# K191463: DePuy Synthes Hammertoe Continuous Compression Implant

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Feb 26, 2020 after 268 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960385 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 4.
- K133520: Hammerlock 2, Biomedical Enterprises, Inc. (2014) Summary page 4.

## Recalls of this device
- Sep 27, 2022 · Class II · Z-0101-2023: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the inco
- Aug 30, 2022 · Class II · Z-0008-2023: Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is requir

## Indications for use
The DePuy Synthes Hammertoe Continuous Compression Implant is indicated for small bone reconstruction and fusion of the phalanges in the toes.

Source page: https://510kreport.com/device/K191463
Methodology: https://510kreport.com/methodology