8MM Forged Cemented Stem
FDA 510(k) K991227 · Encore Orthopedics, Inc.
510(k) numberK991227
Submission
- Device name
- 8MM Forged Cemented Stem
- Applicant
- Encore Orthopedics, Inc.
Austin, TX, US - Received
- April 12, 1999
- Decision date
- June 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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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| K032905 | 3DKNEE Porous Coated Femoral ComponentMBH · Traditional | 07/06/2004SE |
| K020114 | 3D KneeJWH · Traditional | 07/12/2002SE |
| K020741 | Unicondylar KneeHRY · Traditional | 06/04/2002SE |
| K020236 | Modification to Pass Spinal SystemKWP · Special | 02/14/2002SE |
| K020170 | Keystone Hip System Calcar Replacement Body and Build UpLPH · Special | 02/11/2002SE |
| K013490 | Cemented Calcar Hip SystemLPH · Traditional | 01/17/2002SE |
| K013442 | Pass Spinal SystemKWP · Traditional | 01/15/2002SE |
| K003324 | Plasma Sprayed ShoulderKWS · Traditional | 12/06/2001SE |
| K013431 | Pass Spinal SystemMNI · Special | 11/15/2001SE |
| K013191 | Pass Spinal SystemMNI · Special | 10/24/2001SE |
Questions and answers
When was 8MM Forged Cemented Stem cleared by the FDA?
8MM Forged Cemented Stem (K991227) received a 510(k) decision of Substantially Equivalent on June 1, 1999, 50 days after the submission was received.
What is the product code of K991227?
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.