# K972913: Macropore Protective Sheet (Protego System)

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Materials and Interfaces
- Decided: Jul 30, 1998 after 357 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K900138 (1990). 4 ancestors in all.
84 later devices descend from it; 5 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960988: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 3.
- K955729: Lactosorb Trauma Plating System, Poly-Medics,Inc. (1996) Summary page 3.
- K922308: Tilghman Titanium Mesh Skeletal Orbit Liner, Ti-Mesh, Inc. (1993) Summary page 3.
- K900138: Motech Titanium Surgical Mesh, Biedermann Motech GmbH (1990) Summary page 3.
- (no number) Leibinger Titanium DynamicMesh: named in the summary without a submission number

## Most influential descendants
- K993061: Stryker Leibinger Resorbable Fixation System (1999), 79 descendants of its own
- K011590: Resorb-X Resorbable Plating System (2002), 73 descendants of its own
- K060177: KLS Martin Rigid Fixation  - Sterile (2006), 65 descendants of its own
- K070169: KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile (2007), 61 descendants of its own
- K151983: KLS Martin LSS Plating System (2016), 45 descendants of its own

## Indications for use
MacroPore Protective Sheet (MPS) is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton: 1. Comminuted fractures of the naso-ethmoidal and infraorbital areas 2. Comminuted fractures of the frontal sinus wall 3. Trauma of the midface or craniofacial skeleton 4. Reconstructive procedures of the midface or craniofacial skeleton. The system is not intended for use in the mandible and/or for full load bearing procedures.

Source page: https://510kreport.com/device/K972913
Methodology: https://510kreport.com/methodology