510(k) · Cleared

Cleared

Speedy Flap System

K130447510(k) TraditionalCleared Dec 22, 2014669-day reviewClass II21 CFR 882.5330

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

Jeil Medical Corporation · GXN Plate, Cranioplasty, Preformed, Non-Alterable

Cleared on Dec 22, 2014 as substantially equivalent to K040864 (Aesculap, 2004) and 1 other predicate after a 669-day review. Its family tree reaches back 3 generations to 1994.

Decided: Dec 22, 2014
Review: 669 days
Class: Class II
Product code: GXN
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K923705 (1994). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK923705 Aesculap Craniofacial Titanium Plates and ScrewsAesculap, Inc. · 1994
2 generations backK040864 Craniofix and CRANIOFIX2 Titanium Clamp SystemAesculap · 2004
1 generation backK122353 Crainfix 2 Titanium Clamp SystemAesculap, Inc. · 2012
This deviceK130447 Speedy Flap SystemJeil Medical Corporation · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K923705	Aesculap Craniofacial Titanium Plates and Screws	Aesculap, Inc.	1994	—
−2	K040864	Craniofix and CRANIOFIX2 Titanium Clamp System	Aesculap	2004	—
−1	K122353	Crainfix 2 Titanium Clamp System	Aesculap, Inc.	2012	—
0 (this device)	K130447	Speedy Flap System	Jeil Medical Corporation	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K130447, 1994–2014Source: 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 GXN? 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 GXN device

#1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 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? (2)

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
*	K040864	Craniofix and CRANIOFIX2 Titanium Clamp System Summary page 5 …30, 21 CFR 882.5250 Page 1 of 5 ▪ Review Panel: Neurology 6. Predicate Devices ▪ 510(k) Number: K040864 and K122353 ▪ Product Name: CranioFix and CranioFix 2 Titanium Clamp System ▪ Manufacturer’s Name: Aesculap, Inc.…	Aesculap	2004	—
*	K122353	Crainfix 2 Titanium Clamp System Summary page 5 …82.5250 Page 1 of 5 ▪ Review Panel: Neurology 6. Predicate Devices ▪ 510(k) Number: K040864 and K122353 ▪ Product Name: CranioFix and CranioFix 2 Titanium Clamp System ▪ Manufacturer’s Name: Aesculap, Inc. 7. Device…	Aesculap, Inc.	2012	—

Also cleared against K040864: 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 20 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
None of the 4 ancestors has a recall.
3 other devices also cite its predicate K040864.

How does its category compare?

All GXN devices

GXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GXN

2in 2025

2007high 5 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXN

69in 2021

2007high 199 (2018) · low 33 (2020)2026

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

Recalls per year · GXN

6in 2018

2007high 6 (2018) · low 0 (2007)2026

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

Adverse event reports per year · GXN

24in 2025

2007high 74 (2017) · low 3 (2007)2025

MAUDE reports naming product code GXN, 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	2	—	0	3
2008	1	—	0	17
2009	0	—	0	17
2010	0	—	0	23
2011	2	—	0	20
2012	3	102	0	29
2013	1	—	0	57
2014	2	—	0	60
2015	2	—	0	47
2016	1	—	0	35
2017	2	—	0	74
2018	3	199	6	56
2019	0	—	0	54
2020	5	33	0	63
2021	3	69	0	63
2022	2	—	0	57
2023	1	—	0	32
2024	1	—	0	35
2025	2	—	0	24
2026	4	193	0	—

What is it indicated for?

Speedy Flap System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130447 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130447: Speedy Flap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130447

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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