510(k) · Cleared

Cleared

IDEAL

K132428510(k) TraditionalCleared Dec 20, 2013137-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

Jiangsu Ideal Medical Science & Technology Co., LT · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Dec 20, 2013 as substantially equivalent to K121312 (Weigao Orthopaedic Device Co., Ltd., 2012) after a 137-day review. Its family tree reaches back 2 generations to 2005.

Decided: Dec 20, 2013
Review: 137 days
Class: Class II
Product code: HSB
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K053261 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK053261 Orthofix Titanium Nailing SystemsOrthofix Srl · 2005
1 generation backK121312 Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd. · 2012
This deviceK132428 IDEALJiangsu Ideal Medical Science & Technology Co., LT · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K053261	Orthofix Titanium Nailing Systems	Orthofix Srl	2005	—
−1	K121312	Intramedullary Nail System	Weigao Orthopaedic Device Co., Ltd.	2012	—
0 (this device)	K132428	IDEAL	Jiangsu Ideal Medical Science & Technology Co., LT	2013	—

FIG. 1 — Lineage of K132428, 2005–2013Source: 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
*	K121312	Intramedullary Nail System Summary page 1 …y fixation rod Device Class; Class 11 Classification Panel: Orthopedic Panel Product Code: lASH Regulation Number: 21 CER 888.3020 4. Predicate Devices 510 (k) Number: K 121312 Product Name: Intrmedullary Nail System Submitter: Weigao Orthopaedic Device Co.. Ltd. 5. Device Description The [deal T" Intr…	Weigao Orthopaedic Device Co., Ltd.	2012	—

Also cleared against K121312: 1 other device →

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 8 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K121312.

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. 2013, 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?

The IdealTM Intramedullary Nail System is intended to provide temporary fracture fixation and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132428 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132428: IDEAL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132428

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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