# K943540: Surgical Cutting Burs

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Nov 30, 1994 after 131 days
- Product code: DZJ (Driver, Wire, And Bone Drill, Manual)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
254 later devices descend from it; 5 cite it directly.
0 of 255 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991696: Stryker Hermes-Ready Total Performance System (1999), 253 descendants of its own
- K032117: Stryker Total Performance (TPS) System (2003), 238 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## Recalls of this device
- Oct 2, 2013 · Class II · Z-0092-2014: It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier t

Source page: https://510kreport.com/device/K943540
Methodology: https://510kreport.com/methodology