Exactech, Model Pmma Femoral Stem Centralizer
FDA 510(k) K020291 · Exactech, Inc.
510(k) numberK020291
Submission
- Device name
- Exactech, Model Pmma Femoral Stem Centralizer
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- January 28, 2002
- Decision date
- February 27, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| K243448 | Equinoxe® Shoulder SystemPHX · Traditional | 08/01/2025SE |
| K243275 | Equinoxe® Scapula Fracture SystemHRS · Traditional | 06/26/2025SE |
| K243839 | Alteon® HA Femoral StemsMEH · Traditional | 03/10/2025SE |
| K240393 | Exactech® TRULIANT® Knee SystemMBH · Traditional | 10/03/2024SE |
| K233482 | Equinoxe® Central Screw Baseplate SystemPHX · Traditional | 07/18/2024SE |
| K230717 | Exactech® Vantage® Total Ankle SystemHSN · Traditional | 10/12/2023SE |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS · Traditional | 09/25/2023SE |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX · Traditional | 09/14/2023SE |
Questions and answers
When was Exactech, Model Pmma Femoral Stem Centralizer cleared by the FDA?
Exactech, Model Pmma Femoral Stem Centralizer (K020291) received a 510(k) decision of Substantially Equivalent on February 27, 2002, 30 days after the submission was received.
What is the product code of K020291?
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.