510(k) · Cleared
ClearedStryker (R) Patient Specific Polymer Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. Dba Stryker Orthopeadics · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jul 14, 2011 as substantially equivalent to K103010 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2010) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 1990. 20 later devices descend from it.
- Decided
- Jul 14, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904111 (1990). 6 ancestors in all. 20 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 2 generations backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- 1 generation backK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- This deviceK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- Descendant · cites it directly · 13 of its ownK121153 Peek Customized Craial Implant KitStryker · 2012
- Descendant · cites it directly · 5 of its ownK121315 Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp. · 2012
- Descendant · 2 generations on · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- Descendant · 2 generations on · 4 of its ownK143173 Stryker CMF MEDPOR Customized ImplantStryker · 2015
- Descendant · 2 generations on · 3 of its ownK132519 Stryker Customized Mandible Recon Plate KitStryker · 2013
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K121153Peek Customized Craial Implant KitStryker · 2012 · cites it directly13descendants
- K121315Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp. · 2012 · cites it directly5descendants
- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · 2 generations on4descendants
- K143173Stryker CMF MEDPOR Customized ImplantStryker · 2015 · 2 generations on4descendants
- K132519Stryker Customized Mandible Recon Plate KitStryker · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −2 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| −1 | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | 1 |
| 0 (this device) | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| +1 | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| +1 | K121315 | Stryker CMF Medpor Customized Implant | Howmedica Osteonics Corp. | 2012 | — |
| +2 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +2 | K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015 | — |
| +2 | K132519 | Stryker Customized Mandible Recon Plate Kit | Stryker | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 16.9 · 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 |
|---|---|---|---|
| * | K103010 | Stryker Patient Specific Polymer ImplantSummary page 1…ct will now be supplied with an online ordering system called eRequest Lifecycle. The manufacturing location and processes have not changed since originally described in K103010. Device Description: The Strykero Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement th… | 2010 |
| * | K083621 | Medpor Customized Surgical ImplantSummary page 2…ally equivalent with predicate devices such as the 51 0(k) clearance of: * Strylker® Patient Specific Polymer Implant (K103010) * MEDPOR Customized Surgical Implant (K083621) The following matrix demonstrates the substantially equivalence of the Stryker@ Patient Specific Polymer Implant with the two… | 2009 |
What descends from it? (20)
See all 202 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 21 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K121153 (Stryker, 2012) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K103010.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111065: Stryker (R) Patient Specific Polymer Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111065
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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