510(k) · Cleared
ClearedPeek Customized Craial 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 Sep 14, 2012 as substantially equivalent to K053199 (Synthes (Usa), 2005) and 1 other predicate after a 151-day review. Its family tree reaches back 4 generations to 1990. 13 later devices descend from it.
- Decided
- Sep 14, 2012
- Review
- 151 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904111 (1990). 10 ancestors in all, the oldest K832283 (1984). 13 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 3 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 2 generations backK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- 1 generation backK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- This deviceK121153 Peek Customized Craial Implant KitStryker · 2012
- Descendant · cites it directly · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK132519 Stryker Customized Mandible Recon Plate KitStryker · 2013
- Descendant · cites it directly · 2 of its ownK153248 PEEK Customized Cranial ImplantStryker · 2016
- Descendant · 2 generations on · 1 of its ownK261058 CraniUS PlateCraniUS, LLC · 2026
- Descendant · 2 generations on · 1 of its ownK193136 Stryker Customized Mandible Recon Plate KitStryker · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · cites it directly4descendants
- K132519Stryker Customized Mandible Recon Plate KitStryker · 2013 · cites it directly3descendants
- K153248PEEK Customized Cranial ImplantStryker · 2016 · cites it directly2descendants
- K261058CraniUS PlateCraniUS, LLC · 2026 · 2 generations on1descendant
- K193136Stryker Customized Mandible Recon Plate KitStryker · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −3 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −2 | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | 1 |
| −1 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| 0 (this device) | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| +1 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +1 | K132519 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2013 | — |
| +1 | K153248 | PEEK Customized Cranial Implant | Stryker | 2016 | — |
| +2 | K261058 | CraniUS Plate | CraniUS, LLC | 2026 | — |
| +2 | K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2020 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 3…wing technical characteristics: - Material: The PEEK Customized Cranial Implant and the Synthes Patient Specific Cranial/Craniofacial Implant - K053199 are made of the identical medical grade PEEK Optima LTI from the same supplier, Invibio - Design: The PEEK Cu… | 2005 |
| * | K111065 | Stryker (R) Patient Specific Polymer ImplantSummary page 3…terile to the user * Case initiation and data exchange: The PEEK Customized Cranial Implant and the Stryker Patient Specific Polymer Implant - K 111065 use identical systems PEEK Customized CranialImplant Kit Traditional51… | 2011 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K182711 (Kelyniam Global, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K053199.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 filling bony voids in the cranial and craniofacial skeleton in patients 12 years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121153: Peek Customized Craial 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/K121153
Report an extraction error
Are you the manufacturer?
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