials, design, sizing) of the Fassier-Duval Telescopic IM System are identical to the predicate Pega Medical Fassier-Duval Telescopic IM System (K020885 & K041393). The rationale for substantial equivalence is based on consideration of the following characteristics: • Intended U… | 2003 |
| * | K041393 | Fassier-Duval Telscopic IM SystemSummary page 4…teristics (materials, design, sizing) of the Fassier-Duval Telescopic IM System are identical to the predicate Pega Medical Fassier-Duval Telescopic IM System (K020885 & K041393). The rationale for substantial equivalence is based on consideration of the following characteristics: • Intended Use: The in… | 2004 |
What descends from it? (2)
2 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 25 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K241983 (Orthopediatrics Canada Ulc Dba Pega Medical, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K020885.
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. 2021, 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?
This implant is indicated as a temporary implant to aid in the healing of long diaphysis fractures, osteotomies, malunions and nonunions and to prevent further fractures in femur, tibia and humerus in pediatric patients suffering from Osteogenesis Imperfecta without disrupting the bone growth plate. It can be used in procedures such as bone lengthening/shortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.
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/K211292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211292: Fassier-Duval Telescopic IM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211292
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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