TigerShark M Modular Interbody System

No FDA recalls found in the data synced 25 Oct 2026.

Full name

ChoiceSpine TigerShark™ M, Modular Interbody System

510(k) Number

K220953 ↗

FDA Product Code

MAX

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System

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See all devices from Choice Spine LLC →

• What types of spinal procedures is the ChoiceSpine TigerShark M system designed for, and how does its modularity benefit the surgeon?

  The ChoiceSpine TigerShark M is specifically designed for posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) procedures at one or two contiguous levels from L2 to S1. Its modular components allow for adjustable lordosis (6° and 12° angles) and self-distraction, enabling surgeons to restore disc height and spinal alignment precisely during surgery. This flexibility helps tailor the implant to the patient’s anatomy, improving fit and alignment outcomes.

• Is the ChoiceSpine TigerShark M system reusable, or is it intended for single-use only? How does this affect its clinical use?

  The ChoiceSpine TigerShark M system is explicitly intended for single-use only in surgical procedures. This design choice aligns with modern medical device standards to minimize infection risks and ensure consistent performance. Clinicians should follow the manufacturer’s instructions for sterilization (if applicable to reusable systems) or proper disposal protocols, though no reprocessing is recommended for this device.

• What are the available sizes and height adjustments for the ChoiceSpine TigerShark M, and how does this range support different patient anatomies?

  The system offers insertion heights starting at 7–8mm (minimum) and can expand up to 15–17mm through self-distraction, accommodating varying disc spaces. The modular titanium alloy design includes 3D-printed components and two lordotic angles (6° and 12°), allowing surgeons to select the optimal configuration for lumbar spine fusion at levels L2 to S1. This range ensures adaptability to different patient anatomies and spinal alignments.

• How is the ChoiceSpine TigerShark M system packaged and prepared for surgical use? Are there specific storage requirements?

  While the exact packaging details aren’t specified, the system is supplied as a sterile, single-use modular device for surgical use. As with most spinal implants, it should be stored in a clean, dry environment protected from moisture and extreme temperatures until use. Clinicians should refer to the manufacturer’s instructions for unpacking and handling to maintain sterility and functionality prior to surgery.

• What regulatory pathway was followed for FDA clearance of the ChoiceSpine TigerShark M, and what does this mean for clinicians using the device?

  The ChoiceSpine TigerShark M received FDA 510(k) clearance under the Traditional review pathway (K-number: K220953), with a decision dated September 13, 2022. This means the device was deemed substantially equivalent to a legally marketed predicate device and meets FDA safety and effectiveness requirements for intervertebral body fusion. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should always follow the device’s labeled indications and surgical techniques.