NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM— 510(k) K100111
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K100111 for NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM, Substantially Equivalent on 2010-04-12. 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
view allMore clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- 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 K100111
K-number listed on FDA's recall record- Z-0304-2020 — NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014
- Z-0329-2020 — Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100111.
Data sourced from openFDA. This site is unofficial and independent of the FDA.