# K132373: Biomet Access System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine (Aka Ebi, LLC)
- Decided: Mar 27, 2014 after 240 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K923056 (1992). 19 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,, Cadwell Lab, Inc. (2011) Summary page 1.
- K123589: Cadwell Disposable Probe Handle, Cadwell (2013) Summary page 1.
- K110419: Avs Aria Neuromonitoring Probe and Avs Aria Probe Dilators, Stryker Spine (2011)
- K112709: Stimulation/Dissection Instruments, Nu Vasive, Incorporated (2012) Summary page 1.

## Most influential descendants
- K142438: Nerve Monitoring Cable System (2015), 4 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own
- K191723: ATEC IOM Accessory Instruments (2019), 2 descendants of its own
- K221821: ATEC IOM Accessory Instruments (2022), 1 descendant of its own
- K223765: ATEC Lateral Navigation Instruments (2023), 0 descendants of its own

## Indications for use
The Biomet probes/guidewires and dilators are intended for tissue dilation and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.

Source page: https://510kreport.com/device/K132373
Methodology: https://510kreport.com/methodology