510(k) · Cleared
ClearedOsteosymbionics Patient Specific Cranial Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteosymbionics, LLC · GXP Methyl Methacrylate For Cranioplasty
Cleared on Dec 10, 2007 as substantially equivalent to K033868 (Synthes (Usa), 2004) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1990. 20 later devices descend from it.
- Decided
- Dec 10, 2007
- Review
- 87 days
- Class
- Class II
- Product code
- GXP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K904111 (1990). 5 ancestors in all, the oldest K873689 (1987). 20 later devices descend from it, 6 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 deviceK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
- Descendant · cites it directly · 11 of its ownK110684 Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial…Vanduzen Dba Medcad · 2011
- Descendant · cites it directly · 8 of its ownK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- Descendant · cites it directly · 5 of its ownK133082 Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC · 2014
- Descendant · 2 generations on · 5 of its ownK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K110684Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial ImplantVanduzen Dba Medcad · 2011 · cites it directly11descendants
- K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · cites it directly8descendants
- K133082Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC · 2014 · cites it directly5descendants
- K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012 · 2 generations on5descendants
- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · 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) | K072601 | Osteosymbionics Patient Specific Cranial Implant | Osteosymbionics, LLC | 2007 | — |
| +1 | K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant | Vanduzen Dba Medcad | 2011 | — |
| +1 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| +1 | K133082 | Osteosymbionics Patient-Specific Cranial Plate | Osteosymbionics, LLC | 2014 | — |
| +2 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
| +2 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 GXP? 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 GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 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 |
|---|---|---|---|
| * | K033868 | Synthes (Usa) Patient Specific Cranial/Craniofacial ImplantsSummary page 1…marketed devices: r ~~~~~~~~Synthes Patient Specific Cranial/Craniofacial Implants - K033868 C0 Synthes (USA) 2 Stryker® lPatient.Specific Polymer Implant - K04325… | 2004 |
| * | K043250 | Stryker Patient Specific Polymer ImplantSummary page 1…ecific Cranial/Craniofacial Implants - K033868 C0 Synthes (USA) 2 Stryker® lPatient.Specific Polymer Implant - K043250 0 Stryker Liebinger Codman Cranioplastic - K873689 C… | 2005 |
| * | K873689 | Cranioplastic, Acrylic Cranioplasty MaterialSummary page 1…Stryker® lPatient.Specific Polymer Implant - K043250 0 Stryker Liebinger Codman Cranioplastic - K873689 C Codman Division of]Johnson & Johnson 1768 East 25th Street Cleveland, OH 44114-4420 fa… | 1987 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110684 | Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial Implant | 2011 | 11 |
| K103582 | Kelyniam Custom Skull Implant (Csi) | 2011 | 8 |
| K133082 | Osteosymbionics Patient-Specific Cranial Plate | 2014 | 5 |
| K170410 | Longeviti PMMA Static Cranial Implant | 2018 | 4 |
| K121102 | Osteosymbionics Peek Cranial Implant | 2012 | 2 |
| 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 17 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K110684 (Vanduzen Dba Medcad, 2011) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K033868.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, 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 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
The OsteoSymbionics Patient Specific Cranial Implants are designed individually for each patient to correct defects in craniofacial bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072601: Osteosymbionics Patient Specific Cranial Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072601
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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