510(k) · Cleared
ClearedThe Simple Locking Intramedullary (Slim) 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 Jun 24, 2020 as substantially equivalent to K143355 (Pega Medical, Inc., 2015) after a 271-day review. Its family tree reaches back 6 generations to 1996. 5 later devices descend from it.
- Decided
- Jun 24, 2020
- Review
- 271 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960642 (1996). 15 ancestors in all, the oldest K813371 (1982). 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK960642 Nancy NailLandos, Inc. · 1996
- 5 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 4 generations backK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
- 3 generations backK081097 Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC · 2008
- 2 generations backK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
- 1 generation backK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015 · Recalled
- This deviceK192710 The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK231266 Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023
- 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
- Descendant · cites it directly · 0 of its ownK250197 Estremo Fibular NailCitieffe S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK241983 Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical · 2025
Most influential descendants
Showing 5 of 5 · See all- K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023 · cites it directly2descendants
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 2 generations on1descendant
- K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · 3 generations on0descendants
- K250197Estremo Fibular NailCitieffe S.R.L. · 2025 · cites it directly0descendants
- K241983Fassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega Medical · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −5 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −4 | K032687 | Ace Nancy Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| −3 | K081097 | Orthopediatrics Pediflex Flexible Nail System | Orthopediatrics, LLC | 2008 | — |
| −2 | K082375 | Orthopediatrics Pediflex Flexible Nail System | OrthoPediatrics Corp. | 2008 | — |
| −1 | K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | 2015 | 1 |
| 0 (this device) | K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | 2020 | — |
| +1 | K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023 | — |
| +2 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
| +3 | K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026 | — |
| +1 | K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 2025 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K143355 | The Simple Locking IntraMedullary (SLIM) SystemSummary page 5…be substantially equivalent in design, indicated use and function to the following devices: Primary predicate: x The Simple Locking IntraMedullary (SLIM) System, K143355, Pega Medical Inc. References: x GAP Endo-Exo Medullary System, K160545, Pega Medical Inc. x Stainless Steel Elastic… | 2015 |
| † | K160545 | Gap Endo-Exo Medullary System | 2016 |
| † | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail System | 2008 |
What descends from it? (5)
3 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 24 years and passes through 6 companies; a new generation was cleared every 5.0 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K231266 (OrthoPediatrics Corp., 2023) 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. 2020, 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 Simple Locking IntraMedullary (SLIM) System is intended as a temporary implant for alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities, or have sustained fractures due to trauma or disease. This includes:
Femur and tibia in the pediatric population (child and adolescent), and small-stature adults such as patient with small intramedullary canals affected by skeletal dysplasias, osteogenesis imperfecta or other bone diseases.
Humerus, ulna, fibula in all patient populations
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/K192710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192710: The Simple Locking Intramedullary (Slim) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192710
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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