Synthes Metallic Spiked Washers
by Synthes (Usa) 510(k)
Active
510(k) K013806
Overview
The Synthes Metallic Spiked Washers are orthopedic fixation devices classified as Washer, Bolt Nut (Product Code: HTN). These metallic components feature spikes arranged around a central hole, designed to enhance mechanical grip for soft tissue fixation in ligament reattachment procedures. Available in multiple sizes, they accommodate screws ranging from 2.7 mm to 6.5 mm, ensuring compatibility with various surgical applications.
Used in clinical and operating room settings, these washers are intended for single-use and are not sterilized post-manufacture. The FDA granted 510(k) clearance under the Orthopedic (OR) Advisory Committee in 2002, classifying them as Class II – Special Controls. No additional regulatory markings (e.g., MRI safety) or sterility assurances are specified in the submission data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013806 | Date8 Feb 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synthes (Usa)
Questions
What are the Synthes Metallic Spiked Washers used for?
These washers are designed for orthopedic ligament reattachment procedures, where their metallic spikes create a mechanical grip to secure soft tissue during fixation. The spiked edges distribute force more effectively than smooth washers, reducing slippage and improving stability in surgical applications.
Are these washers reusable or single-use?
The Synthes Metallic Spiked Washers are intended for single-use only. They are not sterilized post-manufacture, meaning each package is meant to be opened once and discarded after use to maintain sterility and prevent cross-contamination in clinical settings.
What screw sizes do these washers accommodate?
The washers are engineered to fit screws ranging from 2.7 mm to 6.5 mm in diameter, ensuring compatibility with a variety of orthopedic fixation systems. The central hole’s diameter corresponds to these sizes, allowing secure attachment while maintaining the spiked grip mechanism.
How are they supplied, and what sterility assurances exist?
These washers are supplied sterile as manufactured, packaged individually for single-use. The manufacturer does not provide additional post-manufacture sterilization, so each sealed package should be treated as sterile until opened. Always follow facility protocols for handling sterile orthopedic implants.
What regulatory pathway was followed for clearance?
The Synthes Metallic Spiked Washers received FDA 510(k) clearance in 2002 under the Orthopedic (OR) Advisory Committee, classified as Class II – Special Controls. The submission demonstrated substantial equivalence to a predicate device, validating their safety and effectiveness for the intended use in ligament reattachment procedures.