ARCOMXL ACTIVE ARTICULATION— 510(k) K110555
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K110555 for ARCOMXL ACTIVE ARTICULATION, Substantially Equivalent on 2011-03-24. Applicant: Biomet Manufacturing Corp. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code LPH
view allMore clearances from Biomet Manufacturing Corp
view allAdverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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 K110555
K-number listed on FDA's recall record- Z-1024-2017 — RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
- Z-1025-2017 — Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110555.
Data sourced from openFDA. This site is unofficial and independent of the FDA.