# K052041: Collagen Bone Healing Protective Sheet

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Oct 25, 2005 after 89 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: 3 generations back to K974017 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011695: Collagen Dental Membrane, Collagen Matrix, Inc. (2001)
- K960724: Bio-Gide Resorbable Bilayer Membrane, Geistlich-Pharma (1997) Summary page 1.
- K033918: Ebi Lactosorb Graft Containment System, Ebi, L.P. (2004) Summary page 1.
- K994158: Macrosorbos Protective Sheet, Macropore Biosurgery, Inc. (2000) Summary page 1.

## Indications for use
The Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: * Long bones * Flat bones * Short bones * Irregular bones - Appendicular skeleton * Thorax When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: * Tumor resections where bone strength has not been compromised * Iliac crest harvests This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Source page: https://510kreport.com/device/K052041
Methodology: https://510kreport.com/methodology