Fine Osteotomy
by Bodycad Laboratories, Inc. 510(k)
Active
510(k) K240066
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240066 | Date9 Feb 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- PBF
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Fine Osteotomy is a patient-specific orthopedic surgical guide and implant system designed for precise deformity correction. Classified under Orthopaedic Surgical Planning and Instrument Guides, it aids in the accurate execution of osteotomies by providing customised alignment and cutting templates tailored to individual patient anatomy.
Supplied as a reusable or single-use device (as indicated by the registration numbers), the Fine Osteotomy is intended for use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K240066) and falls under device class II (PBF product code). Sterility and MRI safety are not specified in the provided data, but its use is restricted to qualified surgical environments for orthopedic procedures.
Other devices from Bodycad Laboratories, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of orthopedic procedures is the Fine Osteotomy designed to assist with, and how does it ensure precision?
The Fine Osteotomy is a patient-specific surgical guide and implant system tailored for precise deformity correction in orthopedic procedures. It provides customised alignment and cutting templates designed to match individual patient anatomy, ensuring accurate osteotomy execution. This customisation helps surgeons achieve consistent and predictable results by reducing human error in bone-cutting alignment during procedures like limb deformity corrections or joint realignments.
Is the Fine Osteotomy reusable or single-use, and how should I determine which version I need?
The Fine Osteotomy is available in both reusable and single-use versions, as indicated by the registration numbers in the data. To determine which version you need, check the specific registration number associated with your order or consult the manufacturer’s documentation. Reusable versions are designed for repeated use in controlled surgical environments, while single-use versions are intended for one-time procedures to ensure sterility and reduce cross-contamination risks.
What storage requirements should I follow for the Fine Osteotomy to maintain its integrity?
The Fine Osteotomy should be stored in a clean, dry environment protected from physical damage, moisture, and contamination, as it is intended for use in qualified surgical settings. Since sterility and MRI safety are not specified, avoid exposure to magnetic fields or harsh chemicals. Follow the manufacturer’s guidelines for packaging and storage to preserve accuracy and functionality, especially if the device is reusable.
How do I verify whether the Fine Osteotomy I’m considering has been cleared by the FDA?
The Fine Osteotomy holds an FDA 510(k) clearance under the registration number K240066 and is classified under product code PBF (Orthopaedic Surgical Planning and Instrument Guides). To verify its regulatory status, you can reference the FDA’s openFDA database using the k_number (K240066) or check the registration numbers listed in the data. This clearance confirms it meets FDA standards for safety and effectiveness as a Class II device.