510(k) · Cleared

Recalled · 2009

Biomet Femoral Locking Nail System

K072161510(k) TraditionalCleared Sep 20, 200745-day reviewClass II21 CFR 888.3020Recalls 8

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

Biomet Manufacturing Corp · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 20, 2007 as substantially equivalent to K983641 (Biomet, Inc., 1998) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1998. 22 later devices descend from it. It has been recalled 8 times.

Decided: Sep 20, 2007
Review: 45 days
Class: Class II
Product code: HSB
Recalls: 8
Predicates: 3

Its longest line of descent runs back 1 generation to K982953 (1998). 3 ancestors in all. 22 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
This deviceK072161 Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp · 2007
Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
Descendant · cites it directly · 6 of its ownK083726 Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · Recalled
Descendant · 2 generations on · 4 of its ownK172583 OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · Recalled
Descendant · 2 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
Descendant · cites it directly · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2009high 4 (2026) · low 0 (2010)2026

Most influential descendants

Showing 5 of 22 · See all

K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp. · 2009 · cites it directly6descendants
K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018 · 2 generations on4descendants
K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 2 generations on3descendants
K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982953	Titanium Intramedullary Nails-Various Styles	Biomet, Inc.	1998	4
0 (this device)	K072161	Biomet Femoral Locking Nail System	Biomet Manufacturing Corp	2007	—
+1	K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…	I.T.S. GmbH	2014	—
+1	K083726	Pedinail Intramedullary Nailing System	OrthoPediatrics Corp.	2009	27
+2	K172583	OrthoPediatrics PediNail Intramedullary Platform	Orthopediatrics, Inc.	2018	3
+2	K161327	Syntec Humeral Nail System	Syntec Scientific Corporation	2017	—
+1	K241651	Affixus Tibial and Antegrade Femoral Nailing System	Zimmer, Inc.	2024	17

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2014	2	0
2017	2	0
2018	2	0
2019	3	0
2020	1	0
2022	1	0
2023	1	0
2024	1	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K072161, 1998–2026Source: 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? (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
*	K983641	Holland Femoral Nail System Summary page 1 …fication Name: Rod, Fixation, Intramedullary and Accessories (CFR 888.3020) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K983641, Holland Nail TM System (Biomet); K982953, Uniflex® Nailing System (Biomet); and K023267, T2 M…	Biomet, Inc.	1998	—
*	K982953	Titanium Intramedullary Nails-Various Styles Summary page 1 …ssories (CFR 888.3020) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K983641, Holland Nail TM System (Biomet); K982953, Uniflex® Nailing System (Biomet); and K023267, T2 M…	Biomet, Inc.	1998	4
*	K023267	T2 Supracondylar Nail System Summary page 1 …s To Which Substantial Equivalence Is Claimed: K983641, Holland Nail TM System (Biomet); K982953, Uniflex® Nailing System (Biomet); and K023267, T2 M T…	Howmedica Osteonics Corp.	2002	1

Also cleared against K983641: 2 other devices →

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail	I.T.S. GmbH	2014	10
K083726	Pedinail Intramedullary Nailing System	OrthoPediatrics Corp.	2009	6
K241651	Affixus Tibial and Antegrade Femoral Nailing System	Zimmer, Inc.	2024	2
K253566	Affixus Retrograde Femoral Nailing System	Zimmer, Inc.	2026	0
K081230	Trauson Intramedullary Nail	Trauson (Jiangsu) Medical Instrument Co., Ltd.	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 2, 2009	Not classified	Z-2283-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2279-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2278-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2277-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2281-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2280-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Apr 2, 2009	Not classified	Z-2282-2009	Nonconforming Material/Component	Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
Mar 27, 2009	Not classified	Z-2115-2009	Nonconforming Material/Component	Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.

The 5 latest of 8 recalls; the web page lists all.

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.
Of its descendants, K132945 (I.T.S. GmbH, 2014) has gone furthest, with 10 descendants of its own.
2 other devices also cite its predicate K983641.

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. 2007, this device’s year, is highlighted.

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?

These devices are to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072161 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072161: Biomet Femoral Locking Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072161

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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