510(k) · Cleared

Cleared

Fixion Hip System

K032730510(k) TraditionalCleared Mar 26, 2004205-day reviewClass II21 CFR 888.3350

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. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Mar 26, 2004 as substantially equivalent to K014072 (Disc-O-Tech Medical Technologies, Ltd., 2002) and 11 other predicates after a 205-day review. Its family tree reaches back 5 generations to 1997.

Decided: Mar 26, 2004
Review: 205 days
Class: Class II
Product code: JDI
Recalls: None
Predicates: 12

Its longest line of descent runs back 5 generations to K970097 (1997). 37 ancestors in all, the oldest K803106 (1981). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
4 generations backK010988 Fixion Interlocking Proximal Femoral Nailing SystemDisc-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
3 generations backK012967 Modification to Fixion Interlocking Proximal Femoral Intramedullary…Disco-O-Tech Medical Technologies, Ltd. · 2001 · Recalled
2 generations backK021324 Fixion Intramedullary Nailing System (Fixion IM Nailing System)Disco-O-Tech Medical Technologies, Ltd. · 2002 · Recalled
1 generation backK023437 Fixion Interlocking Proximal Femur Intramedullary Nailing System…Disco-O-Tech Medical Technologies, Ltd. · 2002
This deviceK032730 Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K970097	Proximal Femoral Nail (PFN) System	Synthes (Usa)	1997	—
−4	K010988	Fixion Interlocking Proximal Femoral Nailing System	Disc-O-Tech Medical Technologies, Ltd.	2001	1
−3	K012967	Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing…	Disco-O-Tech Medical Technologies, Ltd.	2001	1
−2	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	—
0 (this device)	K032730	Fixion Hip System	Disc-O-Tech Medical Technologies, Ltd.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1985	1	0
1988	1	0
1989	1	0
1990	1	0
1991	1	0
1992	5	0
1993	3	0
1994	3	0
1996	5	0
1997	1	0
1999	1	0
2000	4	0
2001	2	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K032730, 1997–2004Source: 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 JDI? 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 JDI device

#1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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? (12)

