510(k) · Cleared
Recalled · Class II · 2013Stryker 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 Orthopaedics · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Oct 26, 2010 as substantially equivalent to K043250 (Stryker Leibinger, 2005) after a 14-day review. Its family tree reaches back 2 generations to 1990. 23 later devices descend from it. It has been recalled once.
- Decided
- Oct 26, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- KKY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904111 (1990). 3 ancestors in all. 23 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- 1 generation backK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- This deviceK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010
- Descendant · cites it directly · 20 of its ownK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- Descendant · 2 generations on · 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 · 3 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
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011 · cites it directly20descendants
- K121153Peek Customized Craial Implant KitStryker · 2012 · 2 generations on13descendants
- K121315Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp. · 2012 · cites it directly5descendants
- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · 3 generations on4descendants
- K143173Stryker CMF MEDPOR Customized ImplantStryker · 2015 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| −1 | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | 4 |
| 0 (this device) | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | — |
| +1 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| +2 | K121153 | Peek Customized Craial Implant Kit | Stryker | 2012 | — |
| +1 | K121315 | Stryker CMF Medpor Customized Implant | Howmedica Osteonics Corp. | 2012 | — |
| +3 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +2 | K143173 | Stryker CMF MEDPOR Customized Implant | Stryker | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 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 KKY? 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 KKY device
- #1 K211514 Longeviti PorousFit implantscore 2.0 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K043250 | Stryker Patient Specific Polymer ImplantSummary page 2…-life. The manufacturing location will change from the contract manufacturer to Stryker. Although the manufacturing process has not changed since originally described in K043250, newer versions of the commercially available software described in the original submission (Materialise software) have been inte… | 2005 |
What descends from it? (23)
See all 233 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2013 | Class II | Z-0975-2014 | Labeling Change Control | Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K111065 (Howmedica Osteonics Corp. Dba Stryker Orthopeadics, 2011) has gone furthest, with 20 descendants of its own.
- 3 other devices also cite its predicate K043250.
How does its category compare?
All KKY devicesKKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KKY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KKY
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKY
1in 2025
MAUDE reports naming product code KKY, 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 | — | 0 | 0 |
| 2008 | 1 | — | 4 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 1 | — | 1 | 17 |
| 2014 | 3 | 224 | 0 | 9 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 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/K103010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103010: Stryker Patient Specific Polymer Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103010
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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