# K121253: Meridian Cranial Perforator

- Pathway: 510(k) (Traditional)
- Applicant: Adeor Medical Technologies GmbH
- Decided: Jul 17, 2012 after 83 days
- Product code: HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4305
- 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 K791101 (1979). 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)
- K933894: Disposable Perforator, Codman & Shurtleff, Inc. (1993) Summary page 2.
- K071931: Codman Disposable Perforator, Model (S) 26-1222, 26-1223, Codman & Shurtleff, Inc. (2007) Summary page 2.
- K833266: Acra-Cut, Acra Cut, Inc. (1983) Summary page 2.
- (no number) Acra-Cut DGR-1 and DGR-11: named in the summary without a submission number
- (no number) Codman 26-1221: named in the summary without a submission number

## Indications for use
The MeridianTM Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian"m pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm. Pediatric: for bone thickness of at least 1.5 mm: For bone thickness of at least 3.0 mm: PER 6-9-SP IPER 6-9-S PER 7-11 -SP PER 7-11 -S PER 11-14-SP PER 11-14-S

Source page: https://510kreport.com/device/K121253
Methodology: https://510kreport.com/methodology