# K983766: Synthes Synmesh

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Dec 18, 1998 after 53 days
- Product code: EZX (Mesh, Surgical, Metal)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900138 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900138: Motech Titanium Surgical Mesh, Biedermann Motech GmbH (1990) Summary page 1.

## Most influential descendants
- K020853: Nuvasive Mesh (2002), 0 descendants of its own

## Recalls of this device
- Sep 21, 2020 · Class III · Z-0408-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0412-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0416-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0407-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0409-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0411-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0413-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0414-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0403-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0404-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0405-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0406-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0410-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
- Sep 21, 2020 · Class III · Z-0415-2021: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

## Indications for use
Indication for use is for the reinforcement of weak bony tissue in orthopedic procedures.

Source page: https://510kreport.com/device/K983766
Methodology: https://510kreport.com/methodology