# K011698: Straumann GBR System

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Aug 23, 2001 after 83 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: 2 generations back to K952167 (1995). 3 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960914: 3I Osseous Fixation System (S), Implant Innovations, Inc. (1996) Summary page 1.
- K955369: Memfix, The Straumann Co. (1996) Summary page 1.
- (no number) Leibinger Bone Grafting System: named in the summary without a submission number
- (no number) Leibinger M-TAM: named in the summary without a submission number
- (no number) TiMesh titanium mesh cribs: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System, Elekta Instruments, Inc. (1995). Our OCR of the scanned summary read K946165, FDA’s number for CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation… (Elekta Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MODUS® System Plates, Mesh, and Screws”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own
- K063769: Alpha Bio Bone Fixation Screw System (2007), 4 descendants of its own
- K141764: Tristar Bone Graft Fixation System (2014), 3 descendants of its own
- K170697: GBR system (2018), 2 descendants of its own
- K143730: GBR System (2015), 2 descendants of its own

## Indications for use
The Straumann Guided Bone Regeneration (GBR) System is used to stabilize and fixate bone grafts, bone filling materials, and/or barrier membranes used for regeneration of bone in the oral cavity. The GBR technique can make it possible for the placement of dental implants in previously unsuitable sites.

Source page: https://510kreport.com/device/K011698
Methodology: https://510kreport.com/methodology