# K970851: Lyoplant Dura Substitute (Various)

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Dec 9, 1997 after 277 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dura-Guard™ Dural Repair Patch: named in the summary without a submission number
- (no number) Peri-Guard® Pericardium: named in the summary without a submission number
- (no number) Neuro-Patch Dura Substitute: named in the summary without a submission number
- (no number) Preclude Dura Substitute: named in the summary without a submission number
- (no number) Dura Film: named in the summary without a submission number
- (no number) Tutoplast® Dura substitute: named in the summary without a submission number

## Most influential descendants
- K982180: Duragen Dural Graft Matrix (1999), 30 descendants of its own
- K032693: Duragen Plus Dural Graft Matrix (2003), 9 descendants of its own
- K041000: Durepair Dura Regeneration Matrix (2004), 7 descendants of its own
- K052211: Durepair Dura Regeneration Matrix (2005), 5 descendants of its own
- K063117: Modification to Durepair Dura Regeneration Matrix (2006), 3 descendants of its own

## Indications for use
Lyoplant Dura Substitute presented in this submission is intended as a dura mater substitute in neurological procedures for soft tissue reconstruction of damaged, impaired, or missing tissue.

Source page: https://510kreport.com/device/K970851
Methodology: https://510kreport.com/methodology