510(k) · Cleared
ClearedOsteosymbionics Peek Cranial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteosymbionics, LLC · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Aug 8, 2012 as substantially equivalent to K072601 (Osteosymbionics, LLC, 2007) and 2 other predicates after a 119-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 8, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904111 (1990). 8 ancestors in all, the oldest K832283 (1984). 2 later devices descend from it, 1 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 backK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- This deviceK121102 Osteosymbionics Peek Cranial ImplantOsteosymbionics, LLC · 2012
- Descendant · cites it directly · 1 of its ownK121818 Osteofab Patient Specific Cranial DeviceOxford Performance Materials · 2013
- Descendant · 2 generations on · 0 of its ownK180064 OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView 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 | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| 0 (this device) | K121102 | Osteosymbionics Peek Cranial Implant | Osteosymbionics, LLC | 2012 | — |
| +1 | K121818 | Osteofab Patient Specific Cranial Device | Oxford Performance Materials | 2013 | — |
| +2 | K180064 | OsteoFab Patient Specific Cranial Device | Oxford Performance Materials, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2018 | 1 | 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 GXN? 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 GXN device
- #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 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? (3)
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 |
|---|---|---|---|
| * | K072601 | Osteosymbionics Patient Specific Cranial ImplantSummary page 1…NT TO: The OsteoSymbionics PEEK Patient Specific Cranial Implants are substantially equivalent to: 1) OsteoSymbionics Patient Specific Cranial Implants made from PMMA (K#072601) and 2) Synthes (USA) Patient Specific Cranial/Craniofacial Implants made from PEEK (K#053199 and K#033868). Device… | 2007 |
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 1…to: 1) OsteoSymbionics Patient Specific Cranial Implants made from PMMA (K#072601) and 2) Synthes (USA) Patient Specific Cranial/Craniofacial Implants made from PEEK (K#053199 and K#033868). Device OsteoSym bionics Synthes OsteoSym bionics Characteristics PMMA… | 2005 |
| * | K033868 | Synthes (Usa) Patient Specific Cranial/Craniofacial ImplantsSummary page 1…Symbionics Patient Specific Cranial Implants made from PMMA (K#072601) and 2) Synthes (USA) Patient Specific Cranial/Craniofacial Implants made from PEEK (K#053199 and K#033868). Device OsteoSym bionics Synthes OsteoSym bionics Characteristics PMMA… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121818 | Osteofab Patient Specific Cranial Device | 2013 | 1 |
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 3 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K121818 (Oxford Performance Materials, 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K072601.
How does its category compare?
All GXN devicesGXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GXN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXN
69in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXN
24in 2025
MAUDE reports naming product code GXN, 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 | 2 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 17 |
| 2010 | 0 | — | 0 | 23 |
| 2011 | 2 | — | 0 | 20 |
| 2012 | 3 | 102 | 0 | 29 |
| 2013 | 1 | — | 0 | 57 |
| 2014 | 2 | — | 0 | 60 |
| 2015 | 2 | — | 0 | 47 |
| 2016 | 1 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 74 |
| 2018 | 3 | 199 | 6 | 56 |
| 2019 | 0 | — | 0 | 54 |
| 2020 | 5 | 33 | 0 | 63 |
| 2021 | 3 | 69 | 0 | 63 |
| 2022 | 2 | — | 0 | 57 |
| 2023 | 1 | — | 0 | 32 |
| 2024 | 1 | — | 0 | 35 |
| 2025 | 2 | — | 0 | 24 |
| 2026 | 4 | 193 | 0 | — |
What is it indicated for?
OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121102: Osteosymbionics Peek Cranial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121102
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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