510(k) · Cleared
Recalled · Class II · 2018Spin Down Rapidflap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on May 21, 2003 as substantially equivalent to K971252 (Ikonos Corp., 1998) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1998. 63 later devices descend from it. It has been recalled 6 times.
- Decided
- May 21, 2003
- Review
- 50 days
- Class
- Class II
- Product code
- GXN
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971252 (1998). 63 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
- 1 generation backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
- This deviceK031034 Spin Down RapidflapWalter Lorenz Surgical, Inc. · 2003
- Descendant · cites it directly · 62 of its ownK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
- Descendant · 2 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- Descendant · 3 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
- Descendant · 4 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
- Descendant · 5 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K062857KLS Martin Quick DiscKLS Martin L.P. · 2006 · cites it directly62descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 2 generations on61descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 3 generations on45descendants
- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 4 generations on39descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 5 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971252 | Sevrain Cranial Clamp | Ikonos Corp. | 1998 | — |
| −1 | K991029 | Rapidflap Cranial Clamp | Walter Lorenz Surgical, Inc. | 1999 | — |
| 0 (this device) | K031034 | Spin Down Rapidflap | Walter Lorenz Surgical, Inc. | 2003 | — |
| +1 | K062857 | KLS Martin Quick Disc | KLS Martin L.P. | 2006 | — |
| +2 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| +3 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
| +4 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
| +5 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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 |
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
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 | Decided |
|---|---|---|---|
| * | K971252 | Sevrain Cranial ClampSummary page 1…ummary of Safety and Effectiveness Device Modification Name: Spin down rapidflap Name of previously cleared 510(k): Sevrain Cranial Clamp SCC 100 - 5 1O(k) K97 1252 RapidFlap Cranial Clamp - 5 1k(k) K99 10229 Classification Name: Plate, Craniopla… | 1998 |
| * | K991029 | Rapidflap Cranial ClampSummary page 1…r the re-attachment of the bone flap after a craniotomy. Device Modification Descriotion: Spin Down RapidFlap K99 1029 RapidFlap modification Cranial Clamu Attachment of Threaded st… | 1999 |
What descends from it? (63)
See all 631 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062857 | KLS Martin Quick Disc | 2006 | 62 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2018 | Class II | Z-0393-2019 | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| Aug 22, 2018 | Class II | Z-0394-2019 | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| Aug 22, 2018 | Class II | Z-0395-2019 | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| Aug 22, 2018 | Class II | Z-0398-2019 | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| Aug 22, 2018 | Class II | Z-0396-2019 | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| Aug 22, 2018 | Class II | Z-0397-2019 | Process control | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062857 (KLS Martin L.P., 2006) has gone furthest, with 62 descendants of its own.
- 2 other devices also cite its predicate K971252.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 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?
Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031034: Spin Down Rapidflap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031034
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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