510(k) · Cleared
ClearedAlignment Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Cleared on Apr 29, 1997 after a 90-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Apr 29, 1997
- Review
- 90 days
- Class
- Class I
- Product code
- HSZ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…8869.911 8869.841 8869.842 || Common name: o Classification name: It ACL instruments | o devic P | Il 510() Number Trade or propnetary or model name Manufacturer | 1 K940125 1 ACL-Drill Guide Instrument, type 8870.152 1 Richard Wolf | ' 2 Alignment instrument, type 8731 2 Linvatec it 7 3 Alignment inst… | |
| * | — | Alignment instrument, type 8731 Named without a submission number | |
| * | — | Alignment instrument, type AR 1875 Named without a submission number | |
| * | — | Pneumatic drill, type GA 207 Named without a submission number | |
| * | — | Coring Reamer, type AR-1223CR Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HSZ devicesHSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSZ
FDA has decided no HSZ device since 2007.
Median 510(k) review, days · HSZ
Too few HSZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HSZ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSZ
4in 2025
MAUDE reports naming product code HSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 111 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 1 | 411 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 27 |
| 2017 | 0 | — | 0 | 24 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970345: Alignment Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970345
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026