# K022370: Framelock; Framelock Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Oct 18, 2002 after 88 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904283 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904283: PS Medical Cranial Hand Drill, Pudenz-Schulte Medical Research Corp. (1990) Summary page 2.

## Most influential descendants
- K051734: GE Healthcare Insta Trak 3500PLUS/ Fluoro Trak 9800 Plus System with Axcess Bone Pin, Model Part # 1006955 (2005), 0 descendants of its own

## Indications for use
The FrameLock™ is indicated for otorhinolaryngological and head/neck surgery where any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomic head or neck structure, such as the skull, vertebrae, intranasal area, or sinus, can be identified relative to a CT or MR based model of the anatomy.

Source page: https://510kreport.com/device/K022370
Methodology: https://510kreport.com/methodology