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
*	K014072	Fixion Unipolar Modular Hemi-Hip System (Fixion UH) Summary page 2 …o Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH, K014072, K030972) by Disc-O-Tech Medical Technologies Ltd. Ul Hip System (K9940…	Disc-O-Tech Medical Technologies, Ltd.	2002	—
*	K030972	Fixion Unipolar Modular Hemi-Hip System (Fixion MH) Summary page 2 …o Fixion® Unipolar Modular Hemi-Hip System (Fixion® MH, K014072, K030972) by Disc-O-Tech Medical Technologies Ltd. Ul Hip System (K994078) by United Orthopedic Corporation.…	Disc-O-Tech Medical Technologies, Ltd.	2003	—
*	K994078	U1 Hip System Summary page 2 …Modular Hemi-Hip System (Fixion® MH, K014072, K030972) by Disc-O-Tech Medical Technologies Ltd. Ul Hip System (K994078) by United Orthopedic Corporation. ~1- Elite® Modular Hip System (K871867) by Depuy Orthopeadics.…	United Orthopedic Corp.	2000	—
*	K871867	Elite Modular Hip System Summary page 2 …72) by Disc-O-Tech Medical Technologies Ltd. Ul Hip System (K994078) by United Orthopedic Corporation. ~1- Elite® Modular Hip System (K871867) by Depuy Orthopeadics. S-ROM® Total Hip System (K851422, K913231, K954935, K961939) by Depuy…	Thackray USA	1988	—
*	K851422	S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip Summary page 2 …m (K994078) by United Orthopedic Corporation. ~1- Elite® Modular Hip System (K871867) by Depuy Orthopeadics. S-ROM® Total Hip System (K851422, K913231, K954935, K961939) by Depuy Orthopeadics. 7' Link® MP® Hip System…	Joint Medical Products Corp.	1985	—
*	K913231	S-Rom (TM) Total Lhip System W/Ceramic Head Summary page 2 …8) by United Orthopedic Corporation. ~1- Elite® Modular Hip System (K871867) by Depuy Orthopeadics. S-ROM® Total Hip System (K851422, K913231, K954935, K961939) by Depuy Orthopeadics. 7' Link® MP® Hip System (K955296…	Joint Medical Products Corp.	1991	—
*	K954935	S-Rom Femoral Hip Stem - Size 14 X 8 Summary page 2 …ted Orthopedic Corporation. ~1- Elite® Modular Hip System (K871867) by Depuy Orthopeadics. S-ROM® Total Hip System (K851422, K913231, K954935, K961939) by Depuy Orthopeadics. 7' Link® MP® Hip System (K955296) by Link…	Joint Medical Products Corp.	1996	—
*	K961939	S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) Summary page 2 …pedic Corporation. ~1- Elite® Modular Hip System (K871867) by Depuy Orthopeadics. S-ROM® Total Hip System (K851422, K913231, K954935, K961939) by Depuy Orthopeadics. 7' Link® MP® Hip System (K955296) by Link America…	Johnson & Johnson Professionals, Inc.	1996	—
*	K955296	Link MP Reconstruction Hip Summary page 2 …S-ROM® Total Hip System (K851422, K913231, K954935, K961939) by Depuy Orthopeadics. 7' Link® MP® Hip System (K955296) by Link America Inc. Fixion® Interlocking Proximal Femoral Intramedullary Nailing System…	Link America, Inc.	1996	21
*	K010988	Fixion Interlocking Proximal Femoral Nailing System Summary page 2 …K955296) by Link America Inc. Fixion® Interlocking Proximal Femoral Intramedullary Nailing System (Fixion® PF, K010988, K012967, K0…	Disc-O-Tech Medical Technologies, Ltd.	2001	1
*	K012967	Modification to Fixion Interlocking Proximal Femoral Intramedullary Nailing System Summary page 2 …ral Intramedullary Nailing System (Fixion® PF, K010988, K012967, K023437) by Disc-O-Tech Medical Technologies Ltd. Performan…	Disco-O-Tech Medical Technologies, Ltd.	2001	1
*	K023437	Fixion Interlocking Proximal Femur Intramedullary Nailing System (Fixion PF Nailing… Summary page 2 …(Fixion® PF, K010988, K012967, K023437) by Disc-O-Tech Medical Technologies Ltd. Performance Standards The following standards we…	Disco-O-Tech Medical Technologies, Ltd.	2002	—

Also cleared against K014072: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 7 years and passes through 3 companies; a new generation was cleared every 8 months on median.
5 of the 37 ancestors have a recall of any class.
3 other devices also cite its predicate K014072.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007high 247 (2020) · low 59 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDI

1in 2025

2007high 77 (2020) · low 0 (2021)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDI

1,644in 2025

2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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	3	81	26	696
2008	5	96	6	810
2009	3	65	3	964
2010	0	—	3	2,040
2011	2	—	5	3,160
2012	4	167	4	5,122
2013	3	176	11	5,206
2014	3	98	3	4,968
2015	3	190	1	4,906
2016	4	166	5	3,995
2017	1	—	5	6,135
2018	1	—	1	6,728
2019	2	—	1	7,407
2020	7	247	77	4,015
2021	3	162	0	3,170
2022	3	69	0	1,978
2023	2	—	0	1,635
2024	3	59	0	1,821
2025	1	—	1	1,644
2026	2	—	0	—

What is it indicated for?

The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement. The Fixion® Hip System is indicated as a unipolar hemi-hip replacement in cases of: Femoral head and/or neck fractures or non-unions. Aseptic necrosis of the femoral head and/or neck. Osteo-, rheumatoid-, and/or post-traumatic arthritis of the hip, with minimal acetabular involvement. The Fixion® Hip System is indicated as a total hip replacement in cases of: Painful…

Read the full statement (129 words)

The Fixion® Hip System is intended for use as a hemi-hip or total hip replacement.

The Fixion® Hip System is indicated as a unipolar hemi-hip replacement in cases of:

Femoral head and/or neck fractures or non-unions.

Aseptic necrosis of the femoral head and/or neck.

Osteo-, rheumatoid-, and/or post-traumatic arthritis of the hip, with minimal acetabular involvement.

The Fixion® Hip System is indicated as a total hip replacement in cases of:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.

Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

The Fixion® Hip Stem is intended for cemented or non-cemented use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032730: Fixion Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032730

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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