# K022033: Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation System

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Jul 19, 2002 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972322: Lorenz 1.5 MM Neuro Pack/Lorenz 2.0 FT Plates, Walter Lorenz Surgical, Inc. (1997) 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 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.

## Most influential descendants
- K082757: Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium Fixation System (2008), 0 descendants of its own

## Indications for use
The sterile plate and screw kit configurations for use with the BioplateB Titanium Fixation System are intended for use in non-load bearing fixation, including cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacialskeleton and. Each device is intended for single use only, and only in conjunctionwith other titanium and titanium alloy implants.

Source page: https://510kreport.com/device/K022033
Methodology: https://510kreport.com/methodology