36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)— 510(k) K022077
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K022077 for 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT), Substantially Equivalent on 2002-07-25. Applicant: Howmedica Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Allendale, NJ, US
Recent devices under product code JDI
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- K253434 — OSSTM Orthopedic Salvage System
- K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
More clearances from Howmedica Osteonics Corp.
view all- K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
- K130895 — REUNION RSA SHOULDER SYSTEM
- K123604 — ABG III MONOLITHIC HIP STEM
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
Adverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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 K022077
K-number listed on FDA's recall record- Z-2292-2018 — LFIT Anatomic CoCr Femoral Heads, 6260-9-036
- Z-2293-2018 — LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
- Z-2294-2018 — LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
- Z-2295-2018 — LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
- Z-2296-2018 — LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
- Z-2297-2018 — LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
- Z-2298-2018 — LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
- Z-2299-2018 — LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
- Z-0378-2017 — LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022077.
Data sourced from openFDA. This site is unofficial and independent of the FDA.