# K253627: Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

- Pathway: 510(k) (Traditional)
- Applicant: Surgify Medical OY
- Decided: Mar 26, 2026 after 127 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K862807 (1986). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251433: Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1), Surgify Medical OY (2025) Summary page 5.

## Recalls of this device
- Apr 30, 2026 · Class II · Z-2565-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2557-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2559-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2556-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2569-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2555-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2571-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2563-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2567-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2573-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
- Apr 30, 2026 · Class II · Z-2561-2026: Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

## Indications for use
Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures.

Source page: https://510kreport.com/device/K253627
Methodology: https://510kreport.com/methodology