510(k) · Cleared
ClearedHTR Polymer, HTR-MX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Nov 23, 1990 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 52 later devices descend from it.
- Decided
- Nov 23, 1990
- Review
- 78 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 0
52 later devices descend from it, 2 citing it directly.
- This deviceK904111 HTR Polymer, HTR-MXUnited States Surgical, A Division of Tyco Healthc · 1990
- Descendant · cites it directly · 50 of its ownK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
- Descendant · 2 generations on · 23 of its ownK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
- Descendant · 3 generations on · 20 of its ownK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
- Descendant · 2 generations on · 20 of its ownK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- Descendant · 2 generations on · 18 of its ownK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K043250Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · cites it directly50descendants
- K103010Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · 2 generations on23descendants
- K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011 · 3 generations on20descendants
- K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007 · 2 generations on20descendants
- K052871Stryker Custom TI ImplantStryker Leibinger · 2005 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | 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 | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| +2 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 2 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (52)
See all 522 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?
- Of its descendants, K043250 (Stryker Leibinger, 2005) has gone furthest, with 50 descendants of its own.
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 | — |
https://510kreport.com/device/K904111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904111: HTR Polymer, HTR-MX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904111
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026