510(k) · Cleared

Recalled · 2003

Slim Gliding Nail System

K020240510(k) SpecialCleared Feb 22, 200230-day reviewClass II21 CFR 888.3030Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Plus Orthopedics · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Feb 22, 2002 as substantially equivalent to K974409 (Plus Orthopedics, 1998) after a 30-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it. It has been recalled once.

Decided: Feb 22, 2002
Review: 30 days
Class: Class II
Product code: KTT
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K974409 (1998). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK974409 Friedl Gliding Nail SystemPlus Orthopedics · 1998
This deviceK020240 Slim Gliding Nail SystemPlus Orthopedics · 2002
Descendant · cites it directly · 1 of its ownK033763 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 2 of 2 · See all

K033763Modification to Slim Gliding Nail SystemPlus Orthopedics · 2003 · cites it directly1descendant
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
−1	K974409	Friedl Gliding Nail System	Plus Orthopedics	1998	—
0 (this device)	K020240	Slim Gliding Nail System	Plus Orthopedics	2002	—
+1	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
2003	1	0
2012	1	0

FIG. 1 — Lineage of K020240, 1998–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K974409	Friedl Gliding Nail System Summary page 1 …Nail/Bl;ade/Plate Combination, Multiple Component name: § 888.3030, Class I, Product Code: KTT, 87 Orthopedic Device Panel Predicate Device: FRIEDL Gliding Nail System, K974409 — S/E 2/19/1998 We added the following smaller nails to our predicate device (FRIEDL Device Madification Gliding Nail System,…	Plus Orthopedics	1998	—

Also cleared against K974409: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033763	Modification to Slim Gliding Nail System	Plus Orthopedics	2003	1
K122170	Smith & Nephew, Inc. Intramedullary Nail System Instrumentation	Smith & Nephew, Inc.	2012	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 30, 2003	Not classified	Z-0360-2008	Reprocessing Controls	The device was produced without the required distal locking hole

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K033763 (Plus Orthopedics, 2003) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K974409.

How does its category compare?

All KTT devices

KTT 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

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)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 medial 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020240: 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/K020240

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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