510(k) · Cleared

Cleared

Modification to Fixion Interlocking Intramedullary Nailing System

K013449510(k) TraditionalCleared Dec 19, 200163-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

Disc-O-Tech Medical Technologies, Ltd. · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 19, 2001 as substantially equivalent to K002783 (Disco-O-Tech Medical Technologies, Ltd., 2000) and 9 other predicates after a 63-day review. Its family tree reaches back 2 generations to 1981. 54 later devices descend from it.

Decided: Dec 19, 2001
Review: 63 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 10

Its longest line of descent runs back 2 generations to K803106 (1981). 17 ancestors in all. 54 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 2 generations backK803106 Aginsky NailCintor Orthopaedic Div. · 1981
1 generation backK990717 Fixion Intramedullary Nailing SystemDisco-O-Tech Medical Technologies, Ltd. · 1999
This deviceK013449 Modification to Fixion Interlocking Intramedullary Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001
Descendant · cites it directly · 53 of its ownK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
Descendant · cites it directly · 32 of its ownK032588 Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003
Descendant · cites it directly · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
Descendant · cites it directly · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
Descendant · 2 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2002high 5 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 54 · See all

K023437Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…Disco-O-Tech Medical Technologies, Ltd. · 2002 · cites it directly53descendants
K032588Modification to Fixion Intramedullary Nailing System (Fixion IM)Disco-O-Tech Medical Technologies, Ltd. · 2003 · cites it directly32descendants
K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003 · cites it directly32descendants
K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · cites it directly31descendants
K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 2 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K803106	Aginsky Nail	Cintor Orthopaedic Div.	1981	—
−1	K990717	Fixion Intramedullary Nailing System	Disco-O-Tech Medical Technologies, Ltd.	1999	—
0 (this device)	K013449	Modification to Fixion Interlocking Intramedullary Nailing System	Disc-O-Tech Medical Technologies, Ltd.	2001	—
+1	K023437	Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF…	Disco-O-Tech Medical Technologies, Ltd.	2002	—
+1	K032588	Modification to Fixion Intramedullary Nailing System (Fixion IM)	Disco-O-Tech Medical Technologies, Ltd.	2003	—
+1	K031401	Fixion Dynamic Hip Screw System (Fixion DHS)	Disco-O-Tech Medical Technologies, Ltd.	2003	—
+1	K091425	Quantum M Composite Nailing System	N.M.B. Medical Applications, Ltd.	2010	—
+2	K100497	Quantum IM Composite Nailing System (Quantum Nailing System)	N.M.B. Medical Applications, Ltd.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	1	0
1992	3	0
1993	3	0
1994	1	0
1996	1	0
1997	1	0
2000	3	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2004	4	0
2006	1	0
2007	2	0
2009	1	0
2010	2	0
2011	3	0
2012	1	0
2013	4	0
2014	2	0
2015	2	0
2016	3	0
2017	3	0
2018	2	0
2019	3	0
2020	5	0
2021	2	0
2022	2	0
2023	2	0
2024	2	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K013449, 1981–2026Source: 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? (10)

