510(k) · Cleared

Cleared

CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail

K132945510(k) TraditionalCleared Mar 7, 2014169-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

I.T.S. GmbH · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 7, 2014 as substantially equivalent to K970097 (Synthes (Usa), 1997) and 20 other predicates after a 169-day review. Its family tree reaches back 5 generations to 2000. 10 later devices descend from it.

Decided: Mar 7, 2014
Review: 169 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 21

Its longest line of descent runs back 5 generations to K000684 (2000). 70 ancestors in all, the oldest K890939 (1989). 10 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
4 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
3 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
2 generations backK063460 Acumed Congruent Bone Plate SystemAcumed, LLC · 2006
1 generation backK080184 Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · Recalled
This deviceK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
Descendant · cites it directly · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
Descendant · 2 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
Descendant · cites it directly · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK230257 Arthrex Intramedullary NailsArthrex, Inc. · 2023
Descendant · cites it directly · 1 of its ownK170972 Apex Tibial Nailing SystemOrthoxel · 2017

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2014high 2 (2017) · low 0 (2015)2026

Most influential descendants

Showing 5 of 10 · See all

K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · cites it directly3descendants
K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 2 generations on2descendants
K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · cites it directly2descendants
K230257Arthrex Intramedullary NailsArthrex, Inc. · 2023 · 2 generations on1descendant
K170972Apex Tibial Nailing SystemOrthoxel · 2017 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−4	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
−3	K012655	Congruent Bone Plate System	Acu Med, Inc.	2001	16
−2	K063460	Acumed Congruent Bone Plate System	Acumed, LLC	2006	—
−1	K080184	Distal Humeral Plates with Angular Stability	I.T.S. Implantat-Technologie-Systeme GmbH	2008	1
0 (this device)	K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…	I.T.S. GmbH	2014	—
+1	K161327	Syntec Humeral Nail System	Syntec Scientific Corporation	2017	—
+2	K181296	Syntec Femoral Nail System	Syntec Scientific Corporation	2019	—
+1	K141228	Aos 6.5MM Captured, Fully Threaded Cancellous Screw	Advanced Orthopaedic Solutions, Inc.	2014	—
+2	K230257	Arthrex Intramedullary Nails	Arthrex, Inc.	2023	—
+1	K170972	Apex Tibial Nailing System	Orthoxel	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1992	3	0
1995	3	0
1996	6	0
1997	3	0
1998	6	0
1999	1	0
2000	4	0
2001	7	0
2002	4	0
2003	6	0
2004	8	0
2005	2	0
2007	3	0
2008	2	0
2009	2	0
2010	1	0
2011	1	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2017	2	0
2019	2	0
2020	1	0
2023	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K132945, 2000–2026Source: 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? (21)

