510(k) · Cleared

Cleared

External Fixation Ring

K022423510(k) TraditionalCleared Sep 17, 200255-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

Rigid FX Orthopedics, Incorporated · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Sep 17, 2002 as substantially equivalent to K000957 (Howmedica Osteonics Corp., 2000) and 2 other predicates after a 55-day review. Its family tree reaches back 1 generation to 1994.

Decided: Sep 17, 2002
Review: 55 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K941048 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK941048 True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 1994 · Recalled
This deviceK022423 External Fixation RingRigid FX Orthopedics, Incorporated · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941048	True/Lok Monolateral/Bilateral Fixator	Applied Osteo Systems, Inc.	1994	1
0 (this device)	K022423	External Fixation Ring	Rigid FX Orthopedics, Incorporated	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2000	1	0

FIG. 1 — Lineage of K022423, 1994–2002Source: 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? (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
*	K000957	Hoffmann II External Fixation System	Howmedica Osteonics Corp.	2000	—
*	K941048	True/Lok Monolateral/Bilateral Fixator Summary page 1 …o receive various pin clamps and distractors Encore Medical, L.P.1 K941048 Smith & Nephew/K970748 Device Description This device is the ring component of an external fixation de…	Applied Osteo Systems, Inc.	1994	1
*	K970748	Taylor Spatial Frame External Fixation System Summary page 1 …distractors Encore Medical, L.P.1 K941048 Smith & Nephew/K970748 Device Description This device is the ring component of an external fixation device. Pin/wire clamps and distractors are attac…	Smith & Nephew, Inc., Orthopaedic Div.	1997	—

Also cleared against K000957: 1 other device →

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?

1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K000957.

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?

When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022423 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022423: External Fixation Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022423

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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