# K221697: Injection Pin (Kip (02031-02061) (03031-03061))

- Pathway: 510(k) (Traditional)
- Applicant: Slk Ortho, LLC
- Decided: Mar 3, 2023 after 266 days
- Product code: NDN (Cement, Bone, Vertebroplasty)
- Device class: 2
- Regulation: 21 CFR 888.3027
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K970097 (1997). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191709: V-STRUT Vertebral Implant, Hyprevention Sas (2020) Summary page 4.

## Indications for use
The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F20®) for the treatment of fractures caused by trauma, osteoporosis, or tumors in the thoracic/lumbar spine from T9-L5.

Source page: https://510kreport.com/device/K221697
Methodology: https://510kreport.com/methodology