510(k) · Cleared
ClearedStryker PEEK Customized Cranial Implant Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jul 11, 2019 as substantially equivalent to K153248 (Stryker, 2016) after a 156-day review. Its family tree reaches back 6 generations to 1990. 1 later device descends from it.
- Decided
- Jul 11, 2019
- Review
- 156 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K904111 (1990). 12 ancestors in all, the oldest K832283 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 5 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 4 generations backK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- 3 generations backK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- 2 generations backK121153 Peek Customized Craial Implant KitStryker · 2012
- 1 generation backK153248 PEEK Customized Cranial ImplantStryker · 2016
- This deviceK190229 Stryker PEEK Customized Cranial Implant KitStryker · 2019
- Descendant · cites it directly · 0 of its ownK203055 Stryker PEEK Customized Cranial Implant KitStryker · 2021
Most influential descendants
Showing 1 of 1 · See all- K203055Stryker PEEK Customized Cranial Implant KitStryker · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −5 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −4 | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | 1 |
| −3 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| −2 | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| −1 | K153248 | PEEK Customized Cranial Implant | Stryker | 2016 | — |
| 0 (this device) | K190229 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2019 | — |
| +1 | K203055 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 GWO? 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 GWO device
- #1 K261058 CraniUS Platescore 16.8 · 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? (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 | Decided |
|---|---|---|---|
| * | K153248 | PEEK Customized Cranial ImplantSummary page 4…Preformed alterable cranioplasty plate 21 CFR §882.5320 name: Regulatory Class: Class II Product Code: GWO III. PREDICATE DEVICE Predicate: K153248, Stryker PEEK Customized Cranial Implant Kit This predicate has not been subject to a design-related recall. IV. DEVICE DESCRIP… | 2016 |
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 |
|---|---|---|---|
| K203055 | Stryker PEEK Customized Cranial Implant Kit | 2021 | 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 29 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K203055 (Stryker, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The PEEK Customized Cranial Implant Kit is indicated for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.
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/K190229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190229: Stryker PEEK Customized Cranial Implant Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190229
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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