510(k) · Cleared
ClearedTrupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. · IYE Accelerator, Linear, Medical
Cleared on Mar 4, 2014 as substantially equivalent to K112210 (Medical Intelligence Medizintechnik GmbH, 2011) after a 168-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Mar 4, 2014
- Review
- 168 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924849 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK924849 Leksell Gamma Unit Model 23004,Type B.Elekta Radiosurgery, Inc. · 1995
- 5 generations backK984328 Leksell Gamma Knife Target System, Model 24001Elekta Instrument AB · 1999 · Recalled
- 4 generations backK061941 Leksell Gamma Knife Perfexion, Model 715000Elekta Instrument AB · 2006
- 3 generations backK063512 Leksell Gamma Knife PerfexionElekta Instrument AB · 2007 · Recalled
- 2 generations backK092083 Extend Frame System, Model 1009633Elekta Instrument AB · 2009 · Recalled
- 1 generation backK112210 FraxionMedical Intelligence Medizintechnik GmbH · 2011
- This deviceK132908 Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage…Medtec, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924849 | Leksell Gamma Unit Model 23004,Type B. | Elekta Radiosurgery, Inc. | 1995 | — |
| −5 | K984328 | Leksell Gamma Knife Target System, Model 24001 | Elekta Instrument AB | 1999 | 4 |
| −4 | K061941 | Leksell Gamma Knife Perfexion, Model 715000 | Elekta Instrument AB | 2006 | — |
| −3 | K063512 | Leksell Gamma Knife Perfexion | Elekta Instrument AB | 2007 | 4 |
| −2 | K092083 | Extend Frame System, Model 1009633 | Elekta Instrument AB | 2009 | 1 |
| −1 | K112210 | Fraxion | Medical Intelligence Medizintechnik GmbH | 2011 | — |
| 0 (this device) | K132908 | Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint… | Medtec, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K982019 | Med-Tec Head Immobilization System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…Technological characteristics that have changed between the proposed device and Med- Tec Head Immobilization System (K982019) predicate device include changes in design and materials. The design changes include the addition of… | |
| * | K112210 | FraxionSummary page 3…MED ICGAL SO0L U TO1N S The technological differences between the proposed device and the Fraxion TM (K1 12210) predicate device include differences in design and materials. Both devices feature a… | 2011 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 9 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The device is intended to be used for immobilization, positioning and re-positioning during Stereotactic Radiotherapy (SRT) and Stereotactic Radiosurgery (SRS) in all parts of the brain, head, and neck during external beam radiation therapy. The device is also used to immobilize and position the head during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132908 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132908: Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132908
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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