Fixone Biocomposite Anchor— 510(k) K230892
Substantially EquivalentAju Pharm Co., Ltd.
FDA 510(k) clearance K230892 for Fixone Biocomposite Anchor, Substantially Equivalent on 2023-06-09. Applicant: Aju Pharm Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Aju Pharm Co., Ltd.
- Product code
- Code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Seongnam-Si, KR
Recent devices under product code MAI
view allMore clearances from Aju Pharm Co., Ltd.
view allAdverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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 K230892
K-number listed on FDA's recall record- Z-1166-2026 — Fixone Hybrid Anchor
- Z-1167-2026 — Fixone Biocomposite Anchor
- Z-1168-2026 — Genesis Screw-In Anchor
- Z-1169-2026 — Genesis Dual Thread Screw-In Anchor
- Z-1170-2026 — Genesis Knotless Anchor
- Z-1171-2026 — Genesis Push-In Suture Anchor
- Z-1172-2026 — AlternatiV+ Max Knotless Anchor
- Z-1173-2026 — AlternatiV+ Screw-In Anchor
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230892.
Data sourced from openFDA. This site is unofficial and independent of the FDA.