Legend All-Poly Cup
FDA 510(k) K051407 · Ortho Development Corp.
510(k) numberK051407
Submission
- Device name
- Legend All-Poly Cup
- Applicant
- Ortho Development Corp.
Draper, UT, US - Received
- May 31, 2005
- Decision date
- September 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
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| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
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| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | 12/19/2025SE |
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| K242984 | BKS Revision SystemJWH · Special | 10/25/2024SE |
| K242833 | Legend® Acetabular ShellLPH · Special | 10/11/2024SE |
| K233758 | Trivicta Hip StemMEH · Traditional | 03/08/2024SE |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial InsertJWH · Special | 10/25/2023SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
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| K203023 | Pisces Spinal SystemNKB · Traditional | 07/14/2021SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | 03/31/2020SE |
Questions and answers
When was Legend All-Poly Cup cleared by the FDA?
Legend All-Poly Cup (K051407) received a 510(k) decision of Substantially Equivalent on September 8, 2005, 100 days after the submission was received.
What is the product code of K051407?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.