510(k) · Cleared
ClearedModification to Slim Gliding Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Dec 18, 2003 as substantially equivalent to K020240 (Plus Orthopedics, 2002) after a 16-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Dec 18, 2003
- Review
- 16 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974409 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK974409 Friedl Gliding Nail SystemPlus Orthopedics · 1998
- 1 generation backK020240 Slim Gliding Nail SystemPlus Orthopedics · 2002 · Recalled
- This deviceK033763 Modification to Slim Gliding Nail SystemPlus Orthopedics · 2003
- Descendant · cites it directly · 0 of its ownK122170 Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974409 | Friedl Gliding Nail System | Plus Orthopedics | 1998 | — |
| −1 | K020240 | Slim Gliding Nail System | Plus Orthopedics | 2002 | 1 |
| 0 (this device) | K033763 | Modification to Slim Gliding Nail System | Plus Orthopedics | 2003 | — |
| +1 | K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | Smith & Nephew, Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 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 |
|---|---|---|---|
| * | K020240 | Slim Gliding Nail SystemSummary page 1…Number 21 CFR 888.3030 Product Code: KTT Original Predicate Device: SLIM Gliding Nail System, K020240 The indications for use have not changed… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | 2012 | 0 |
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 5 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122170 (Smith & Nephew, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020240.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in: * Pertrochanteric femoral fractures * Subtrochanteric femoral fractures and * Lateral femoral neck fractures Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding…
Read the full statement (116 words)
The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring
primary load stability in:
* Pertrochanteric femoral fractures
* Subtrochanteric femoral fractures and
* Lateral femoral neck fractures
Internal fixation with the SLIM Gliding Nail System is indicated in all combination
injuries involving the lateral femoral neck or trochanter region and femoral shaft
fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is
also suitable for medical femoral neck fractures with retention of the head and simple
femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be
used to secure pathological fractures or to provide weight-bearing stability after varus and
valgus revision osteotomies of the proximal femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033763: Modification to Slim Gliding Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033763
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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