ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES— 510(k) K082078
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K082078 for ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES, Substantially Equivalent on 2008-11-03. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code HRS
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- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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 K082078
K-number listed on FDA's recall record- Z-0317-2020 — Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 47235800619 47235800705 47235800711 47235800715 47235800803 47235800805 47235800807 47235800811 47235800815 47235800911 47235800913 47235800915 47235801209 47235801211 47235801213 47235801215 47235802305 47235802307 47235802311 47235802315 47235802405 47235802407 47235802409 47235802411 47235802415 47235810707 47235810711 47235810715 47235810805 47235810807 47235810811 47235810815
- Z-0585-2014 — FEM COND BUTTRESS PLT, RT.
- Z-0587-2014 — DIST LAT FEM LOCK PLT, LT
- Z-0588-2014 — DIST LAT FEM LOCK PLT, RT
- Z-0589-2014 — ITST THREADED GUIDE PIN
- Z-0591-2014 — FEM COND BUTTRESS PLT, LT
- Z-2101-2013 — ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082078.
Data sourced from openFDA. This site is unofficial and independent of the FDA.