Arthrex Puddu Osteotomy System
510(k) K973812
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973812 | Date10 Jun 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Arthrex Puddu Osteotomy System is a surgical instrument set designed for performing opening wedge osteotomies. It is classified as a High-Risk Surgical Device (Product Code: HRS) and is intended for use in orthopedic procedures to correct lower extremity malalignment by creating controlled bone cuts. The system facilitates reproducible osteotomies, aiding in the treatment of pain or instability associated with deformities in the tibia or femur. Its use is supported by FDA clearance under a 510(k) submission (K973812).
This system is supplied as a reusable surgical instrument set and is regulated under the FDA’s Orthopedic Advisory Committee (OR). The device is intended for use in sterile operating room environments by trained orthopedic surgeons. No specific MRI safety classification or sterility assurance (e.g., single-use vs. reusable) is stated in the regulatory data. Storage and handling instructions are not provided in the available specifications.
Other devices from Arthrex, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Arthrex Puddu Osteotomy System used for?
The Arthrex Puddu Osteotomy System is designed specifically for performing opening wedge osteotomies in orthopedic surgery. It helps correct lower extremity malalignment by enabling controlled bone cuts in the tibia or femur. This procedure is typically used to address pain or instability caused by deformities, improving joint mechanics and patient mobility.
Is the Puddu Osteotomy System reusable or single-use?
The Arthrex Puddu Osteotomy System is supplied as a reusable surgical instrument set. Reusability is common for high-risk surgical devices like this one, as it allows for sterilization between procedures. However, proper sterilization protocols must be followed to ensure patient safety and device integrity.
Who should perform procedures using this system?
This system is intended for use by trained orthopedic surgeons in sterile operating room environments. The complexity of the procedure—requiring precise bone cuts and alignment—demands specialized expertise to ensure accurate and safe execution.
Are there specific storage instructions for the Puddu Osteotomy System?
The available regulatory data does not provide explicit storage instructions for the Arthrex Puddu Osteotomy System. However, as a reusable surgical instrument, it should be stored in a clean, dry environment to prevent contamination. Proper handling and maintenance are critical to preserve functionality and sterility between uses.
How was the FDA clearance for this device determined?
The Arthrex Puddu Osteotomy System received FDA clearance under a 510(k) submission (K973812) with a decision described as ‘Substantially Equivalent’ to a predicate device. This classification means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets regulatory standards for safety and effectiveness.