# K021684: The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery

- Pathway: 510(k) (Traditional)
- Applicant: Bioplate, Inc.
- Decided: Jun 26, 2002 after 35 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 K854886 (1986). 12 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854886: Wuerzburg Titanium Mini Bone Plates & Bone Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 1.
- K912932: Synthes Maxillofacial Titanium Micro Set, Synthes (Usa) (1991) 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 1.
- K910038: Lorenz Ultra-Micro Titanium Osteosynthesis System, Walter Lorenz Surgical, Inc. (1991) Summary page 1.
- K944561: Micro Osteosynthesis System (1.0), KLS-Martin L.P. (1994) Summary page 1.
- 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.

## Most influential descendants
- K062819: Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery (2006), 3 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- K023810: Modification to Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery (2002), 1 descendant of its own
- K121606: Resorb-X G (2013), 0 descendants of its own
- K101835: Medpor Fixation System-Cranial, Models 80080, 80079 (2010), 0 descendants of its own

## 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/K021684
Methodology: https://510kreport.com/methodology