510(k) · Cleared
Recalled · Class II · 2019The 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 Jul 10, 2015 as substantially equivalent to K081452 (Synthes (Usa), 2008) and 2 other predicates after a 228-day review. Its family tree reaches back 5 generations to 1996. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2015
- Review
- 228 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960642 (1996). 14 ancestors in all, the oldest K813371 (1982). 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK960642 Nancy NailLandos, Inc. · 1996
- 4 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 3 generations backK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
- 2 generations backK081097 Orthopediatrics Pediflex Flexible Nail SystemOrthopediatrics, LLC · 2008
- 1 generation backK082375 Orthopediatrics Pediflex Flexible Nail SystemOrthoPediatrics Corp. · 2008
- This deviceK143355 The Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK192710 The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK231266 Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023
- Descendant · 3 generations on · 1 of its ownK250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025
- Descendant · 4 generations on · 0 of its ownK261345 Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
- Descendant · 2 generations on · 0 of its ownK250197 Estremo Fibular NailCitieffe S.R.L. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192710The Simple Locking Intramedullary (Slim) SystemPega Medical, Inc. · 2020 · cites it directly5descendants
- K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp. · 2023 · 2 generations on2descendants
- K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2025 · 3 generations on1descendant
- K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026 · 4 generations on0descendants
- K250197Estremo Fibular NailCitieffe S.R.L. · 2025 · 2 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 | K032687 | Ace Nancy Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K081097 | Orthopediatrics Pediflex Flexible Nail System | Orthopediatrics, LLC | 2008 | — |
| −1 | K082375 | Orthopediatrics Pediflex Flexible Nail System | OrthoPediatrics Corp. | 2008 | — |
| 0 (this device) | K143355 | The Simple Locking IntraMedullary (SLIM) System | Pega Medical, Inc. | 2015 | — |
| +1 | K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | 2020 | — |
| +2 | K231266 | Pediatric Nailing Platform Tibia | OrthoPediatrics Corp. | 2023 | — |
| +3 | K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2025 | — |
| +4 | K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | 2026 | — |
| +2 | K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSummary page 4…med to be substantially equivalent in design, indicated use and function to the following predicate devices: 1. Stainless Steel Elastic Intramedullary Nail System [K081452] Synthes (Usa) 2. Pediflex Flexible Nail System [K082375] Orthopediatrics 3. Fassier-Duval Telescopic IM System [K041393]… | 2008 |
| * | K082375 | Orthopediatrics Pediflex Flexible Nail SystemSummary page 4…nd function to the following predicate devices: 1. Stainless Steel Elastic Intramedullary Nail System [K081452] Synthes (Usa) 2. Pediflex Flexible Nail System [K082375] Orthopediatrics 3. Fassier-Duval Telescopic IM System [K041393] Pega Medical Inc.… | 2008 |
| * | K041393 | Fassier-Duval Telscopic IM SystemSummary page 4…teel Elastic Intramedullary Nail System [K081452] Synthes (Usa) 2. Pediflex Flexible Nail System [K082375] Orthopediatrics 3. Fassier-Duval Telescopic IM System [K041393] Pega Medical Inc. K143355 Page… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192710 | The Simple Locking Intramedullary (Slim) System | 2020 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2019 | Class II | Z-2278-2019 | Component design/selection | Handle could jam with the Driver due to the detachment of an internal Connector Ring. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K192710 (Pega Medical, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K081452.
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. 2015, 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 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 the femur, tibia, humerus, ulna and fibula of the pediatric population (child and adolescent), and patients with small intramedullary canals affected by skeletal displasias, osteogenesis imperfecta or other bone diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143355: 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/K143355
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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