Arthrex Sterile VAL and VAL KreuLock Compression Screw System— 510(k) K260809
Substantially EquivalentArthrex, Inc.
FDA 510(k) clearance K260809 for Arthrex Sterile VAL and VAL KreuLock Compression Screw System, Substantially Equivalent on 2026-06-25. Applicant: Arthrex, Inc.. Device class: 2.
Summary
Arthrex's clearance names the Sterile VAL and VAL KreuLock Compression Screw System, filed under HWC, bone fixation screws. The record doesn't expand "VAL" or list screw sizes.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Arthrex filed from Naples, Florida. The decision came 105 calendar days after receipt (March 12 to June 25, 2026).
Clearance details
- Applicant
- Arthrex, Inc.
- Product code
- Product code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naples, FL, US
Recent devices under product code HWC
view allMore clearances from Arthrex, Inc.
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.