# K970841: Imtec/Titanium Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Apr 30, 1997 after 54 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 K862482 (1986). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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 1.
- K963394: Osteomed Tram, Osteomed Corp. (1996) Summary page 1.
- K862482: Steinhauser Titanium Mini Bone Plates & Screws, Walter Lorenz Surgical, Inc. (1986) Summary page 1.
- K923419: Tismesh System, Ti-Mesh, Inc. (1993). Our OCR of the scanned summary read K923491, FDA’s number for Bte Hearing Aid Personic 425 (Oticon Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “TiMesh Inc., Reconstructive Surgery System”.

## Most influential descendants
- K091120: Medpor Contain Implant (2010), 1 descendant of its own
- K102184: Medpor Contain Can Implant (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K970841
Methodology: https://510kreport.com/methodology