Ortho Development Corporation
Ortho Development Corporation holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2023, with 8 FDA device recalls on record.
Top product codes for Ortho Development Corporation
FDA recalls by Ortho Development Corporation
- Z-1903-2020 — Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
- Z-1904-2020 — Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
- Z-2255-2014 — PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
- Z-2257-2014 — Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
- Z-2253-2014 — Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
- Z-2256-2014 — Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
- Z-2254-2014 — Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
- Z-1610-2014 — PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ortho Development Corporation
- K233093 — Balanced Knee® System TriMax PS Plus Tibial Insert
- K211086 — The Progen Trochanteric Nail System
- K211471 — Balanced Knee System Uni
- K203023 — Pisces Spinal System
- K200281 — The Gecko Spinal System
- K182085 — Balanced Knee Revision System Trabecular Tibial Cone Augments
- K181569 — BKS Revision Sleeves System
- K180743 — Balanced Knee Revision System - Offset Junction Box
- K173951 — Legend Acetabular Liners
- K171249 — Entrada hip stem
- K162995 — Ibis® Pedicle Screw System
- K161080 — Escalade Legend Acetabular Shell
- K153216 — Alpine Cemented Hip System
- K152169 — Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts
Data sourced from openFDA. This site is unofficial and independent of the FDA.