510(k) · Cleared
ClearedFassier-Duval Telescoping IM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopediatrics Canada Ulc Dba Pega Medical · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 21, 2025 as substantially equivalent to K211292 (Pega Medical, Inc., 2021) and 3 other predicates after a 228-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Feb 21, 2025
- Review
- 228 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K960642 (1996). 17 ancestors in all, the oldest K813371 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK960642 Nancy NailLandos, Inc. · 1996
- 6 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 5 generations backK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
- 4 generations backK081097 Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC · 2008
- 3 generations backK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
- 2 generations backK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled
- 1 generation backK192710 The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020
- This deviceK241983 Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −6 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −5 | K032687 | Ace Nancy Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| −4 | K081097 | Orthopediatrics Pediflex Flexible Nail System | Orthopediatrics, LLC | 2008 | — |
| −3 | K082375 | Orthopediatrics Pediflex Flexible Nail System | OrthoPediatrics Corp. | 2008 | — |
| −2 | K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | 2015 | 1 |
| −1 | K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | 2020 | — |
| 0 (this device) | K241983 | Fassier-Duval Telescoping IM System | Orthopediatrics Canada Ulc Dba Pega Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K211292 | Fassier-Duval Telescopic IM SystemSummary page 5…888.3020 Product Code(s) HSB I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211292 Fassier-Duval Telescopic IM System HSB K041393 Fassier-Duval Telescopic IM System HSB K020885 Fassier-Duval Telescopic IM System… | 2021 |
| * | K041393 | Fassier-Duval Telscopic IM SystemSummary page 5…ed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211292 Fassier-Duval Telescopic IM System HSB K041393 Fassier-Duval Telescopic IM System HSB K020885 Fassier-Duval Telescopic IM System HSB K192710 The Simple Locking Intramedullary (… | 2004 |
| * | K020885 | Fassire-Duval Telescopic IM SystemSummary page 5…ate # Predicate Trade Name (Primary Predicate is listed first) Product Code K211292 Fassier-Duval Telescopic IM System HSB K041393 Fassier-Duval Telescopic IM System HSB K020885 Fassier-Duval Telescopic IM System HSB K192710 The Simple Locking Intramedullary (Slim) System HSB Device Description Summary 21… | 2003 |
| * | K192710 | The Simple Locking Intramedullary (Slim) SystemSummary page 5…s listed first) Product Code K211292 Fassier-Duval Telescopic IM System HSB K041393 Fassier-Duval Telescopic IM System HSB K020885 Fassier-Duval Telescopic IM System HSB K192710 The Simple Locking Intramedullary (Slim) System HSB Device Description Summary 21 CFR 807.92(a)(4) The Fassier-Duval Telescopic… | 2020 |
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 29 years and passes through 7 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K211292.
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. 2025, 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 and other pediatric bone diseases 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/K241983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241983: Fassier-Duval Telescoping 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/K241983
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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