510(k) · Cleared

Cleared

Interlocking Tibial Nailing System

K915435510(k) TraditionalCleared Mar 2, 199290-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

Stryker Corp. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Mar 2, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.

Decided: Mar 2, 1992
Review: 90 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 0

12 later devices descend from it, 1 citing it directly.

This deviceK915435 Interlocking Tibial Nailing SystemStryker Corp. · 1992
Descendant · cites it directly · 11 of its ownK080706 Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008
Descendant · 2 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
Descendant · 3 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
Descendant · 4 generations on · 2 of its ownK181296 Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019
Descendant · 3 generations on · 2 of its ownK141228 Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008high 2 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all

K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH · 2008 · cites it directly11descendants
K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 2 generations on10descendants
K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 3 generations on3descendants
K181296Syntec Femoral Nail SystemSyntec Scientific Corporation · 2019 · 4 generations on2descendants
K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc. · 2014 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K915435	Interlocking Tibial Nailing System	Stryker Corp.	1992	—
+1	K080706	Connexx Locking Tibia Nail	I.T.S. Implantat-Technologie-Systeme GmbH	2008	—
+2	K132945	CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…	I.T.S. GmbH	2014	—
+3	K161327	Syntec Humeral Nail System	Syntec Scientific Corporation	2017	—
+4	K181296	Syntec Femoral Nail System	Syntec Scientific Corporation	2019	—
+3	K141228	Aos 6.5MM Captured, Fully Threaded Cancellous Screw	Advanced Orthopaedic Solutions, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2014	2	0
2017	2	0
2019	2	0
2020	1	0
2023	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K915435, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K080706	Connexx Locking Tibia Nail	I.T.S. Implantat-Technologie-Systeme GmbH	2008	11

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?

Of its descendants, K080706 (I.T.S. Implantat-Technologie-Systeme GmbH, 2008) has gone furthest, with 11 descendants of its own.

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	—

https://510kreport.com/device/K915435 · printed Nov 4, 2026

Cite this page

510(k) Report. “K915435: Interlocking Tibial Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K915435

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026