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Ascension® Silicone PIP

Ascension Orthopedics, Inc. · Model SPIP5204WW · UDI-DI 10381780116332

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510(k) clearances

494

Adverse events

Recalls

Facilities

Description

The Ascension silicone PIP is an anatomically designed, single use, one piece, flexible hinge prosthesis designed to be implanted without bone cement across the proximal interphalangeal (PIP) joint. It is made from medical grade silicone elastomer. The proximal and distal stems of the prosthesis are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. the PIP provides 90 degrees of flexion from full extension. The Ascension PIP finger joint prostheses is intended for cementless replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis.

Recalls

Date	Firm	Reason
2025-06-18	Osteotec Limited	There is the potential that the silicone implant may contain foreign material
2019-11-04	Integra Lifesciences Sales Llc	Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
2016-11-08	Wright Medical Technology, Inc.	The firm discovered a lack of adequate documentation confirming sterility on certain products.
2016-11-08	Wright Medical Technology, Inc.	The firm discovered a lack of adequate documentation confirming sterility on certain products.

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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.