Synthes Anterior Cervical Locking Plate (ACLP) System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031276 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K993314 Active Cleared 6 Dec 1999

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  FDA 510(k) K092247 Active Cleared 25 Sep 2009

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  FDA 510(k) K991407 Active Cleared 11 Jun 1999

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See all devices from Synthes (Usa) →

• What is the Synthes ACLP System used for?

  The Synthes Anterior Cervical Locking Plate (ACLP) System is designed specifically for anterior cervical spine fixation. It provides stable internal support during spinal stabilization procedures, particularly in cases requiring multi-level cervical spine alignment. The one-step locking mechanism ensures secure attachment of titanium alloy plates and screws to the cervical vertebrae, reducing the risk of hardware loosening.

• How is the ACLP System supplied, and is it reusable?

  The ACLP System is supplied as a sterile, single-use orthopedic implant set. This ensures patient safety by preventing cross-contamination and maintaining sterility. The plates are pre-lordosed to match cervical anatomy, reducing the need for manual bending during surgery. Reuse is not recommended due to potential compromise of sterility and mechanical integrity over repeated use.

• What plate lengths and screw configurations are available?

  The ACLP System offers plates designed for one- to four-level cervical spine procedures. Each plate is engineered to accommodate a minimum of four screws for secure fixation. The conical head screws are engineered to lock into the plate, ensuring stability. The system’s modular design allows for customization based on the specific surgical requirements of the patient’s cervical anatomy.

• How should the ACLP System be stored?

  The ACLP System must be stored and handled according to sterile medical device protocols to maintain its integrity and sterility. This includes keeping the packaging unopened until use and storing it in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains ready for surgical use without compromising its performance or safety.

• Is the ACLP System regulated by the FDA?

  Yes, the Synthes ACLP System has received FDA 510(k) clearance under the reference number K031276. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for safety and effectiveness in its intended use for anterior cervical spine fixation.