510(k) · Cleared

Recalled · 2008

Acumed Small Bone Locking Rod System II

K031438510(k) TraditionalCleared Jul 17, 200372-day reviewClass II21 CFR 888.3020Recalls 1

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

Acumed, LLC · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jul 17, 2003 as substantially equivalent to K951673 (Acu Med, Inc., 1995) and 2 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1992. 24 later devices descend from it. It has been recalled once.

Decided: Jul 17, 2003
Review: 72 days
Class: Class II
Product code: HSB
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K913949 (1992). 3 ancestors in all. 24 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
This deviceK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003
Descendant · cites it directly · 15 of its ownK071944 Acumed Small Bone Locking System IIAcumed, LLC · 2007
Descendant · cites it directly · 10 of its ownK143276 Acumed Small Bone IM Nail SystemAcumed, LLC · 2015
Descendant · cites it directly · 10 of its ownK142945 Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015
Descendant · cites it directly · 9 of its ownK160069 Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016
Descendant · cites it directly · 5 of its ownK032548 IP-XS Compression Nail SystemPlus Orthopedics · 2003

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2003high 3 (2015) · low 0 (2004)2026

Most influential descendants

Showing 5 of 24 · See all

K071944Acumed Small Bone Locking System IIAcumed, LLC · 2007 · cites it directly15descendants
K143276Acumed Small Bone IM Nail SystemAcumed, LLC · 2015 · cites it directly10descendants
K142945Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015 · cites it directly10descendants
K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016 · cites it directly9descendants
K032548IP-XS Compression Nail SystemPlus Orthopedics · 2003 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913949	True/Flex Humerus, Ulna & Radius Intramed Rods Sys	Applied Osteo Systems, Inc.	1992	—
0 (this device)	K031438	Acumed Small Bone Locking Rod System II	Acumed, LLC	2003	—
+1	K071944	Acumed Small Bone Locking System II	Acumed, LLC	2007	—
+1	K143276	Acumed Small Bone IM Nail System	Acumed, LLC	2015	—
+1	K142945	Sonoma Fibula Repair System	Sonoma Orthopedic Products, Inc.	2015	—
+1	K160069	Sonoma Fibula Repair System	Sonoma Orthopedics Products, Inc.	2016	—
+1	K032548	IP-XS Compression Nail System	Plus Orthopedics	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2007	1	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 K031438, 1992–2026Source: 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.

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? (4)

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
*	K951673	Rod, Fixation, Intramedullary and Accessories Summary page 1 …Class II,21 CFR 888.3020 Device Product Code: HSB Legally Marketed Equivalent Device(s): Acumed Small Bone Locking Rod System K95 1673 Biomet Inc. Titanium Intramedullary Rods Various Sizes K982953…	Acu Med, Inc.	1995	—
*	K982953	Titanium Intramedullary Nails-Various Styles Summary page 1 …uivalent Device(s): Acumed Small Bone Locking Rod System K95 1673 Biomet Inc. Titanium Intramedullary Rods Various Sizes K982953 Biomet Inc. S.S.T. Small Bone Locking Nail K# unknown…	Biomet, Inc.	1998	4
*	K913949	True/Flex Humerus, Ulna & Radius Intramed Rods Sys Summary page 1 …Biomet Inc. S.S.T. Small Bone Locking Nail K# unknown Encore Orthopedics Inc. TrueElex Intramedullary Rod K913949 Device Description: The Acumed Small Bone Locking Rod I1 is an intramedullary rod with solid and cannulated versions. Rods are m…	Applied Osteo Systems, Inc.	1992	—
*	—	Biomet Inc. S.S.T. Small Bone Locking Nail Named without a submission number			—

Also cleared against K951673: 1 other device →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K071944	Acumed Small Bone Locking System II	Acumed, LLC	2007	15
K143276	Acumed Small Bone IM Nail System	Acumed, LLC	2015	10
K142945	Sonoma Fibula Repair System	Sonoma Orthopedic Products, Inc.	2015	10
K160069	Sonoma Fibula Repair System	Sonoma Orthopedics Products, Inc.	2016	9
K032548	IP-XS Compression Nail System	Plus Orthopedics	2003	5
K172943	Flex-Thread Fibula Pin System	Intrafuse, LLC	2017	4
K163014	AOS Small Bone Nailing System	Advanced Orthopaedic Solutions, Inc. (Aos)	2017	1
K252961	Fusion FibFix Nail	Fusion Orthopedics USA, LLC	2026	0
K151456	Small Bone Nail Implant	Vilex IN Tennessee, Inc.	2015	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2008	Not classified	Z-1552-2010	Other	Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material.

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.
Of its descendants, K071944 (Acumed, LLC, 2007) has gone furthest, with 15 descendants of its own.
1 other device also cites its predicate K951673.

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	—

What is it indicated for?

The Acurned Small Bone Locking System I I and accessories are designed specifically for fractures and osteotomies of the fibula, radius, and ulna.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031438 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031438: Acumed Small Bone Locking Rod System II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031438

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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