# K983360: Macropore Protective Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Materials and Interfaces
- Decided: Mar 19, 1999 after 176 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 K862532 (1986). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862532: Dumbach Titanium Mesh Implant System, Walter Lorenz Surgical, Inc. (1986) Summary page 4.
- K980927: Lactosorb Panels and Fasteners, Biomet, Inc. (1998) Summary page 4.
- K963394: Osteomed Tram, Osteomed Corp. (1996) Summary page 4.

## Most influential descendants
- K011569: Biosorbfx O/M 2.0/2/4 System (2002), 5 descendants of its own
- K061881: Osteotrans -MX Bioabsorbable Bone Fixation System (2007), 3 descendants of its own
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants 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
MacroPore Protective Sheet is intended to facilitate healing in trauma, reconstruction and bone augmentation procedures of the mandible. The following specific indications are included: = to maintain the relative position of bony fragments in trauma and bone graft procedures, and « to contain and prevent migration and shifting of autograft, allograft and/or bone graft substitutes that may be necessary in reconstructive procedures. The system is not intended for full load bearing procedures unless supplemental fixation intended for such procedures is used.

Source page: https://510kreport.com/device/K983360
Methodology: https://510kreport.com/methodology