Lsf* Total Hip System
FDA 510(k) K855017 · Implant Technology, Inc.
510(k) numberK855017
Submission
- Device name
- Lsf* Total Hip System
- Applicant
- Implant Technology, Inc.
Secaucus, NJ, US - Received
- December 16, 1985
- Decision date
- June 11, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| 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 |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K921525 | Hip Joint Metal/Polymer Semi-Constrained ProthesisLPH · Traditional | 01/11/1995SE |
| K915617 | LSF Ha Coated Femoral HipMEH · Traditional | 05/28/1992SE |
| K920021 | LSF Total Hip System - Muller-Type Acetabular CupJDI · Traditional | 03/25/1992SE |
| K913616 | LSF Diagnostic Related Group Cemented HipJDI · Traditional | 11/07/1991SE |
| K902727 | LSF Cemented Femoral HipJDI · Traditional | 08/09/1990SE |
| K901460 | Lsf(Tm) Total Hip SystemJDI · Traditional | 05/22/1990SN |
| K891472 | Implant Technology Bone Cement ExtractorLZV · Traditional | 05/02/1989SE |
| K884432 | Modified LSF Total Hip SystemJDI · Traditional | 12/09/1988SE |
| K883212 | LSF (R) Total Hip System - Bipolar ComponentKXA · Traditional | 11/22/1988SE |
| K841546 | Communi-Trach TubeBTO · Traditional | 04/30/1984SE |
Questions and answers
When was Lsf* Total Hip System cleared by the FDA?
Lsf* Total Hip System (K855017) received a 510(k) decision of Substantially Equivalent for Some Indications on June 11, 1986, 177 days after the submission was received.
What is the product code of K855017?
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.