510(k) · Cleared
ClearedModified Plate Design for Bioplate Zip Craniotomy Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioplate, Inc. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Jun 15, 2007 as substantially equivalent to K013050 (Bioplate, Inc., 2001) and 1 other predicate after a 74-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Jun 15, 2007
- Review
- 74 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971252 (1998). 9 ancestors in all, the oldest K972332 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
- 4 generations backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
- 3 generations backK993990 Leibinger Quik Disk Titanium Clamp SystemStryker Instruments · 2000
- 2 generations backK013050 The Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2001
- 1 generation backK020088 Modification of the Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2002
- This deviceK070901 Modified Plate Design for Bioplate Zip Craniotomy Fixation SystemBioplate, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK082175 Mofication to: Modified Plate Design for Bioplate Zip Craniotomy…Bioplate, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082175Mofication to: Modified Plate Design for Bioplate Zip Craniotomy FixationBioplate, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971252 | Sevrain Cranial Clamp | Ikonos Corp. | 1998 | — |
| −4 | K991029 | Rapidflap Cranial Clamp | Walter Lorenz Surgical, Inc. | 1999 | — |
| −3 | K993990 | Leibinger Quik Disk Titanium Clamp System | Stryker Instruments | 2000 | — |
| −2 | K013050 | The Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2001 | — |
| −1 | K020088 | Modification of the Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2002 | — |
| 0 (this device) | K070901 | Modified Plate Design for Bioplate Zip Craniotomy Fixation System | Bioplate, Inc. | 2007 | — |
| +1 | K082175 | Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation | Bioplate, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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 |
|---|---|---|---|
| * | K013050 | The Bioplate Zip Craniotomy Fixation SystemSummary page 1…sification: Class 2, 21 CFR 882.5330 GXN Predicate Devices: (I.) Bioplate, Inc. The Bioplate®'ZIP® Craniotomy Fixation System (K013050) K070901 6/15/07.A Page 2 of 3 (2) Bioplate, In… | 2001 |
| * | K020088 | Modification of the Bioplate Zip Craniotomy Fixation SystemSummary page 1…6 (fax) Contact Person: Jesus Farinas Trade name of Device: Modified design of the Bioplate® ZIP® Craniotomy Fixation System. (KOl13050, K020088) Common Name: Plate, Cranioplasty, Preformed, Non-Alterable Device Classification: Class 2, 21 CFR… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082175 | Mofication to: Modified Plate Design for Bioplate Zip Craniotomy Fixation | 2008 | 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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K082175 (Bioplate, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K013050.
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. 2007, this device’s year, is highlighted.
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?
The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070901: Modified Plate Design for Bioplate Zip Craniotomy Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070901
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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