Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem
FDA 510(k) K052990 · Biomet, Inc.
510(k) numberK052990
Submission
- Device name
- Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- October 24, 2005
- Decision date
- December 16, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
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| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
Questions and answers
When was Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem cleared by the FDA?
Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem (K052990) received a 510(k) decision of Substantially Equivalent on December 16, 2005, 53 days after the submission was received.
What is the product code of K052990?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.