TITAN TIBIAL NAIL— 510(k) K003018
Substantially EquivalentHowmedica Osteonics Corp.
FDA 510(k) clearance K003018 for TITAN TIBIAL NAIL, Substantially Equivalent on 2000-12-15. Applicant: Howmedica Osteonics Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp.
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Recent devices under product code HSB
view all- K261481 — Pangea Femur Reconstruction System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
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 HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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 K003018
K-number listed on FDA's recall record- Z-2374-2020 — Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Z-2375-2020 — Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Z-2380-2020 — Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Z-2383-2020 — Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Z-2393-2018 — Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
- Z-2394-2018 — Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
- Z-2395-2018 — Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
- Z-2396-2018 — Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
- Z-2397-2018 — Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
- Z-2398-2018 — Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
- Z-2399-2018 — Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
- Z-2400-2018 — Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
- Z-2401-2018 — Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
- Z-2402-2018 — Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
- Z-2403-2018 — Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
- Z-2404-2018 — Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
- Z-2405-2018 — Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
- Z-2406-2018 — Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
- Z-2407-2018 — Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
- Z-2408-2018 — Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003018.
Data sourced from openFDA. This site is unofficial and independent of the FDA.