# K033652: Minimally Invasive Solutions Osteotomy Guide Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 4, 2004 after 76 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991218 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031371: Saphyre Bipolar Ablation Probes, Smith & Nephew, Inc. (2003) Summary page 1.

## Indications for use
This device is intended for local coagulation of soft tissues during minimally invasive orthopedic surgeries, such as, but not limited to hip, knee, shoulder and elbow arthroplasty by use of high-frequency electrical current. This local coagulation serves to mark the tissue to aid the surgeon in the location of subsequent osteotomies.

Source page: https://510kreport.com/device/K033652
Methodology: https://510kreport.com/methodology