510(k) · Cleared

Cleared

Numelock II System

K041709510(k) TraditionalCleared Sep 8, 200477-day reviewClass II21 CFR 888.3030

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

Howmedica Osteonics Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Sep 8, 2004 after a 77-day review. The FDA summary names no predicate by number. 1 of the 590 devices in its family, counting itself, has a Class I recall. 589 later devices descend from it.

Decided: Sep 8, 2004
Review: 77 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

589 later devices descend from it, 3 citing it directly. 1 of the 590 devices in this family, counting this one, has a Class I recall.

This deviceK041709 Numelock II SystemHowmedica Osteonics Corp. · 2004
Descendant · cites it directly · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
Descendant · 2 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
Descendant · 3 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
Descendant · 4 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011

Showing 5 of 589 descendants. See all descendants

Descendants cleared per year

2005high 71 (2026) · low 1 (2005)2026

Class I recalls in this family

K211616 ExcelsiusHub7 generations on · 2021

Most influential descendants

Showing 5 of 589 · See all

K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · cites it directly584descendants
K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 2 generations on495descendants
K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 3 generations on487descendants
K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants
K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 4 generations on161descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K041709	Numelock II System	Howmedica Osteonics Corp.	2004	—
+1	K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	—
+2	K071563	Peri-Loc Periarticular Locked Plating System	Smith & Nephew, Inc.	2007	—
+3	K090675	Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories	Smith & Nephew, Inc.	2009	—
+4	K100776	Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System	Synthes (Usa)	2010	—
+4	K111994	Smith & Nephew Cannulated Screws and Washers	Smith & Nephew, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	5	0
2007	1	0
2008	2	0
2009	5	0
2010	9	0
2011	10	0
2012	15	0
2013	11	0
2014	27	0
2015	30	0
2016	23	0
2017	44	0
2018	25	0
2019	32	0
2020	39	0
2021	46	1
2022	35	0
2023	44	0
2024	60	0
2025	54	0
2026	71	0

FIG. 1 — Lineage of K041709, 2004–2026Source: 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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (589)

See all 589

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

Number	Device	Applicant	Decided	Descendants
K051735	Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity	Smith & Nephew, Inc.	2005	584
K100604	Otis -C Plus	Sciences ET Bio Materiaux (Sbm)	2010	2
K060545	Unity Humeral Plate	Tornier	2006	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K051735 (Smith & Nephew, Inc., 2005) has gone furthest, with 584 descendants of its own.

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 Numelock II System is intended for use in the temporary stabilization of long bone fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041709 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041709: Numelock II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041709

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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