Fixone Biocomposite Interference Screw— 510(k) K193497
Substantially EquivalentAju Pharm Co., Ltd.
FDA 510(k) clearance K193497 for Fixone Biocomposite Interference Screw, Substantially Equivalent on 2021-01-05. Applicant: Aju Pharm Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Aju Pharm Co., Ltd.
- Product code
- 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
- Seongnam-Si, KR
Recent devices under product code HWC
view allMore clearances from Aju Pharm Co., Ltd.
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 →
Recalls naming K193497
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 K193497.
Data sourced from openFDA. This site is unofficial and independent of the FDA.