# K970345: Alignment Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Apr 29, 1997 after 90 days
- Product code: HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Alignment instrument, type 8731: named in the summary without a submission number
- (no number) Alignment instrument, type AR 1875: named in the summary without a submission number
- (no number) Pneumatic drill, type GA 207: named in the summary without a submission number
- (no number) Coring Reamer, type AR-1223CR: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K940125: ACL-Drill Guide Instrument, type 8870.152. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The ACL instruments are used for the reconstruction of anterior cruciate ligament with the patellar ligament using the press-fit technique. The drill alignment device ensures precise drilling of the tibial channel. The pneumatic drill drives the oscillating hollow drills. The short hollow drill is used for graft removal from the ligament. The long hollow drill with ejector is used for removing the tibial bone plug used for filling in the graft-removal defects on the patella and the tibia. The ejector ensures the correct drilling direction and permits subsequent ejection of the bone for the hollow drill.

Source page: https://510kreport.com/device/K970345
Methodology: https://510kreport.com/methodology