510(k) · Cleared
ClearedGap Endo-Exo Medullary 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 Nov 23, 2016 as substantially equivalent to K111232 (Pega Medical, Inc., 2012) and 2 other predicates after a 271-day review. Its family tree reaches back 5 generations to 1996. 6 later devices descend from it.
- Decided
- Nov 23, 2016
- Review
- 271 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960642 (1996). 10 ancestors in all, the oldest K813371 (1982). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK960642 Nancy NailLandos, Inc. · 1996
- 4 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 3 generations backK020885 Fassire-Duval Telescopic IM SystemPega Medical, Inc. · 2003 · Recalled
- 2 generations backK041393 Fassier-Duval Telscopic IM SystemPega Medical, Inc. · 2004 · Recalled
- 1 generation backK111232 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012 · Recalled
- This deviceK160545 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- Descendant · cites it directly · 2 of its ownK231266 Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023
- Descendant · 2 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- Descendant · 2 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
- Descendant · 3 generations on · 0 of its ownK261345 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · cites it directly2descendants
- K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023 · cites it directly2descendants
- K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 2 generations on1descendant
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 2 generations on1descendant
- K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −4 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −3 | K020885 | Fassire-Duval Telescopic IM System | Pega Medical, Inc. | 2003 | 4 |
| −2 | K041393 | Fassier-Duval Telscopic IM System | Pega Medical, Inc. | 2004 | 5 |
| −1 | K111232 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2012 | 1 |
| 0 (this device) | K160545 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2016 | — |
| +1 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| +1 | K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023 | — |
| +2 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| +2 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
| +3 | K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K111232 | Gap Endo-Exo Medullary SystemSummary page 4…tem is claimed to be substantially equivalent in design and function to the following predicate devices: 1. The GAP Endo-Exo Medullary System, Pega Medical Inc. [K111232] 2. The Fassier-Duval Telescopic IM System (Stainless steel or Ti pediatric Nail), Pega Medical Inc. [K041393… | 2012 |
| * | K041393 | Fassier-Duval Telscopic IM SystemSummary page 4…xo Medullary System, Pega Medical Inc. [K111232] 2. The Fassier-Duval Telescopic IM System (Stainless steel or Ti pediatric Nail), Pega Medical Inc. [K041393/K020885] K160545 Pa… | 2004 |
| * | K020885 | Fassire-Duval Telescopic IM SystemSummary page 4…lary System, Pega Medical Inc. [K111232] 2. The Fassier-Duval Telescopic IM System (Stainless steel or Ti pediatric Nail), Pega Medical Inc. [K041393/K020885] K160545 Page 2 of… | 2003 |
What descends from it? (6)
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 20 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K250163 (Stryker GmbH, 2025) has gone furthest, with 2 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. 2016, 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?
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions:
* Diaphyseal fracture of the femur, tibia and humerus
* Fractures of the femoral neck
* Subtrochanteric, intertrochanteric and combination fractures
* Correction of deformities (OI, Coxa vara, Coxa valga)
* Nonunions and malunions
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/K160545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160545: Gap Endo-Exo Medullary System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160545
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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