510(k) · Cleared
Recalled · Class II · 2015Fassire-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 Feb 6, 2003 as substantially equivalent to K980854 (Encore Orthopedics, Inc., 1998) and 2 other predicates after a 325-day review. Its family tree reaches back 2 generations to 1996. 15 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 6, 2003
- Review
- 325 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 2 generations to K960642 (1996). 4 ancestors in all, the oldest K813371 (1982). 15 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK960642 Nancy NailLandos, Inc. · 1996
- 1 generation backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- This deviceK020885 Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003
- Descendant · cites it directly · 14 of its ownK041393 Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 7 of its ownK111232 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · Recalled
- Descendant · cites it directly · 6 of its ownK160545 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 5 of its ownK192710 The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K041393Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · cites it directly14descendants
- K111232Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · cites it directly7descendants
- K160545Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016 · cites it directly6descendants
- K143355The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · 2 generations on6descendants
- K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −1 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| 0 (this device) | K020885 | Fassire-Duval Telescopic IM System | Pega Medical, Inc. | 2003 | — |
| +1 | K041393 | Fassier-Duval Telscopic IM System | Pega Medical, Inc. | 2004 | 5 |
| +1 | K111232 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2012 | 1 |
| +1 | K160545 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2016 | — |
| +2 | K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | 2015 | 1 |
| +3 | K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | 2020 | — |
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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K980854 | Retrograde Pediatric NailSummary page 2…ullary Nail, Zimmer, Inc. Warsaw, IN (510(k) number - Not available, pre-amendment device) 2. Retrograde Pediatric Nail, Encore Orthopedics, Inc., Austin, TX (K980854) 3. Intramdedullary Fixation Rod/Pin, Synthes (USA), Paoli, PA (K97 1783) 4. The Grosse & Kempf Intramedullary Nail, Howm… | 1998 |
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 2…pre-amendment device) 2. Retrograde Pediatric Nail, Encore Orthopedics, Inc., Austin, TX (K980854) 3. Intramdedullary Fixation Rod/Pin, Synthes (USA), Paoli, PA (K97 1783) 4. The Grosse & Kempf Intramedullary Nail, Howmedica, Rutherford, NJ (K8 13371) The intended uses of these devices a… | 1997 |
| * | K813371 | Grosse and Kempf Locking Nail Sys.Summary page 2…X (K980854) 3. Intramdedullary Fixation Rod/Pin, Synthes (USA), Paoli, PA (K97 1783) 4. The Grosse & Kempf Intramedullary Nail, Howmedica, Rutherford, NJ (K8 13371) The intended uses of these devices are the same as the Fassier-Duval Pediatric IM System. The technological characteristics of… | 1982 |
| * | — | Dubow-Bailey Intramedullary Nail Named without a submission number |
What descends from it? (15)
See all 155 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2015 | Class II | Z-1546-2015 | Nonconforming Material/Component | The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation… |
| Mar 5, 2014 | Class II | Z-1472-2014 | Error in labeling | The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. |
| Feb 7, 2014 | Class II | Z-1448-2014 | Nonconforming Material/Component | The Male Components in this lot are made of material with lower strength than manufacturing specifications. |
| Jan 29, 2010 | Not classified | Z-1494-2011 | Process control | Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K041393 (Pega Medical, Inc., 2004) has gone furthest, with 14 descendants of its own.
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.
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 lengtheninghhortening concomitantly with external fixators in pediatric or small stature patients with limb length discrepancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020885: Fassire-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/K020885
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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