510(k) · Cleared

Recalled · Class II · 2012

Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series

K043270510(k) TraditionalCleared Jan 31, 200566-day reviewClass II21 CFR 888.3020Recalls 2

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

Zimmer GmbH · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jan 31, 2005 as substantially equivalent to K932330 (Synthes (Usa), 1996) and 5 other predicates after a 66-day review. Its family tree reaches back 1 generation to 1996. 53 later devices descend from it. It has been recalled 2 times.

Decided: Jan 31, 2005
Review: 66 days
Class: Class II
Product code: HSB
Recalls: 2
Predicates: 6

Its longest line of descent runs back 1 generation to K932330 (1996). 6 ancestors in all. 53 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK932330 TI-6AL-7NB UrtnSynthes (Usa) · 1996
This deviceK043270 Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631…Zimmer GmbH · 2005
Descendant · cites it directly · 39 of its ownK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
Descendant · cites it directly · 35 of its ownK082770 Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · Recalled
Descendant · 2 generations on · 17 of its ownK172774 T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System…Stryker Trauma GmbH · 2018
Descendant · 2 generations on · 16 of its ownK180436 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF…Stryker Trauma GmbH · 2018
Descendant · 2 generations on · 16 of its ownK091566 Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · Recalled

Showing 5 of 53 descendants. See all descendants

Descendants cleared per year

2008high 7 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 53 · See all

K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc. · 2009 · cites it directly39descendants
K082770Zimmer Natural Nail System Tibial NailZimmer, Inc. · 2008 · cites it directly35descendants
K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH · 2018 · 2 generations on17descendants
K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH · 2018 · 2 generations on16descendants
K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH · 2009 · 2 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932330	TI-6AL-7NB Urtn	Synthes (Usa)	1996	—
0 (this device)	K043270	Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651…	Zimmer GmbH	2005	—
+1	K083497	Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade…	Zimmer, Inc.	2009	16
+1	K082770	Zimmer Natural Nail System Tibial Nail	Zimmer, Inc.	2008	15
+2	K172774	T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN…	Stryker Trauma GmbH	2018	—
+2	K180436	T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…	Stryker Trauma GmbH	2018	—
+2	K091566	Zimmer Natural Nail System Cephalomedullary Nails	Zimmer GmbH	2009	5

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0
2002	2	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	3	0
2012	1	0
2013	1	0
2014	3	0
2017	4	0
2018	5	0
2019	4	0
2020	3	0
2021	1	0
2022	5	0
2023	5	0
2024	3	0
2025	7	0
2026	6	0

FIG. 1 — Lineage of K043270, 1996–2026Source: 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

Get a 510(k) Report

What was it cleared against? (6)

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
*	K932330	TI-6AL-7NB Urtn Summary page 1 …21 CFR § 888.3020 Predicate Devices: Unreamed Tibial Nail, manufactured by Synthes, K932330, cleared 03/08/1996 Lateral Entry Femoral Nail System by Synthes,…	Synthes (Usa)	1996	—
*	K040336	Synthes (Usa) Lateral Entry Femoral Nail System Summary page 1 …2330, cleared 03/08/1996 Lateral Entry Femoral Nail System by Synthes, K040336, cleared 04/12/2004 Osteo IC Retrograde/Antegrade Femoral Nail,…	Synthes (Usa)	2004	2
*	K982601	Osteo IC Retrograde/Antegrade Femoral Nail Summary page 1 …Osteo IC Retrograde/Antegrade Femoral Nail, manufactured by Osteonics, K982601, cleared 09/14/1998 T2 Femoral…	Osteonics Corp.	1998	—
*	K010801	T2 Femoral Nail Summary page 1 …9/14/1998 T2 Femoral Nail System, manufactured by Howmedica Osteonics, K0 10801, K014220, and K021744; cleared 04/06/200 1, 01/25/2002, and…	Howmedica Osteonics Corp.	2001	2
*	K014220	T2 Femoral Nail System Summary page 1 …T2 Femoral Nail System, manufactured by Howmedica Osteonics, K0 10801, K014220, and K021744; cleared 04/06/200 1, 01/25/2002, and…	Howmedica Osteonics Corp.	2002	—
*	K021744	T2 Femoral Nail Summary page 1 …ail System, manufactured by Howmedica Osteonics, K0 10801, K014220, and K021744; cleared 04/06/200 1, 01/25/2002, and 06/26/2002, respectively Device De…	Howmedica Osteonics Corp.	2002	—

Also cleared against K932330: 3 other devices →

What descends from it? (53)

See all 53

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

Number	Device	Applicant	Decided	Descendants
K083497	Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails	Zimmer, Inc.	2009	39
K082770	Zimmer Natural Nail System Tibial Nail	Zimmer, Inc.	2008	35
K080706	Connexx Locking Tibia Nail	I.T.S. Implantat-Technologie-Systeme GmbH	2008	11
K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail	I.T.S. GmbH	2014	10
K090596	Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…	Zimmer, Inc.	2009	3

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 4, 2012	Class II	Z-0247-2013	Error in labeling	Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product…
Mar 23, 2009	Not classified	Z-1261-2009	Other	The package is labeled as containing 330 mm length nails, but actually contains 300 mm length nails.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 6 ancestors have a recall of any class.
Of its descendants, K083497 (Zimmer, Inc., 2009) has gone furthest, with 39 descendants of its own.
3 other devices also cite its predicate K932330.

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?

Sirus intramedullary nail for femur with cap screw and corresponding locking screws

* All compound and simple femoral shaft fractures

* Sub-trochanteric fractures

* Pseudarthrosis and delayed union

Sirus intramedullary nail for femur in combination with the Sirus cervical screws

* Shaft fractures in combination with femoral neck fractures or peritrochanteric fractures

Sirus intramedullary nail for tibia with cap screw and corresponding locking screws

* Simple, compound first- and second-degree tibial shaft fractures

* Pseudarthrosis and delayed union

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043270 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043270: Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043270

Report an extraction error

Are you the manufacturer?

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