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FDA 510(k)

Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

K-Number: K240175 · 2024-10-29

ApplicantTigon Medical
Decision Date2024-10-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is a medical device manufactured by Tigon Medical. It received FDA 510(k) clearance on 2024-10-29 under approval number K240175. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is a medical device that received FDA 510(k) clearance on 2024-10-29. It is manufactured by Tigon Medical. The 510(k) number is K240175.

When was Tigon Medical Fractures, Instability, and Reconstruction (FIRE) approved by the FDA?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) received FDA 510(k) clearance on 2024-10-29, under approval number K240175.

What company makes Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is manufactured by Tigon Medical.

What is the FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE)?

The FDA product code for Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT05337696 Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant TERMINATED NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT05264389 Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction ACTIVE_NOT_RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT07060131 Observe the Effects of Far Infrared Eye Masks on Acupoints Around the Eyes in Patients With Dry Eye Syndrome COMPLETED NCT06829667 Retrospective Study of Suture Tape for Soft Tissue Reconstruction in Patients Suffering From Lateral Ankle Instability COMPLETED

Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41886162 Clinical Applications of Biophysical Stimuli Technologies for Bone Healing. Annals of biomedical engineering (2026) PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026) PMID: 41034609 Influence of geometry, reinforcement, and sterilisation on the dimensional accuracy of additively manufactured carbon fibre-reinforced nylon composites. Scientific reports (2025)

Other Devices by Tigon Medical

K182507Tigon Medical Tissue Anchors K211049Tigon Medical Button System K220464Tigon Medical Gryphon Anchor Line K242529Tigon Medical All-Suture Anchors (ASA) K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

View all 7 devices →

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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