510(k) · Cleared

Recalled · 2002

Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System

K012967510(k) SpecialCleared Oct 4, 200130-day reviewClass II21 CFR 888.3020Recalls 1

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

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

Cleared on Oct 4, 2001 as substantially equivalent to K010988 (Disc-O-Tech Medical Technologies, Ltd., 2001) after a 30-day review. Its family tree reaches back 2 generations to 1997. 56 later devices descend from it. It has been recalled once.

Decided: Oct 4, 2001
Review: 30 days
Class: Class II
Product code: HSB
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K970097 (1997). 3 ancestors in all. 56 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 2 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
1 generation backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
This deviceK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001
Descendant · cites it directly · 54 of its ownK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
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 · 2 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2002high 5 (2020) · low 0 (2005)2026

Most influential descendants

Showing 5 of 56 · See all

K021324Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · cites it directly54descendants
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 · 2 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970097	Proximal Femoral Nail (PFN) System	Synthes (Usa)	1997	—
−1	K010988	Fixion Interlocking Proximal Femoral Nailing System	Disc-O-Tech Medical Technologies, Ltd.	2001	1
0 (this device)	K012967	Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing…	Disco-O-Tech Medical Technologies, Ltd.	2001	—
+1	K021324	Fixion Intramedullary Nailing System (Fixion IM Nailing System)	Disco-O-Tech Medical Technologies, Ltd.	2002	1
+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	—
+2	K091425	Quantum M Composite Nailing System	N.M.B. Medical Applications, Ltd.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	4	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 K012967, 1997–2026Source: 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? (1)

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
*	K010988	Fixion Interlocking Proximal Femoral Nailing System Summary page 1 …tem (Fixion PF) Classification Name Intramedullary Fixation Rod 21 CFR § 888.3020 Class I1 Predicate Devices 1. Fixion Interlocking PF Intramedullary Nailing System (K010988) by Disc-O-Tech 2. Fixion Intramedullary Nailing System (K990717, K003212, K003215, K010901) by Disc-O-Tech 3. Fixion Interlock…	Disc-O-Tech Medical Technologies, Ltd.	2001	1

Also cleared against K010988: 11 other devices →

What descends from it? (56)

See all 56

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

Number	Device	Applicant	Decided	Descendants
K021324	Fixion Intramedullary Nailing System (Fixion IM Nailing System)	Disco-O-Tech Medical Technologies, Ltd.	2002	54
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
K032358	B-Twin Bone Expander System (B-Twin BE System)	Disc-O-Tech Medical Technologies, Ltd.	2003	16
K151010	Piccolo Composite Nailing System	CarboFix Orthopedics, Ltd.	2015	2
K030972	Fixion Unipolar Modular Hemi-Hip System (Fixion MH)	Disc-O-Tech Medical Technologies, Ltd.	2003	1
K071679	Metafix and Fixion FA Intramedullary Nailing Systems	Disc-O-Tech Medical Technologies, Ltd.	2007	0
K032730	Fixion Hip System	Disc-O-Tech Medical Technologies, Ltd.	2004	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 11, 2002	Not classified	Z-0943-03	Other	The Fixion Interlocking Proximal Femoral Hip Pegs are defective due to possible tension failure.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K021324 (Disco-O-Tech Medical Technologies, Ltd., 2002) has gone furthest, with 54 descendants of its own.
11 other devices also cite its predicate K010988.

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 Proximal Femoral Nailing System (“Fixion PF”) is intended for use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures. Proximal femoral fractures include stable and unstable pertrochanteric, intertrochanteric and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures…

Read the full statement (120 words)

The Fixion Interlocking Proximal Femoral Nailing System (“Fixion PF”) is intended for

use in fixation of fractures in the femur. The Fixion PF is indicated for use in fractures in

the femur shaft, proximal femoral fractures, and combinations of these fractures. Proximal

femoral fractures include stable and unstable pertrochanteric, intertrochanteric and

subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric

fractures and combinations of these fractures. The long Fixion PF may also be used in mid

shaft fractures, 5cm below the surgical neck to Scm proximal to the distal end of the

medullar canal.

The Fixion PF is also indicated for use in osteotomy, nonunions and malunions, bone

reconstruction following tumor resection, grafting and pathological fractures, revision

procedures.

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/K012967 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012967: Modification to Fixion Interlocking Proximal Femoral Intramedullary 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/K012967

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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