Depuy Ace Universal and Troch Entry Femoral Nail Systems
FDA 510(k) K033329 · Depuy, Inc.
510(k) numberK033329
Submission
- Device name
- Depuy Ace Universal and Troch Entry Femoral Nail Systems
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- October 16, 2003
- Decision date
- November 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
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| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
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Questions and answers
When was Depuy Ace Universal and Troch Entry Femoral Nail Systems cleared by the FDA?
Depuy Ace Universal and Troch Entry Femoral Nail Systems (K033329) received a 510(k) decision of Substantially Equivalent on November 14, 2003, 29 days after the submission was received.
What is the product code of K033329?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.