510(k) · Cleared

Cleared

Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)

K091619510(k) TraditionalCleared Sep 8, 200997-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

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

Cleared on Sep 8, 2009 as substantially equivalent to K060613 (Howmedica Osteonics Corp., 2006) and 2 other predicates after a 97-day review. Its family tree reaches back 1 generation to 2004.

Decided: Sep 8, 2009
Review: 97 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K033995 (2004). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK033995 3.5 MM LCP Distal Humerus SystemSynthes (Usa) · 2004 · Recalled
This deviceK091619 Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)Anglefix · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033995	3.5 MM LCP Distal Humerus System	Synthes (Usa)	2004	1
0 (this device)	K091619	Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw)	Anglefix	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0

FIG. 1 — Lineage of K091619, 2004–2009Source: 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 21.4 · 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? (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	Applicant	Decided	Recalls
*	K060613	Variax Locking Plate System	Howmedica Osteonics Corp.	2006	—
*	K033995	3.5 MM LCP Distal Humerus System Summary page 1 …screws. Predicate Device(s): Howmedica VariAx Locking plate System (KO606 13), the Synthes 3.5mm LCP Distal Humerus System (K033995) and the Synthes AxSOS Plus Locking Plate System (KO61012). Performance Testing: Th…	Synthes (Usa)	2004	1
*	K061012	Axsos Plus Locking Plate System	Howmedica Osteonics Corp.	2006	2

Also cleared against K060613: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

2 of the 3 ancestors have a recall of any class.
3 other devices also cite its predicate K060613.

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. 2009, this device’s year, is highlighted.

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 AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:

* Proximal and distal fractures including joint fractures of the humerus, tibia and other long bones

* Metaphyseal, supracondylar, peri-articular, intra-articular,. and intra-articular condylar fractures

* Diaphyseal fractures

* Ankle fractures

* Simple, comminuted and depression fractures

* Non-unions and malunions

* Osteotomies and bone reconstruction

* Fractures in normal or osteoporotic bone

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091619 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091619: Anglefix T Locking Plate, Models AF-001 (Plate), ST-1 (Locking Screw).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091619

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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