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
*	K002783	Fixion Interlocking Nail (Fixion IL Nail) Summary page 1 …on Name Intramedullary Fixation Rod 21 CFR § 888.3020 Class II Predicate Devices 1. Fixion Interlocking Intramedullary Nailing System (Fixion IL Nail) by the company - K002783 2. Fixion Intramedullary Nailing System (Fixion IM Nail) by the company — K990717, K003212, K003215, K010901 . Unreamed Humeral…	Disco-O-Tech Medical Technologies, Ltd.	2000	—
*	K990717	Fixion Intramedullary Nailing System Summary page 1 …1. Fixion Interlocking Intramedullary Nailing System (Fixion IL Nail) by the company - K002783 2. Fixion Intramedullary Nailing System (Fixion IM Nail) by the company — K990717, K003212, K003215, K010901 . Unreamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed…	Disco-O-Tech Medical Technologies, Ltd.	1999	—
*	K003212	Fixion Intramedullary Nailing System (Fixion IM Nail) Summary page 1 …Interlocking Intramedullary Nailing System (Fixion IL Nail) by the company - K002783 2. Fixion Intramedullary Nailing System (Fixion IM Nail) by the company — K990717, K003212, K003215, K010901 . Unreamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed Femoral…	Disco-O-Tech Medical Technologies, Ltd.	2000	—
*	K003215	Modification of Fixion Intramedullary Nailing System (Fixion IM Nail) Summary page 1 …king Intramedullary Nailing System (Fixion IL Nail) by the company - K002783 2. Fixion Intramedullary Nailing System (Fixion IM Nail) by the company — K990717, K003212, K003215, K010901 . Unreamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed Femoral Nail by S…	Disco-O-Tech Medical Technologies, Ltd.	2000	—
*	K010901	Fixion Intramedullary Nailing System (Fixion Imn) Model B Summary page 1 …amedullary Nailing System (Fixion IL Nail) by the company - K002783 2. Fixion Intramedullary Nailing System (Fixion IM Nail) by the company — K990717, K003212, K003215, K010901 . Unreamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed Femoral Nail by Synthes -…	Disc-O-Tech Medical Technologies, Ltd.	2001	—
*	K933518	Synthes Unreamed Humeral Nail (Urhn) Summary page 1 …the company - K002783 2. Fixion Intramedullary Nailing System (Fixion IM Nail) by the company — K990717, K003212, K003215, K010901 . Unreamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed Femoral Nail by Synthes - K923580 . Ti Distal Femoral Nail by Synthes -…	Synthes (Usa)	1994	—
*	K914453	Universal Tibial Nail and Unreamed Tibial Nail Summary page 1 …ry Nailing System (Fixion IM Nail) by the company — K990717, K003212, K003215, K010901 . Unreamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed Femoral Nail by Synthes - K923580 . Ti Distal Femoral Nail by Synthes - K970733 . True/Flex Upper Extremity IM Nail…	Synthes (Usa)	1992	—
*	K923580	Synthes TI-6AI-7NB Unreamed Femoral Nail Summary page 1 …any — K990717, K003212, K003215, K010901 . Unreamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed Femoral Nail by Synthes - K923580 . Ti Distal Femoral Nail by Synthes - K970733 . True/Flex Upper Extremity IM Nail by Encore (Applied Osteo Systems, Inc.) - K90…	Synthes (Usa)	1993	—
*	K970733	Synthes Titanium Diastal Femoral Nail (TI DFN) System Summary page 1 …eamed Humeral Nail by Synthes — K933518 . Unreamed Tibial Nail by Synthes - K914453 . Unreamed Femoral Nail by Synthes - K923580 . Ti Distal Femoral Nail by Synthes - K970733 . True/Flex Upper Extremity IM Nail by Encore (Applied Osteo Systems, Inc.) - K902264 NN AW Performance Standards The followi…	Synthes (Usa)	1997	1
*	K902264	True/Flex Humerus, Ulna and Radius Intramedullary Summary page 1 …Unreamed Femoral Nail by Synthes - K923580 . Ti Distal Femoral Nail by Synthes - K970733 . True/Flex Upper Extremity IM Nail by Encore (Applied Osteo Systems, Inc.) - K902264 NN AW Performance Standards The following standards were used: 1. The Fixion IL Nail is manufactured from 316L Stainless Stee…	Applied Osteo Systems, Inc.	1990	—

Also cleared against K002783: 7 other devices →

What descends from it? (54)

See all 54

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

Number	Device	Applicant	Decided	Descendants
K023437	Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing…	Disco-O-Tech Medical Technologies, Ltd.	2002	53
K032588	Modification to Fixion Intramedullary Nailing System (Fixion IM)	Disco-O-Tech Medical Technologies, Ltd.	2003	32
K031401	Fixion Dynamic Hip Screw System (Fixion DHS)	Disco-O-Tech Medical Technologies, Ltd.	2003	32
K091425	Quantum M Composite Nailing System	N.M.B. Medical Applications, Ltd.	2010	31
K102369	Piccolo Composite Nailing System	N.M.B. Medical Applications, Ltd.	2011	16
K111056	Piccolo Composite Nailing System	CarboFix Orthopedics, Ltd.	2011	15

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 20 years and passes through 3 companies; a new generation was cleared every 18.3 years on median.
1 of the 17 ancestors has a recall of any class.
Of its descendants, K023437 (Disco-O-Tech Medical Technologies, Ltd., 2002) has gone furthest, with 53 descendants of its own.
7 other devices also cite its predicate K002783.

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?

The Fixion™ Interlocking Intramedullary Nail is intended for use in fixation of various types of fractures, including diaphyseal fractures and short distal or proximal fragments in the long bones.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013449 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013449: Modification to Fixion Interlocking Intramedullary Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013449

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026