# K023665: Modification to Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Nov 22, 2002 after 22 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910038 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943071: The Titanium Fixation System, Biomedics (1995) Summary page 1.
- K992330: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery, Biomedics (1999) Summary page 1.
- K923419: Tismesh System, Ti-Mesh, Inc. (1993) Summary page 1.
- K923802: Timesh Titanium Mini-Softplate/Screw, Ti-Mesh, Inc. (1992) Summary page 1.
- K973145: Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K921801: Modification Techmedica MP (Miniplating) System, Techmedica, Inc. (1992) Summary page 2.
- K910038: Lorenz Ultra-Micro Titanium Osteosynthesis System, Walter Lorenz Surgical, Inc. (1991) Summary page 2.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 2.
- K944565: KLS-Martin Micro Osteosythesis System (1.5MM), KLS-Martin L.P. (1994). Our reading of the summary gave K944545, FDA’s number for Body Fluids Barrier Kit (Ani Safety, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “KLS-Martin Micro Osteosynthesis System (1.5mm)”.
- K943347: KLS Mini Osteosynthesis System, Patton, Boggs & Blow (1994) Summary page 2.
- K974017: Timesh System, Sofamor Danek USA,Inc. (1998) Summary page 2.
- K945139: Luhr Titanium Pan Fixation System, Howmedica Corp. (1995) Summary page 2.

## Indications for use
The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K023665
Methodology: https://510kreport.com/methodology