Plate, Cranioplasty, Preformed, Non-alterable
Neurology · 21 CFR 882.5330
Recent MDR events
824 adverse event reports on file
- ACCUSHAPE PEEKJul 17, 2026InjuryMedcad3009196021-2026-00011
- PSI SD800.526 PEEK IMPLANTJul 7, 2026MalfunctionSynthes Gmbh8030965-2026-06850
- HTR-PEKKJun 29, 2026InjuryOxford Performance Materials, Inc.3009582362-2026-00003
- ACCUSHAPE TITANIUMMay 22, 2026MalfunctionMedcad3009196021-2026-00010
- CRANIOFIX 2 APPLYING FORCEPS NON-DETACHApr 24, 2026InjuryAesculap Ag9610612-2026-00099
- ACCUSHAPE PEEKApr 17, 2026MalfunctionMedcad3009196021-2026-00009
- PSI SD800.539 PEEK IMPLANTMar 5, 2026MalfunctionSynthes Gmbh8030965-2026-02247
- ACCUSHAPE PEEKMar 3, 2026MalfunctionMedcad3009196021-2026-00005
- ACCUSHAPE PEEKFeb 3, 2026InjuryMedcad3009196021-2026-00002
- ACCUSHAPE PEEKSep 24, 2025InjuryMedcad3009196021-2025-00017
Event type breakdown
Recalls
11 recall events for this product code
- Synthes (USA) Products LLCTerminatedSep 23, 2015
Synthes Cranial Flap Tube Clamp and Crimping Device
The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols currently required to designate them as MR Safe.
Z-2811-2015 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Z-0393-2019 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Z-0394-2019 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Z-0395-2019 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
Biomet Microfixation RapidFlap System
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Z-0396-2019 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
Biomet Microfixation RapidFlap System
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Z-0397-2019 · View FDA record ↗ - Zimmer Biomet, Inc.TerminatedUnknown
Biomet Microfixation RapidFlap System
Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
Z-0398-2019 · View FDA record ↗ - Kelyniam Global, Inc.TerminatedUnknown
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
Z-1870-2018 · View FDA record ↗ - Kelyniam Global, Inc.TerminatedUnknown
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
Z-1871-2018 · View FDA record ↗ - Kelyniam Global, Inc.TerminatedUnknown
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
Z-1872-2018 · View FDA record ↗
Registered firms
87 firms currently registered for this product code
Kls-martin L.p.
Jacksonville, FL, US
Biomet Microfixation
Jacksonville, FL, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Kelyniam Global Inc.
COLLINSVILLE, CT, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Kontour (xi'an) Medical Technology Co., Ltd.
Xi'an Shaanxi, CN
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Kls Martin Se & Co. Kg
Muhlheim/Donau Baden-Wurttemberg, DE
Oxford Performance Materials, Inc.
South Windsor, CT, US
Microware Precision Co., Ltd.
Taichung, TW
Synthes (usa) Products Llc
West Chester, PA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Osteomed
ADDISON, TX, US
Fin-ceramica Faenza Spa
faenza Ravenna, IT
Synthes Gmbh
Zuchwil Solothurn, CH
Bioplate, Inc.
Placentia, CA, US
3d Medical Applications Center (3d Mac)
Bethesda, MD, US
510(k) clearances
57 clearances for this product code
- Longeviti Neuro SolutionsJun 25, 2026
K260709 · ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)
- The Surgeon General, Department of the Army (TSG-DA)Jun 18, 2026
K253116 · 3D MAC Titanium Cranial Plate (TCP) System
- CG Bio Co., Ltd.Apr 9, 2026
K252251 · EASYMADE-TI
- Meticuly Co., Ltd.Jan 14, 2026
K252958 · METICULY Patient-specific titanium mesh implant
- Synthes GmbHNov 12, 2025
K243715 · Synthes Patient Specific Implants
- KLS-Martin L.P.Nov 10, 2025
K252573 · KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
- Fin-Ceramica Faenza S.P.A.Mar 28, 2024
K240567 · CustomizedBone Service
- Longeviti Neuro Solutions, LLCNov 9, 2023
K231920 · Longeviti ClearFit OTS Cranial Implant