510(k) · Cleared
ClearedPatient Contoured Mesh (PCM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · GXN Plate, Cranioplasty, Preformed, Non-Alterable
Cleared on Oct 31, 2006 as substantially equivalent to K052871 (Stryker Leibinger, 2005) and 2 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1990. 17 later devices descend from it.
- Decided
- Oct 31, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- GXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K904111 (1990). 7 ancestors in all, the oldest K832283 (1984). 17 later devices descend from it, 4 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 backK052871 Stryker Custom TI ImplantStryker Leibinger · 2005
- This deviceK062570 Patient Contoured Mesh (PCM)KLS-Martin L.P. · 2006
- Descendant · cites it directly · 13 of its ownK072707 Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007
- Descendant · 2 generations on · 8 of its ownK103582 Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 5 of its ownK121755 Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK182711 Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK161090 Cranial PSIOssdsign AB · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K072707Patient Contoured Mesh-Peek (PCM-P)KLS-Martin L.P. · 2007 · cites it directly13descendants
- K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc. · 2011 · 2 generations on8descendants
- K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc. · 2012 · 2 generations on5descendants
- K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc. · 2019 · 3 generations on4descendants
- K161090Cranial PSIOssdsign AB · 2017 · cites it directly2descendants
View 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 | K052871 | Stryker Custom TI Implant | Stryker Leibinger | 2005 | — |
| 0 (this device) | K062570 | Patient Contoured Mesh (PCM) | KLS-Martin L.P. | 2006 | — |
| +1 | K072707 | Patient Contoured Mesh-Peek (PCM-P) | KLS-Martin L.P. | 2007 | — |
| +2 | K103582 | Kelyniam Custom Skull Implant (Csi) | Kelyniam Global, Inc. | 2011 | 4 |
| +2 | K121755 | Custom Craniofacial Implant (Cci) | Kelyniam Global, Inc. | 2012 | — |
| +3 | K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | 2019 | — |
| +1 | K161090 | Cranial PSI | Ossdsign AB | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K052871 | Stryker Custom TI ImplantSummary page 1…Plate, Cranioplasty, Preformed, Non-Alterable (CFR 882.5330) Regulatory Class: II Predicate Devices: Stryker Custom TI Implant (K052871) Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199)… | 2005 |
| * | K053199 | Synthes Patient Specific Cranial/Craniofacial ImplantSummary page 1…dicate Devices: Stryker Custom TI Implant (K052871) Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)… | 2005 |
| * | K033868 | Synthes (Usa) Patient Specific Cranial/Craniofacial ImplantsSummary page 1…iofacial Implant (PSCI) (K053199) Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) KLS-Martin Micro Osteosynthesis System (1.5 mm) (K944565)… | 2004 |
What descends from it? (17)
See all 174 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K072707 (KLS-Martin L.P., 2007) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K052871.
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.
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?
Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062570 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062570: Patient Contoured Mesh (PCM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062570
Report an extraction error
Are you the manufacturer?
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