510(k) · Cleared

Cleared

True/Flex Humerus, Ulna & Radius Intramed Rods Sys

K913949510(k) TraditionalCleared Jan 17, 1992130-day reviewClass II21 CFR 888.3020

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

Applied Osteo Systems, Inc. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jan 17, 1992 after a 130-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 27 later devices descend from it.

Decided: Jan 17, 1992
Review: 130 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 0

27 later devices descend from it, 3 citing it directly.

This deviceK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
Descendant · cites it directly · 24 of its ownK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
Descendant · 2 generations on · 15 of its ownK071944 Acumed Small Bone Locking System IIAcumed, LLC · 2007
Descendant · 2 generations on · 10 of its ownK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
Descendant · 2 generations on · 10 of its ownK142945 Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015
Descendant · 2 generations on · 9 of its ownK160069 Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1996high 3 (2015) · low 0 (1997)2026

Most influential descendants

Showing 5 of 27 · See all

K031438Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · cites it directly24descendants
K071944Acumed Small Bone Locking System IIAcumed, LLC · 2007 · 2 generations on15descendants
K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015 · 2 generations on10descendants
K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015 · 2 generations on10descendants
K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K913949	True/Flex Humerus, Ulna & Radius Intramed Rods Sys	Applied Osteo Systems, Inc.	1992	—
+1	K031438	Acumed Small Bone Locking Rod System II	Acumed, LLC	2003	1
+2	K071944	Acumed Small Bone Locking System II	Acumed, LLC	2007	—
+2	K143276	Acumed Small Bone IM Nail System	Acumed, LLC	2015	—
+2	K142945	Sonoma Fibula Repair System	Sonoma Orthopedic Products, Inc.	2015	—
+2	K160069	Sonoma Fibula Repair System	Sonoma Orthopedics Products, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
2003	2	0
2007	2	0
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2015	3	0
2016	2	0
2017	3	0
2018	1	0
2021	2	0
2022	2	0
2024	1	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K913949, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HSB? 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 HSB device

#1 K200869 Gamma3 Systemscore 19.8 · 8 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K031438	Acumed Small Bone Locking Rod System II	Acumed, LLC	2003	24
K071679	Metafix and Fixion FA Intramedullary Nailing Systems	Disc-O-Tech Medical Technologies, Ltd.	2007	0
K964243	Humerus Wires	Compagnie Financiere & Medicale (Cf&M)	1996	0

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?

Of its descendants, K031438 (Acumed, LLC, 2003) has gone furthest, with 24 descendants of its own.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSB

15in 2025

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

https://510kreport.com/device/K913949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913949: True/Flex Humerus, Ulna & Radius Intramed Rods Sys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913949

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026