# K082757: Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium Fixation System

- Pathway: 510(k) (Special)
- Applicant: Bioplate, Inc.
- Decided: Oct 1, 2008 after 12 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910038 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022033: Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation System, Bioplate, Inc. (2002) Summary page 1.
- 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 2.
- K923802: Timesh Titanium Mini-Softplate/Screw, Ti-Mesh, Inc. (1992) Summary page 2.
- K973145: Timesh Titanium Mini-Softplate and Micro-Soft Plate/Screw System, Sofamor Danek USA,Inc. (1997) Summary page 2.
- 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.
- K945139: Luhr Titanium Pan Fixation System, Howmedica Corp. (1995) Summary page 2.

## Cited in the summary but kept off the family tree
- K947017: Timesh System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Recalls of this device
- Mar 31, 2010 · Not classified · Z-0143-2012: There is potential defect in seal of the sterile barrier containing the device.

## Indications for use
The sterile plate and screw kit configurations for use with the Bioplate ® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

Source page: https://510kreport.com/device/K082757
Methodology: https://510kreport.com/methodology