510(k) · Cleared
Recalled · 2008Stryker Patient Specific Polymer Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Leibinger · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Apr 15, 2005 as substantially equivalent to K924935 (Polyclinic Medical Center, 1993) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 1990. 50 later devices descend from it. It has been recalled 4 times.
- Decided
- Apr 15, 2005
- Review
- 143 days
- Class
- Class II
- Product code
- KKY
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904111 (1990). 2 ancestors in all. 50 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- This deviceK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005
- Descendant · cites it directly · 23 of its ownK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- Descendant · 2 generations on · 20 of its ownK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- Descendant · cites it directly · 20 of its ownK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- Descendant · cites it directly · 18 of its ownK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- Descendant · 2 generations on · 17 of its ownK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K103010Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · cites it directly23descendants
- K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011 · 2 generations on20descendants
- K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007 · cites it directly20descendants
- K052871Stryker Custom TI ImplantStryker Leibinger · 2005 · cites it directly18descendants
- K062570Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904111 | HTR Polymer, HTR-MX | United States Surgical, A Division of Tyco Healthc | 1990 | — |
| 0 (this device) | K043250 | Stryker Patient Specific Polymer Implant | Stryker Leibinger | 2005 | — |
| +1 | K103010 | Stryker Patient Specific Polymer Implant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | 1 |
| +2 | K111065 | Stryker (R) Patient Specific Polymer Implant | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011 | — |
| +1 | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| +1 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| +2 | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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? (4)
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 |
|---|---|---|---|
| * | K924935 | Hard Tissue Replace (HTR (R))-Patient-Match ImplantSummary page 1…l Equivalency Information The Stryker® Patient Specific Polymer Implant is substantially equivalent to the Hard Tissue Replacement - Patient Match Implant K924935, Hard Tissue Replacement -- Malleable Facial Implant, Hard Tissue Replacement-MX K9041 11, Surgical Simplex P Radio… | 1993 |
| * | K904111 | HTR Polymer, HTR-MXSummary page 1…equivalent to the Hard Tissue Replacement - Patient Match Implant K924935, Hard Tissue Replacement -- Malleable Facial Implant, Hard Tissue Replacement-MX K9041 11, Surgical Simplex P Radiopaque Bone Cement (Howmedica Osteonics N-17-004). The Stryker® Patient Specific Polymer I… | 1990 |
| * | — | Hard Tissue Replacement - Malleable Facial Implant Named without a submission number | |
| * | — | Surgical Simplex P Radiopaque Bone Cement Named without a submission number |
What descends from it? (50)
See all 504 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 |
|---|---|---|---|---|
| Oct 24, 2008 | Not classified | Z-0510-2009 | Process control | Lack of assurance of sterility. |
| Oct 24, 2008 | Not classified | Z-0512-2009 | Process control | Lack of assurance of sterility. |
| Oct 24, 2008 | Not classified | Z-0509-2009 | Process control | Lack of assurance of sterility. |
| Oct 24, 2008 | Not classified | Z-0511-2009 | Process control | Lack of assurance of sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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 madibular, maxillofacial, or craniofacial bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043250: Stryker Patient Specific Polymer Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043250
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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