510(k) · Cleared

Cleared

Rapidflap Cranial Clamp

K991029510(k) SpecialCleared Apr 23, 199925-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

Walter Lorenz Surgical, Inc. · GXN Plate, Cranioplasty, Preformed, Non-Alterable

Cleared on Apr 23, 1999 as substantially equivalent to K971252 (Ikonos Corp., 1998) after a 25-day review. Its family tree reaches back 1 generation to 1998. 72 later devices descend from it.

Decided: Apr 23, 1999
Review: 25 days
Class: Class II
Product code: GXN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971252 (1998). 72 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
This deviceK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
Descendant · cites it directly · 63 of its ownK031034 Spin Down RapidflapWalter Lorenz Surgical, Inc. · 2003 · Recalled
Descendant · cites it directly · 63 of its ownK022277 Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
Descendant · 2 generations on · 62 of its ownK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Descendant · 4 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2000high 14 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 72 · See all

K031034Spin Down RapidflapWalter Lorenz Surgical, Inc. · 2003 · cites it directly63descendants
K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003 · cites it directly63descendants
K062857KLS Martin Quick DiscKLS Martin L.P. · 2006 · 2 generations on62descendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 4 generations on45descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971252	Sevrain Cranial Clamp	Ikonos Corp.	1998	—
0 (this device)	K991029	Rapidflap Cranial Clamp	Walter Lorenz Surgical, Inc.	1999	—
+1	K031034	Spin Down Rapidflap	Walter Lorenz Surgical, Inc.	2003	6
+1	K022277	Osteomed Cranial Flap Fixation System	Osteomed Corp.	2003	—
+2	K062857	KLS Martin Quick Disc	KLS Martin L.P.	2006	—
+3	K070169	KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile	KLS Martin L.P.	2007	—
+4	K151983	KLS Martin LSS Plating System	KLS Martin L.P.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2002	1	0
2003	3	0
2005	1	0
2006	1	0
2007	2	0
2008	1	0
2011	1	0
2012	1	0
2013	1	0
2014	3	0
2015	2	0
2016	2	0
2021	3	0
2022	3	0
2023	8	0
2024	12	0
2025	14	0
2026	11	0

FIG. 1 — Lineage of K991029, 1998–2026Source: 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 GXN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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#1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 generations · no Class I recall
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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
*	K971252	Sevrain Cranial Clamp Summary page 1 …Kaalo 29 Summary of Safety and Effectiveness Device Modification Name: RapidFlap Cranial Clamp Name of previously cleared 510(k): Sevrain Cranial Clamp SCC100 - 510(k) K971252 Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable Product Code and Reference: 84 GXN (21 CFR - 882.5330) Intend…	Ikonos Corp.	1998	—

Also cleared against K971252: 2 other devices →

What descends from it? (72)

See all 72

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

Number	Device	Applicant	Decided	Descendants
K031034	Spin Down Rapidflap	Walter Lorenz Surgical, Inc.	2003	63
K022277	Osteomed Cranial Flap Fixation System	Osteomed Corp.	2003	63
K993990	Leibinger Quik Disk Titanium Clamp System	Stryker Instruments	2000	6
K013050	The Bioplate Zip Craniotomy Fixation System	Bioplate, Inc.	2001	4
K020088	Modification of the Bioplate Zip Craniotomy Fixation System	Bioplate, Inc.	2002	2
K030378	Stryker Leibinger Cranial Fixation System	Stryker Instruments	2003	0

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?

Its one ancestor has no recall.
Of its descendants, K031034 (Walter Lorenz Surgical, Inc., 2003) has gone furthest, with 63 descendants of its own.
2 other devices also cite its predicate K971252.

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.

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?

RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.

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/K991029 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991029: Rapidflap Cranial Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991029

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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