# K173693: Orbitum Bone Staple Implant, X and VI

- Pathway: 510(k) (Traditional)
- Applicant: Orthovestments, LLC
- Decided: Feb 23, 2018 after 84 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961522 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043059: Compression Staple and Simple Staple, Wrightmedicaltechnologyinc (2005) Summary page 4.
- K121277: Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple, Z-Medical GmbH & Co. KG (2012) Summary page 4.
- K161587: Memodyn Staple, Austin & Associates, Inc./Telos Medical Equipment (2017) Summary page 4.

## Indications for use
The ORBITUM X and VI Bone Staple is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Orbitum X and VI implants are intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis Akin osteotomy, midfoot and hindfoot arthrodesis or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Source page: https://510kreport.com/device/K173693
Methodology: https://510kreport.com/methodology