Augment Off-Axis Instrument System— 510(k) K241043
Substantially EquivalentFix Surgical
FDA 510(k) clearance K241043 for Augment Off-Axis Instrument System, Substantially Equivalent on 2024-05-15. Applicant: Fix Surgical. Device class: 2.
Clearance details
- Applicant
- Fix Surgical
- Product code
- Code PHX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Conshohocken, PA, US
Recent devices under product code PHX
view allMore clearances from Fix Surgical
view allAdverse events under product code PHX
product code PHX- Death
- 10
- Injury
- 9,705
- Malfunction
- 1,252
- Total
- 10,967
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 →
Recalls naming K241043
K-number listed on FDA's recall record- Z-2527-2026 — Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
- Z-2528-2026 — Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
- Z-2529-2026 — Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
- Z-2530-2026 — Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- Z-2531-2026 — Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241043.
Data sourced from openFDA. This site is unofficial and independent of the FDA.