510(k) · Cleared

Cleared

Intramedullary Nail and Screws-Neonail

K141103510(k) TraditionalCleared Sep 23, 2014147-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

Neoortho Produtos Ortopedicos S/A · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Sep 23, 2014 as substantially equivalent to K010801 (Howmedica Osteonics Corp., 2001) and 4 other predicates after a 147-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.

Decided: Sep 23, 2014
Review: 147 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K951740 (1995). 21 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
5 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
4 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
3 generations backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
2 generations backK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
1 generation backK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
This deviceK141103 Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A · 2014
Descendant · cites it directly · 0 of its ownK221021 Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A · 2022

Most influential descendants

Showing 1 of 1 · See all

K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K951740	Intramedulary Fixation Rod	Acu Med, Inc.	1995	1
−5	K032722	Trigen Straight Humeral Nail System	Smith & Nephew, Inc.	2003	—
−4	K051557	Trigen Retrograde Femoral, Supracondylar and Tibial Nails	Smith & Nephew, Inc.	2005	—
−3	K061019	Trigen Meta-Nail Retrograde Femoral and Tibial Nails	Smith & Nephew, Inc.	2006	1
−2	K111667	Synthes Suprapatellar Insertion Instruments	Synthes (Usa)	2011	1
−1	K131365	T2 Tibial Nailing System	Stryker Trauma AG	2013	4
0 (this device)	K141103	Intramedullary Nail and Screws-Neonail	Neoortho Produtos Ortopedicos S/A	2014	—
+1	K221021	Femoral Trochanteric Nail System – Neonail	Neoortho Produtos Ortopédicos S/A	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2000	1	0
2001	3	0
2002	2	0
2003	1	0
2004	3	0
2008	1	0
2011	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K141103, 1995–2022Source: 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? (5)

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
*	K010801	T2 Femoral Nail Summary page 6 …d Screws – NEONAIL is substantially equivalent in indications and design principles to the following predicate devices:  Howmedica Osteonics Corp., T2 Femoral Nail, K010801  Stryker, T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCP, K112059  Stryker Trauma AG, T2 Tibial Nailing System, K131365…	Howmedica Osteonics Corp.	2001	2
*	K112059	T2 Femoral Nail Model 1825-Xxxxcp, 1828-Xxxxcp Summary page 6 …n principles to the following predicate devices:  Howmedica Osteonics Corp., T2 Femoral Nail, K010801  Stryker, T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCP, K112059  Stryker Trauma AG, T2 Tibial Nailing System, K131365  Howmedica Osteonics Corp., T2 Proximal Humeral Nail, K042396…	Stryker	2011	—
*	K131365	T2 Tibial Nailing System Summary page 6 …edica Osteonics Corp., T2 Femoral Nail, K010801  Stryker, T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCP, K112059  Stryker Trauma AG, T2 Tibial Nailing System, K131365  Howmedica Osteonics Corp., T2 Proximal Humeral Nail, K042396  Howmedica Osteonics Corp., T2 Nailing System, K032523 I…	Stryker Trauma AG	2013	4
*	K042396	T2 Proximal Humeral Nail Summary page 6 …emoral Nail Model 1825-XXXXCP, 1828-XXXXCP, K112059  Stryker Trauma AG, T2 Tibial Nailing System, K131365  Howmedica Osteonics Corp., T2 Proximal Humeral Nail, K042396  Howmedica Osteonics Corp., T2 Nailing System, K032523 Intramedullary Nail and Screws – NEONAIL components have similar des…	Howmedica Osteonics Corp.	2004	1
*	K032523	T2 Nailing System Summary page 6 …ryker Trauma AG, T2 Tibial Nailing System, K131365  Howmedica Osteonics Corp., T2 Proximal Humeral Nail, K042396  Howmedica Osteonics Corp., T2 Nailing System, K032523 Intramedullary Nail and Screws – NEONAIL components have similar designs and identical materials as those cleared under K010801,…	Howmedica Osteonics Corp.	2003	—

Also cleared against K010801: 11 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K221021	Femoral Trochanteric Nail System – Neonail	Neoortho Produtos Ortopédicos S/A	2022	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 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
11 of the 21 ancestors have a recall of any class.
Of its descendants, K221021 (Neoortho Produtos Ortopédicos S/A, 2022) has gone furthest, with 0 descendants of its own.
11 other devices also cite its predicate K010801.

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?

Intramedullary Nail and Screws for Femur – NEONAIL is indicated for femoral fracture fixation including: • Open and closed femoral fractures; • Pseudoarthrosis and correction osteotomy; • Pathologic fractures, impending pathologic fractures, and tumor resections; • Ipsilateral femur fractures; • Fractures distal to the hip joint; and • Nonunions and malunions. Intramedullary Nail and Screws for Tibia – NEONAIL is intended to provide temporary…

Read the full statement (190 words)

Intramedullary Nail and Screws for Femur – NEONAIL is indicated for femoral fracture fixation including:

• Open and closed femoral fractures;

• Pseudoarthrosis and correction osteotomy;

• Pathologic fractures, impending pathologic fractures, and tumor resections;

• Ipsilateral femur fractures;

• Fractures distal to the hip joint; and

• Nonunions and malunions.

Intramedullary Nail and Screws for Tibia – NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia – NEONAIL is indicated for tibial fracture fixation, which may include:

• Open and closed tibial fractures;

• Pseudoarthodlosis and correction osteotomy;

• Pathologic fractures, impending pathologic fractures and tumor resections; and

• Nonunions and malunions.

The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K141103 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141103: Intramedullary Nail and Screws-Neonail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141103

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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