# K003275: Synthes Synmesh Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 23, 2001 after 186 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,705 later devices descend from it; 13 cite it directly.
1 of 1,706 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020152: Synthes Vertebral Spacer TI (2002), 1,684 descendants of its own
- K024364: Synthes Vertebral Spacer TI (Curved and Narrow) (2003), 1,683 descendants of its own
- K020887: Ebi Ais Spine System (2002), 1,622 descendants of its own
- K040482: Ebi Esl Spine Spacer System (2004), 1,621 descendants of its own
- K042268: Ebi Cas Spine Spacer System (2004), 1,620 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"

Source page: https://510kreport.com/device/K003275
Methodology: https://510kreport.com/methodology