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
*	K970097	Proximal Femoral Nail (PFN) System Summary page 1 …HWC, LIDS, KTT SUBSTANTIALLY EQUIVALENT DEVICES Synthes - Proximal Femoral (PFN) & Cannulated Femoral Nail (CFN) Systems (K970097, K(954856) Zimmer - Sirus IM Femur Nail System (K(093270) Stryker - T2 REC…	Synthes (Usa)	1997	—
*	K954856	Cannulated Femoral Nail Summary page 1 …HWC, LIDS, KTT SUBSTANTIALLY EQUIVALENT DEVICES Synthes - Proximal Femoral (PFN) & Cannulated Femoral Nail (CFN) Systems (K970097, K(954856) Zimmer - Sirus IM Femur Nail System (K(093270) Stryker - T2 RECON Nail Sy…	Synthes (Usa)	1996	—
*	K043270	Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652… Our reading of the summary gave K093270, FDA’s number for Powder-Free Vinyl Patient Examination Gloves (Tangshan Excellence Glove Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer - Sirus IM Femur Nail System”.	Zimmer GmbH	2005	2
*	K032898	T2 Recon Nail System Summary page 1 …Systems (K970097, K(954856) Zimmer - Sirus IM Femur Nail System (K(093270) Stryker - T2 RECON Nail System (K(032898, K(051624, K(102992) Biomet - Femoral Locking Nail System (K(072161) Synt…	Howmedica Osteonics Corp.	2003	1
*	K051624	T2 Recon Nail System Summary page 1 …ems (K970097, K(954856) Zimmer - Sirus IM Femur Nail System (K(093270) Stryker - T2 RECON Nail System (K(032898, K(051624, K(102992) Biomet - Femoral Locking Nail System (K(072161) Synthes - Ti C…	Howmedica Osteonics Corp.	2005	—
*	K102992	T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees Summary page 1 …97, K(954856) Zimmer - Sirus IM Femur Nail System (K(093270) Stryker - T2 RECON Nail System (K(032898, K(051624, K(102992) Biomet - Femoral Locking Nail System (K(072161) Synthes - Ti Cannulated…	Howmedica Osteonics Corp.	2010	—
*	K072161	Biomet Femoral Locking Nail System Summary page 1 …(K(093270) Stryker - T2 RECON Nail System (K(032898, K(051624, K(102992) Biomet - Femoral Locking Nail System (K(072161) Synthes - Ti Cannulated Tibial Nail (CTN) System (K(962047) 'Zimmer - Sir…	Biomet Manufacturing Corp	2007	8
*	K962047	Titanium Cannulated Tibial Nail (TI CTN) Summary page 1 …24, K(102992) Biomet - Femoral Locking Nail System (K(072161) Synthes - Ti Cannulated Tibial Nail (CTN) System (K(962047) 'Zimmer - Sirus IM Tibia Nail System (1(093270, K(082770) Stryker - T2 Ti…	Synthes (Usa)	1996	—
*	K082770	Zimmer Natural Nail System Tibial Nail Summary page 1 …161) Synthes - Ti Cannulated Tibial Nail (CTN) System (K(962047) 'Zimmer - Sirus IM Tibia Nail System (1(093270, K(082770) Stryker - T2 Tibial Nailing System (K(021027,1(01 1622,K003018) Biomet -…	Zimmer, Inc.	2008	15
*	K021027	S2 Tibial Nail Summary page 1 …System (K(962047) 'Zimmer - Sirus IM Tibia Nail System (1(093270, K(082770) Stryker - T2 Tibial Nailing System (K(021027,1(01 1622,K003018) Biomet - Tibial Locking Nail System (K(063570) l.T.S.…	Howmedica Osteonics Corp.	2002	—
*	K011622	Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2…	Howmedica Osteonics Corp.	2001	—
*	K003018	Titan Tibial Nail Summary page 1 …) 'Zimmer - Sirus IM Tibia Nail System (1(093270, K(082770) Stryker - T2 Tibial Nailing System (K(021027,1(01 1622,K003018) Biomet - Tibial Locking Nail System (K(063570) l.T.S. - CONNEXX Locking…	Howmedica Osteonics Corp.	2000	22
*	K063570	Biomet Tibial Locking Nail System Summary page 1 …K(082770) Stryker - T2 Tibial Nailing System (K(021027,1(01 1622,K003018) Biomet - Tibial Locking Nail System (K(063570) l.T.S. - CONNEXX Locking Tibia Nail (1(080706) I.T.S. IMI Nail Systems CFN-CTN-CHN…	Biomet Manufacturing Corp	2007	3
*	K080706	Connexx Locking Tibia Nail Summary page 1 …K(021027,1(01 1622,K003018) Biomet - Tibial Locking Nail System (K(063570) l.T.S. - CONNEXX Locking Tibia Nail (1(080706) I.T.S. IMI Nail Systems CFN-CTN-CHN Page 1 of 4 Section XII…	I.T.S. Implantat-Technologie-Systeme GmbH	2008	—
*	K080184	Distal Humeral Plates with Angular Stability Summary page 2 …K132945 (2/4) L.T.S. GmbH -510(k) Summary - l.T.S. - Distal Humeral 3.5mm Cortical Scew (1(080184) Synthes - MultiLoc Humeral Nailing System (K(120807) Smith & Nephew…	I.T.S. Implantat-Technologie-Systeme GmbH	2008	1
*	K120807	Synthes Multiloc Humeral Nailing System Summary page 2 …mmary - l.T.S. - Distal Humeral 3.5mm Cortical Scew (1(080184) Synthes - MultiLoc Humeral Nailing System (K(120807) Smith & Nephew - TriGen Straight Humeral Nail (K(032722) Stryker - T…	Synthes USA Products, LLC	2012	—
*	K032722	Trigen Straight Humeral Nail System Summary page 2 …080184) Synthes - MultiLoc Humeral Nailing System (K(120807) Smith & Nephew - TriGen Straight Humeral Nail (K(032722) Stryker - T2 Proximal Humeral Nailing System (K042396) Acumed - Pola…	Smith & Nephew, Inc.	2003	—
*	K042396	T2 Proximal Humeral Nail Summary page 2 …20807) Smith & Nephew - TriGen Straight Humeral Nail (K(032722) Stryker - T2 Proximal Humeral Nailing System (K042396) Acumed - Polarus Humeral Rod (K(920666, K(951673,1K951740) DEVICE DESCRIPTION: The LT.…	Howmedica Osteonics Corp.	2004	1
*	K920666	Intramedulary Fixation Rod Summary page 2 …umeral Nail (K(032722) Stryker - T2 Proximal Humeral Nailing System (K042396) Acumed - Polarus Humeral Rod (K(920666, K(951673,1K951740) DEVICE DESCRIPTION: The LT.S. IM Nail Systems CFN-CTN-CHN consists of Predicate…	Acu Med, Inc.	1992	—
*	K951673	Rod, Fixation, Intramedullary and Accessories Summary page 2 …l (K(032722) Stryker - T2 Proximal Humeral Nailing System (K042396) Acumed - Polarus Humeral Rod (K(920666, K(951673,1K951740) DEVICE DESCRIPTION: The LT.S. IM Nail Systems CFN-CTN-CHN consists of Predicate…	Acu Med, Inc.	1995	—
*	K951740	Intramedulary Fixation Rod Summary page 2 …722) Stryker - T2 Proximal Humeral Nailing System (K042396) Acumed - Polarus Humeral Rod (K(920666, K(951673,1K951740) DEVICE DESCRIPTION: The LT.S. IM Nail Systems CFN-CTN-CHN consists of Predicate type i…	Acu Med, Inc.	1995	1

