REGENEREX PATELLA COMPONENTS— 510(k) K083782
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K083782 for REGENEREX PATELLA COMPONENTS, Substantially Equivalent on 2009-04-03. Applicant: Biomet Manufacturing Corp. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code MBH
view allMore clearances from Biomet Manufacturing Corp
view allAdverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
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 K083782
K-number listed on FDA's recall record- Z-2146-2020 — Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
- Z-2068-2017 — Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Complete Knee System. 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083782.
Data sourced from openFDA. This site is unofficial and independent of the FDA.