510(k) · Cleared

Cleared

LINK (TM) External Fixator

K240049510(k) TraditionalCleared May 29, 2024142-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

Metric Medical Devices, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on May 29, 2024 as substantially equivalent to K160972 (Gexfix International Corp., 2016) after a 142-day review. Its family tree reaches back 2 generations to 2005.

Decided: May 29, 2024
Review: 142 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K052605 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK052605 External FixationGexfix USA, Inc. · 2005
1 generation backK160972 Gexfix External FixationGexfix International Corp. · 2016
This deviceK240049 LINK (TM) External FixatorMetric Medical Devices, Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K052605	External Fixation	Gexfix USA, Inc.	2005	—
−1	K160972	Gexfix External Fixation	Gexfix International Corp.	2016	—
0 (this device)	K240049	LINK (TM) External Fixator	Metric Medical Devices, Inc.	2024	—

FIG. 1 — Lineage of K240049, 2005–2024Source: 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
*	K160972	Gexfix External Fixation Summary page 5 …ation, Nail/Blade/Plate Combination, Multiple Component Device classification: Class II per 21 CFR 888.3030 Product Code: KTT Predicate Device: Gexfix External Fixation (K160972, product code KTT) Reference Devices: ORTHOFIX MODULSYSTEM (K955848, product code JDW) and Super Staple™ Classic (K123363, produc…	Gexfix International Corp.	2016	—
†	K955848	Orthofix Modulsystem	Orthofix, Inc.	1996	23
†	K123363	Super Staple (TM) Classic	Metric Medical Devices, Inc.	2013	—

Also cleared against K160972: 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?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K160972.

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. 2024, 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 LINK™ External Fixator is indicated for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) adjunctive fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude LINK™ Bone Pin placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K240049 · printed Nov 6, 2026

Cite this page

510(k) Report. “K240049: LINK (TM) External Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240049

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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