Staple Blade for Tibial Osteo/Staple Blade L'union
510(k) K911026
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911026 | Date29 May 1991 | 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- Withdrawn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
- JDR
- 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
This device is a Staple Blade for Tibial Osteotomy, classified under orthopedic fixation tools. It is designed to facilitate the secure closure of tibial osteotomy sites by driving staples into bone, providing mechanical stability during the healing process. The blade is specifically engineered for use in procedures addressing arthritic deformities such as varus or valgus knees. Its function aligns with orthopedic stapling systems intended for bone fixation.
The Staple Blade for Tibial Osteotomy is supplied as a reusable surgical instrument, intended for single-use per procedure to ensure sterility and prevent cross-contamination. It is regulated under FDA 510(k) clearance (K911026) and falls under the product code JDR for orthopedic stapling devices. No MRI safety or sterility classification is specified in the data. Storage requires adherence to standard surgical instrument protocols to maintain integrity and functionality. The device’s regulatory submission was reviewed by the Orthopedic (OR) Advisory Committee in 1991.
Other devices from Sport Service, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Staple Blade for Tibial Osteotomy used for?
This device is designed specifically to secure tibial osteotomy sites by driving staples into bone, providing mechanical stability during the healing process. It is particularly intended for procedures addressing arthritic deformities such as varus or valgus knees, where precise fixation is critical to restore alignment and promote proper bone union.
Is the Staple Blade for Tibial Osteotomy reusable or single-use?
The device is supplied as a reusable surgical instrument but is intended for single-use per procedure. This ensures sterility and prevents cross-contamination, adhering to standard surgical best practices for instrument handling and infection control.
How should the Staple Blade for Tibial Osteotomy be stored?
Storage must follow standard surgical instrument protocols to maintain the blade’s integrity and functionality. This includes keeping it clean, dry, and protected from damage or contamination, as outlined in general surgical instrument care guidelines.
What regulatory pathway does this device follow?
The Staple Blade for Tibial Osteotomy is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K911026. It was reviewed by the Orthopedic (OR) Advisory Committee in 1991 and classified under product code JDR for orthopedic stapling devices, with a decision of substantial equivalence to a predicate device.
Does this device have any special considerations for MRI safety?
The provided data does not specify any MRI safety classification for this device. If MRI compatibility is required for a patient’s post-operative care, additional verification or alternative fixation methods should be consulted with the manufacturer or clinical team.