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CyclaPlex Implant

ALPHAMET LTD · Model V7 · UDI-DI 07290017626017

HTN Prescription

510(k) clearances

1,514

Adverse events (2 deaths)

Recalls

265

Facilities

Description

The implant is comprised of two metallic bone screws ("Anchor1", "Anchor 2") connected by an UHMW polyethylene multiple suture cord. The implant device pulls the 1st metatarsal inward, towards the 2nd metatarsal and reduces the intermetatarsal angle to normal medically-accepted values. It is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the first intermetatarsal angle.

Recalls

Date	Firm	Reason
2022-12-22	TriMed Inc.	Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to b
2019-10-10	Zimmer Biomet, Inc.	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
2016-08-12	Arthrex, Inc.	The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
2013-10-03	Synthes USA HQ, Inc.	During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.