Also cleared against K970097: 7 other devices →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K161327	Syntec Humeral Nail System	Syntec Scientific Corporation	2017	3
K141228	Aos 6.5MM Captured, Fully Threaded Cancellous Screw	Advanced Orthopaedic Solutions, Inc.	2014	2
K170972	Apex Tibial Nailing System	Orthoxel	2017	1
K260958	I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…	I.T.S. GmbH	2026	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?

The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
31 of the 70 ancestors have a recall of any class.
Of its descendants, K161327 (Syntec Scientific Corporation, 2017) has gone furthest, with 3 descendants of its own.
7 other devices also cite its predicate K970097.

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. 2014, 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?

The intended use of the LT.S. WW NIl Systems isto stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories: TheLiT.S. CEN - Cannuleted Femur Nail System is indicated for use in long bone femur fracture fixation which include: Open and closed femur shaft fractures: lntertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric…

Read the full statement (264 words)

The intended use of the LT.S. WW NIl Systems isto stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories:

TheLiT.S. CEN - Cannuleted Femur Nail System is indicated for use in long bone femur fracture fixation which include:

Open and closed femur shaft fractures: lntertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, mal-union and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty;

The system is not for spinal use.

The LT.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include:

Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comnminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies,such as for leg length discrepencies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss.

The system is not for spinal use.

The i.T.S. CHN - Cannuleted Humerel Nail System is indicated for use in long bone humerus fracture fixation which include:

Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgus-impacted 4 part fractures of the proximal humerus; Proximal humeral fractures with diaphyseal extension into the shaft: Pseudloarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and: Pathological and impending pathological fractures.

The system is not for spinal use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132945 · printed Nov 4, 2026

Cite this page

510(k) Report. “K132945: CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132945

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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

CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral Nail

Line of descent and top descendants

Other ancestors by year cleared

Descendants by year cleared

What was it cleared against? (21)

What descends from it? (10)

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

What does this lineage say?

How does its category compare?

What is it indicated for?

Also cleared against K970097

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