510(k) · Cleared
Recalled · Class II · 2015Gap 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 Jan 26, 2012 as substantially equivalent to K041393 (Pega Medical, Inc., 2004) and 3 other predicates after a 269-day review. Its family tree reaches back 4 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Jan 26, 2012
- Review
- 269 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K960642 (1996). 9 ancestors in all, the oldest K813371 (1982). 7 later devices descend from it, 1 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 deviceK111232 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK160545 Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- Descendant · 2 generations on · 2 of its ownK231266 Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023
- Descendant · 3 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- Descendant · 3 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K160545Gap Endo-Exo Medullary SystemPega Medical, Inc. · 2016 · cites it directly6descendants
- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 2 generations on2descendants
- K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023 · 2 generations on2descendants
- K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 3 generations on1descendant
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 3 generations on1descendant
View 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) | K111232 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2012 | — |
| +1 | K160545 | Gap Endo-Exo Medullary System | Pega Medical, Inc. | 2016 | — |
| +2 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| +2 | K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023 | — |
| +3 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| +3 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K041393 | Fassier-Duval Telscopic IM SystemSummary page 2…t in design and function to the following predicate devices: 1. Fassier-Duval Telescopic IM System (Stainless steel or Ti pediatric nail), Pega Medical Inc. (K041393/K020885) 2. Synthes Adolescent Lateral Entry Femoral Nail System (Ti alloy nail and screws), Synthes USA. (K070843)… | 2004 |
| * | K020885 | Fassire-Duval Telescopic IM SystemSummary page 2…ign and function to the following predicate devices: 1. Fassier-Duval Telescopic IM System (Stainless steel or Ti pediatric nail), Pega Medical Inc. (K041393/K020885) 2. Synthes Adolescent Lateral Entry Femoral Nail System (Ti alloy nail and screws), Synthes USA. (K070843) 3. Tit… | 2003 |
| * | K070843 | Synthes Adolescent Lateral Entry Femoral Nail SystemSummary page 2…pediatric nail), Pega Medical Inc. (K041393/K020885) 2. Synthes Adolescent Lateral Entry Femoral Nail System (Ti alloy nail and screws), Synthes USA. (K070843) 3. Titanium Pediatric Femoral Nail (Ti alloy nail and screws) Biomet Inc. (K993956) The intended uses of these devi… | 2007 |
| * | K993956 | Titanium Pediatric Femoral NailSummary page 2…ry Femoral Nail System (Ti alloy nail and screws), Synthes USA. (K070843) 3. Titanium Pediatric Femoral Nail (Ti alloy nail and screws) Biomet Inc. (K993956) The intended uses of these devices are the same as the GAP Endlo-Exo Medullary System Summary of Technologies: The technologic… | 1999 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160545 | Gap Endo-Exo Medullary System | 2016 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2015 | Class II | Z-1362-2015 | Other | Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI).… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K160545 (Pega Medical, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K041393.
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. 2012, 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 Endlo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions:
* Diaphyseal facture of the femur, tibia and humerus
* Fractures of the femoral neck
* Subtrochanteric, intertrochanteric and combination fractures
* Correction of deformities (01, Coxa vara, Coxa valga)>
" Nonunions and malunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111232: Gap Endo-Exo Medullary System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111232
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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